Feasibility study of an experimental social space-oriented rehabilitation concept for people with intellectual and/or multiple disabilities: a study protocol

Abstract

Introduction

The United Nations underlines the participation in all domains of daily living for people with intellectual and/or multiple disabilities in the Disability Rights Convention, which also includes medical services. In line with this, the German Federal Participation Act has further developed the relevant disability policy at the national level. This also implies access to comprehensive medical care. In 2015, Germany created a legal basis for the establishment of medical centres for adults with intellectual and/or multiple disabilities in order to ensure basic medical care for these patients. However, the medical centres cannot provide complex rehabilitation. Mobile rehabilitation can be another tool to address the underuse of medical rehabilitation for people with intellectual and/or multiple disabilities. Mobile rehabilitation refers to rehabilitation services provided in a patient’s home or local community, rather than in a traditional inpatient or outpatient rehabilitation facility. The advantages of mobile rehabilitation are its accessibility for patients with mobility problems, the comfort of a familiar environment, which can reduce stress, and the fact that rehabilitation can be tailored to the patient’s living conditions and daily routine. In Germany, mobile rehabilitation is currently only available in the field of geriatrics.

Within the framework of the feasibility study ‘Social space-oriented individualised medical rehabilitation for people with intellectual and/or multiple disabilities (SIMRE),’ a social space-oriented rehabilitation concept was developed to close the rehabilitation gap for people with intellectual and/or multiple disabilities. It is funded by the German Federal Ministry of Health. This study protocol describes the procedure of this feasibility study.

Methods

This study is a prospective mixed methods feasibility study. The rehabilitation concept combines outpatient and home-based rehabilitation, medical, and therapeutic care for people with intellectual and/or multiple disabilities.

Analysis

The primary target criteria are the feasibility and acceptance of the concept by participants, relatives, carers and the rehabilitation staff. Guided interviews with participants and their relatives and/or carers will be analysed using the content-structuring analysis according to Kuckartz. Quantitative analysis will include a cost-benefit analysis to provide information on the economic feasibility of the rehabilitation concept. Changes in individual participation, quality of life and rehabilitation goals will be assessed using a before-and-after comparison with questionnaires. The frequency and type of rehabilitation procedures used will be evaluated quantitatively.

The trial was prospectively registered in the German Clinical Trials Register on 17 August 2023. (https://www.drks.de/DRKS00032493).

Ethics and dissemination

Ethical approval was granted by the Ethics Committee of Hannover Medical School (reference number: 10985_BO_S_2023).

1. Publication: The results of the project will be made available to the public through open access publications. We plan to develop a treatment guideline for the treatment concept based on clinical experience.

2. Widespread implementation: If the project is continued and adequately staffed, the rehabilitative care concept could be implemented nationwide, and the University Hospital could be available as a reference clinic.

Trial registration number

German Clinical Trials Register (reference number: DRKS00032493).

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The rehabilitation concept was newly adopted for the feasibility study.

• Variations in protocol adherence are expected due to the diversity of the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) diagnoses in the enrolled participants.

• The unpredictability of the data in the participants’ medical records is a limitation, as it may affect the analysis and interpretation of the results.

• The sample size of participants is small.

Introduction

Inclusion of people with intellectual and/or multiple disabilities and their participation in all areas of daily life is an important social issue. The United Nations Convention emphasises the participation of people with intellectual and/or multiple disabilities also in medical care (UN-BRK 2009, Artikel 25) in the Disability Rights Convention.¹

In Germany, there are laws on inclusion, participation and medical care. They include the right to medical rehabilitation.^{2 3} However, access to medical care, especially medical rehabilitation, is difficult or impossible for people with intellectual and/or multiple disabilities.4,6

The challenges of rehabilitation for people with intellectual and/or multiple disabilities are based on the specific needs of these patients. Some patients may need more time to prepare for therapies, while others may have problems in unfamiliar places. Some patients need more space for a medical consultation or treatment. They may use a bulky multifunctional wheelchair, need more help in transferring to an examination couch or need more time to communicate. Rehabilitation for people with intellectual and/or multiple disabilities requires a recovery room, not just a disabled toilet. Patients may be accompanied by relatives or caregivers to provide stability and help with daily activities. It is not uncommon to need the support of relatives and carers.

