Abstract
Background
After stroke, most patients have impairments in trunk control, balance, and gait. These dysfunctions are closely related to the ability to perform activities of daily living. Therefore, restoring these functions has become the primary rehabilitation goal for stroke patients. Lumbar joint mobilization can activate the spine and surrounding muscles, increase the sensory perception of lumbar joints, restore the stability and symmetry of the trunk. Few studies have focused on the use of lumbar joint mobilization in stroke patients. The purpose of this study was to explore the effects of lumbar joint mobilization on trunk control, balance, and gait in stroke patients.
Methods
Sixty stroke patients will be recruited from the Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The participants will be randomly divided into a control group (n = 30) and an intervention group (n = 30). Both groups will receive conventional physical therapy once a day for 4 weeks, 5 days a week. The intervention group will receive an additional 10 min of lumbar joint mobilization at the end of each conventional physical therapy session. The primary outcome measure is the Trunk Impairment Scale (TIS), the secondary outcome measures are Berg Balance Scale (BBS), Time Up & Go test (TUG) and Functional Gait Assessment (FGA). Patients will be assessed for the outcome measures at baseline and at the 4th week at the end of treatment.
Discussion
The results of this study will provide preliminary data on the efficacy of lumbar joint mobilization combined with conventional physical therapy on trunk control, balance, and gait in stroke patients.
Trial registration
The trial was registered in the Chinese Clinical Trial Registry on September 3, 2023, with the registration number ChiCTR2300075377. The URL of trial registry record: https://www.chictr.org.cn/showproj.html?proj=206313.
Supplementary Information
The online version contains supplementary material available at 10.1186/s13063-025-08767-0.
Keywords: Lumbar spine, Joint mobilization, Trunk control, Balance, Gait and stroke patient
Background
Approximately 15 million new stroke patients are reported worldwide each year, with one-third of these patients experiencing permanent physical dysfunction. Stroke patients commonly experience diminished proprioception of the joint position due to muscle contractures and weakness, leading to limited trunk movement and impaired control [1]. Limited trunk control contributes to decreased balance [2] and walking ability [3]. Dysfunction of trunk control, balance, and gait are major functional impairments in stroke patients and are manifested as decreased ability to perform activities of daily living and social participation activities. Thus, restoring trunk control, balance and gait is a vital priority when considering poststroke rehabilitation plans.
After stroke, the pontine reticulospinal tract, which is responsible for controlling postural stability and walking function, becomes inactive due to damage to the central nerve conduction pathway. As a result, stroke patients commonly