There is a shortage of professionals in healthcare who specialise in caring for people with intellectual and/or multiple disabilities. Institutions are often insufficiently prepared to care for people with intellectual and/or multiple disabilities who may need more time and care.

Since 2015, there have been special medical centres for adults with intellectual and/or multiple disabilities based on new legislation (§119c SGB V).⁷ Interprofessional medical teams provide medical care, including medical consultations and physiotherapy and occupational therapy in specialised medical centres. Administrative procedures, staff and facilities are adapted to the special needs of the patients. These medical centres for adults with intellectual and/or multiple disabilities do not exist nationwide in Germany; moreover, they are not able to provide complex medical rehabilitation.⁸ There is currently only one neuro-orthopaedic inpatient rehabilitation department in Wickede, Germany, which provides rehabilitation and is adapted to the special needs of people with intellectual and/or multiple disabilities. It is able to provide a highly individualised rehabilitation with increased staffing requirements and special professional qualifications in dealing with this group of people, as well as all-round care. A law on mobile rehabilitation (§40 Abs. 1 SGB V) was expanded in 2021 to include a number of indications.⁹ A law on mobile rehabilitation (§40 Abs. 1SGB V) provides a solution to the lack of care for people with intellectual and/or multiple disabilities.⁹ Its implementation has not yet been successful so far or focused on the geriatric area.⁴ In conclusion, there is still a gap in the provision of medical rehabilitation for people with intellectual and/or multiple disabilities. For this reason, a new social space-oriented rehabilitation concept has been developed and proofed.

Social space refers to a person’s living environment, which is defined by spatial structures and reference persons.¹⁰ Social space-oriented medical rehabilitation means that this very individual and personal environment is included in medical rehabilitation. When dealing with people with mental and/or multiple disabilities, the individual social space plays a special role due to personal needs, personal requirements and access barriers. Leaving the social environment, eg, the absence of carers, getting to know new people or premises, can be a significant stressor for this vulnerable group of people. This can manifest itself in challenging behaviour and physical symptoms. The consideration of personal contextual factors in rehabilitation is in line with the ICF.¹¹

This feasibility study evaluates a newly developed social space-oriented rehabilitation concept, which aims to fill the gap in medical rehabilitation for patients with intellectual and/or multiple disabilities in an experimental manner. This study protocol describes the process of the feasibility study ‘Social space oriented individualised medical rehabilitation for people with intellectual and/or multiple disabilities (SIMRE)’.

The specific aims are:

1. To prove the feasibility of the rehabilitation concept.

2. To evaluate the acceptance of the rehabilitation concept by participants, relatives, carers, and rehabilitation staff members.

3. Evaluation of patient-reported outcome measures, for example, participants’ self-reported participation, rehabilitation goals achieved and quality of life.

A very short project timeframe, which started with challenging ethics application tasks, including translating the project documents into plain language, meant that the author team was not able to publish the study protocol until after recruitment of the first participant had started. Recruitment and data collection were still ongoing at the time of manuscript submission.

Methods

Design and setting

This exploratory feasibility study is a monocentric, prospective study with a mixed-methods approach. The developed rehabilitation concept provides a combination of outpatient therapies and home visits for medical as well as physiotherapy and occupational therapy care. The outpatient therapies will be provided in the outpatient department of a university hospital in Germany in accordance with the legal requirements for routine care. A special feature of this project is that physicians and therapists will have more time than in regular care settings. Researchers will accompany and monitor the processes and evaluate the feasibility.

The study is planned to last 18 months and is funded by the German Federal Ministry of Health. Ethical approval has been granted by the Ethics Committee of Hannover (V.1, reference number: 10985_BO_S_2023). Any changes must be notified to the Federal Ministry of Health and the Ethics Committee of Hannover Medical School. The study will run from 1 June 2023 to 30 November 2024. The trial has been registered at the German Clinical Trials Register (reference number: DRKS00032493). The study protocol complies with the Standard Protocol Items: Recommendations for International Trials (SPIRIT) guidelines.¹² The SPIRIT checklist can be found in online supplemental file 1. The intervention was reported using the Template for Intervention Description and Replication (TIDieR)¹³ (see online supplemental file 2).

Patient and public involvement

Patients and/or public are not involved in the design, conduct, reporting or dissemination plans of this research.

Rehabilitation concept

In Germany, regular outpatient physiotherapy and occupational therapy sessions take place one to three times a week. The physician also prescribes whether the therapies take place in the practice rooms or at home. An occupational therapy session usually lasts 30 or 45 min while a physiotherapy session lasts 20 or 40 min. Due to the special needs of people with intellectual and/or multiple disabilities, the duration of therapy is usually insufficient for this group of patients. Co-therapy with a physiotherapist and an occupational therapist is not usually provided in the outpatient setting. Regular inpatient rehabilitation usually does allow for longer therapy sessions. Accompaniment by relatives or carers to inpatient rehabilitation is not common. Relatives and carers play a central role in the patients’ lives because they are often familiar with the patient’s particular needs, help with activities of daily living and provide stability for the patient.

The rehabilitation concept of this trial will allow rehabilitation that is better adapted to the specific needs and abilities of the patients enrolled: longer duration of the therapies where appropriate, participation of relatives and carers, and a flexible setting. Flexible setting means that the therapies can take place in the patient’s home, workplace or in the outpatient clinic, depending on the patient’s therapy goals.

The therapy includes regular consultations with a physician in the outpatient department and at home. According to German healthcare regulations, the physician must initiate the therapy by prescribing the physiotherapy and occupational therapy remedies.

The physiotherapist and occupational therapists will provide therapies based on the participants’ individual rehabilitation goals, which will also reflect their participation goals. If necessary, nutritional counselling and/or advice on medical aids (including the prescription of medical aids) will be provided. Rehabilitation is planned for 2 to 3 days a week over a period of 4 to 6 weeks. The concept includes a high degree of flexibility in order to meet the individual needs of the participants. Therapies will therefore take place at the participants’ home or at the outpatient centre. The outpatient centre is part of the Department of Rehabilitation and Sports Medicine of a university hospital, where care, research and education are combined in a multiprofessional team.

The physician involved in this project is an experienced physician with more than 30 years of professional experience in various fields within orthopaedics and rehabilitation. The occupational therapist has several years of professional experience in occupational therapy, healthcare and nursing, as well as in the care of intellectual disabilities. The physiotherapist has several years of experience in physiotherapy, especially in the field of multiple and intellectual disabilities, neurology and education.

Rehabilitation staff are in contact with counsellors who are consulted when necessary.

Recruitment, retention and adherence to the intervention

Recruitment of participants started in September 2023 and will end in August 2024. The intervention for the first participant started on 24 October 2023 and the last subject will be able to start the rehabilitation on 2 September 2024. Rehabilitation will take place from 10 October 2023 to 30 September 2024.

Participants with intellectual and/or multiple disabilities will be recruited in a local medical centre for adults with intellectual and/or multiple disabilities. Physicians will inform patients who meet the inclusion criteria and give them a flyer describing the rehabilitation concept. Interested patients can call or email the contact person on the flyer for more information or to make an appointment. In preparation for the first appointment, interested patients are sent information about the study and a consent form (see online supplemental file 3). This step was considered necessary because some patients have an intellectual disability and may need more time to understand the information or to discuss it with their carers or relatives. All the information provided, including the flyer, participation information and consent form, was professionally translated into plain language. All documents can be requested from the corresponding author.

Before or at the first appointment, the research assistant will explain the study to the participant and the participants’ carers by telephone or in person. If the interested patient and the patient’s carers are willing to participate, they will give their written consent using the consent form.

Retention will be reported and dropouts will be documented. Follow-up appointments will be made with the participants and their relatives and carers. Follow-up assessment will take place in the outpatient clinic or at the participant’s home. Adherence and compliance will be recorded and discussed in weekly team meetings. Solutions will also be discussed and documented. The progress of the study will be assessed using a traffic light system where completed work packages will be highlighted green, delayed or not yet started work packages will be highlighted in red, and work packages that are on schedule will be highlighted in yellow.¹⁴ The progress of the study is reviewed on a weekly basis.

Participants

The local medical centres for adults with intellectual and/or multiple disabilities will recruit participants who meet the inclusion criteria. These include having an intellectual and/or multiple disabilities; having a degree of disability of at least 70 (§151 SGB IX), indicated by the Lower Saxony State Office for Social Affairs, Youth and Family; a scale to determine the extent to which a person’s physical, mental or emotional health is impaired is used in Germany. It is known as the ‘degree of disability’ (Grad der Behinderung or GdB). The GdB is expressed in numbers, ranging from 20 to 100, in increments of 10. A GdB 20 implies mild impairments. A GdB 100 indicates very severe impairments. People can apply through their local pension office. The GdB system aims to ensure appropriate support in daily life and having at least one of the codes in the disability pass (Art.56 Nr.1 SGB IX), which include impaired mobility, exceptional walking disability, blindness, deafness, need for constant assistance and additional orthopaedic-neurological diagnosis within the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) codes M00–M99 or G00–G99. The detailed eligibility criteria are shown in table 1.

Table 1. Eligibility criteria for the participants.

Inclusion criteria

Exclusion criteria

Intellectual and/or multiple disabilities within the ICD-10 Codes: E 75, E 76, F 06, F 70.1, F 71, F 72, F 73, F 78, F 80, F 84, G 10, G 12, G 14, G 71, G 80, G 82, Q 00–Q 07, Q 74.3, Q 86, Q 87, Q 90–Q 99; degree of disability of at least 70; at least one of the signs G, aG, BI, GI, H Additional ICD-10 Code M00–M99 and/or G00–G99 Aged 18 years or older All sexes Gives written consent by the patient and, if necessary, the legal carer Relatives and personal carers of the participant with given written consent

Aged under 18 years Not capable to give consent Does not give written consent

ICD-10International Statistical Classification of Diseases and Related Health Problems 10th Revision

As relatives and personal carers are involved in the lives of the patients, they were also included in the study population. Relatives and/or carers of the participants will be interviewed in person or by telephone about their experiences during rehabilitation. Their written informed consent is also required.

For this experimental feasibility study, a small sample size of 15–20 participants is planned for pragmatic reasons. Participants are likely to need more time to prepare for therapy, such as undressing or going to the toilet, and more time to rest between exercises or therapy sessions. In addition, it is not known how many patients with intellectual and/or multiple disabilities will have a need for medical rehabilitation or would be interested in medical rehabilitation.

Global study procedure

The global procedure of the study is shown in table 2 with the timetable of the study phases. During the preparatory phase, the ethical approval, study registration and patient recruitment will take place.

Table 2. Schedule of study phases.

Months	1–3	4–16				17–18
	Preparatory phase	Intervention phase				Evaluation phase
Measuring times	Before baseline	Baseline (T0)	Rehabilitation	After rehabilitation (T1)	1-month follow-up (T2)	After T2
Preparatory phase
Ethical approval	x
Recruitment	x
Eligibility screen	x
Informed consent		x
Intervention phase
Medical consultation		x
Rehabilitative intervention			x
Collecting demographic data		x		x
Questionnaire survey		x		x	x
Interviews					x
Focus group				x
Evaluation
Quantitative evaluation						x
Qualitative evaluation						x

Easy-to-read language

All study documents, including the evaluation questionnaires, have been translated into easy-to-read language. Plain language is used to make information accessible to people with cognitive disabilities or those who have difficulty understanding complex texts. It uses simplified vocabulary, short sentences and clear, straightforward structures to ensure comprehension. The aim of using easy-to-read language is to reduce barriers and ensure that everyone, regardless of their language or cognitive ability, can understand important information.

The translated study documents, including the evaluation questionnaires, were pre-tested on three volunteers with cognitive disabilities before the recruitment of participants began. Volunteers were recruited through the local medical centre for adults with intellectual and/or multiple disabilities.

Adverse events in participants

General risks may occur during the course of the therapies; for example, side effects. Rehabilitation staff are trained to manage side effects and contraindications. They will inform participants about adverse events and adjust the therapy if necessary. Adverse events will be reported in the medical records by the treating therapists. During the rehabilitation and evaluation phase, participants may experience psychosocial stress in addition to time constraints, such as travelling to and from the therapy. It is therefore beneficial to have the participants’ relatives or carers present during the treatment. In order to manage these side effects and psychosocial stress for the participants adequately, the staff members involved in the study will be briefed and will try to keep the psychosocial stress as low as possible.

Data collection

Data will be collected by the research staff at baseline (T0), at the end of rehabilitation (T1) and 1 month after the end of rehabilitation (T2). A detailed schedule of data collection is provided in table 3. Qualitative data, such as interviews, will be recorded as an audio file, transcribed pseudonymously and exported to MAXQDA. Quantitative data, such as demographic and questionnaire data, will be documented and analysed in Excel and SPSS. Sociodemographic data of participants will be collected from medical records, while sociodemographic data of relatives and carers will be collected through a short questionnaire.

Table 3. Schedule of data collection and planned instruments.

Data	Instrument	T0	T1	T2
Primary outcomes
Feasibility in general	Interview and focus group		x
Feasibility of the intervention	Interview with participantsInterview with relatives or carersFocus group with the rehabilitation and administrative team		x
Economic feasibility	income and expenditure analysis		x
Secondary outcomes
Frequency of rehabilitative interventions	Medical records		x
participants’ sociodemographics	Medical records	x
Relatives’ and assistants’ sociodemographics	Short questionnaire for relatives and carers	x
Rehabilitation staff sociodemographics	Short questionnaire for rehabilitation staff		x
Participants’ quality of life and participation targets	Participant’s questionnaire	x	x	x
	Interview with participants		x
	Interview with relatives or carers		x

Data protection and dissemination

Participants will be given an individual identification code.

All data will be collected and analysed pseudonymously, will be treated confidentially according to the guidelines of the Data Protection Act, and will only be used for the purposes of scientific research. Only the researchers will have access to the data collected. After completion of the study, the data will be stored for 10 years in accordance with good scientific practice and protected against unauthorised access by an encryption programme. The data will be irrevocably deleted after 10 years.

The data will be published in non-identifiable form in conference presentations and publications. There are no plans to provide public access to the datasets and statistics. The data monitoring strategy has been approved in consultation with the University Hospital Data Protection Officer.

Primary outcome measure: feasibility measures

The primary outcome of this study is the feasibility of the concept. Organisational and economic feasibility will be assessed.

Organisational feasibility will analyse the human and time resources required for planning and implementing the therapies. Additionally, it will assess the perspectives of the patients and relatives or caregivers. For this purpose, a questionnaire and a guideline-based interview will be used. The questionnaire for participants will be employed to capture individual participation goals and quality of life before and after the intervention. The questionnaire will be based on validated instruments such as the Index for the Assessment of Health Impairments,¹⁵ WHO Quality of Life Brief Questionnaire¹⁶ and the Rehabilitation Goal Setting.¹⁷ Items will be adapted to suit participants with cognitive impairments and translated into plain language. The guideline-based interviews will explore organisational experiences and perceptions of the therapy outcomes from participants, relatives and caregivers. It will also be translated into plain language to ensure accessibility.

The economic feasibility will be analysed with an income and expenditure analysis, focusing on the financial viability of the rehabilitation concept. The planned data and instruments are shown in table 3.

Proposed instruments to evaluate feasibility

To assess the feasibility and quantify its success, the following measures will be applied for organisational feasibility: a comparison of resources required (eg, time, personnel) with standard benchmarks, changes in quality of life and goal achievement measured by before-and-after questionnaires and the thematic analysis of interview data to extract insights into organisational experiences. For economic feasibility, a detailed analysis of income and expenses will help to determine the cost-effectiveness.

By systematically evaluating these dimensions, feasibility will be quantified and key facilitators and barriers will be identified.

Secondary outcome measure: clinical measures

Secondary outcomes aim to capture additional factors related to the intervention’s impact and its broader implications. These include socio-demographic characteristics of all participants, the frequency of medical consultations and the number of therapy prescriptions, adherence rates, as measured by the number of physical and occupational therapy sessions actually performed and the achievement of therapy goals, assessed through a statistical analysis of quantitative data. Photographic and video recording will be used to document the alterations in movements and activities and to evaluate the therapy goals.

Interim analyses will ensure continuous evaluation, allowing for adjustments if necessary. The final study evaluation will occur at the end of the intervention phase, which spans 12 months. Early termination may be considered 1 month before the planned end of the intervention phase, as all participants will have completed the rehabilitation and a newly enrolled participant will not be able to manage the rehabilitation concept within the planned time of 4 to 6 weeks.

Barriers and facilitators to protocol adherence

Recruitment of staff may be difficult due to the shortage of professionals in the therapeutic field. Other potential risks to the conduct of the project include inadequate recruitment of participants and a high dropout rate during the intervention phase. Lack of interest in participating in the interviews could negatively affect the evaluation.

The stated risk factors will be counteracted by providing detailed information to all participants prior to the intervention phase. Feedback on the feasibility process will also be requested from participating rehabilitation staff at weekly team meetings.

The participating rehabilitation staff and researchers will meet weekly to discuss risk factors for poor adherence to the protocol and challenges with the treatments and administration. Independent investigators will not monitor the process.

Analysis

The analysis process will distinguish between primary and secondary outcomes and will be conducted by the researchers. The analysis will start on 1 October 2024.

The primary outcomes are the organisational and economic feasibility as well as the acceptance of the rehabilitation programme by the participants.

Organisational feasibility will primarily be tested by implementing the rehabilitation programme on 15–20 patients during the planned period. The economic feasibility will be analysed by determining whether the rehabilitation services, for example, the therapies, cover the personnel and material costs within the legally prescribed time intervals. Therapies will be accounted for as remedies so that these can be compared with personnel and material costs. Therapy times will be recorded to the minute. The therapists will be instructed to go beyond the legally prescribed time frame if the therapy situation requires it. The organisational and economic feasibility will be evaluated by two researchers.

The acceptability of the intervention will be analysed through interviews with patients and their relatives or carers. Acceptance of the rehabilitation programme will be assessed by two researchers using the content-structuring analysis according to Kuckartz¹⁸ with the MAXQDA software.

Secondary outcomes such as the socio-demographic characteristics of all participants, the frequency of medical consultations, the number of therapy prescriptions, the number of physical and occupational therapies actually performed and the answers given in the questionnaires will be statistically analysed by two researchers using MS Excel and IBM SPSS.

Ethics and dissemination

Ethical approval was granted by the Ethics Committee of Hannover Medical School (reference number: 10985_BO_S_2023). The study was registered in the German Clinical Trials Register.

1. Publication: The results of the project will be made available to the public through open-access publications. We plan to develop a treatment guideline for the treatment concept based on clinical experience.

2. Widespread implementation: If the project is continued and adequately staffed, the rehabilitative care concept could be implemented nationwide and the University Hospital could be available as a reference clinic.

3. Possible continuation: With appropriate funding, the model can be expanded with adjustments based on the experience gained and evaluated in the control group design. The decisive factor for a continuation will be the time required, eg, whether the current billing possibilities in accordance with § 40 (1) Social Code, Book V (mobile rehabilitation) are sufficient.

The documents and data used in the study are available from the corresponding author on request.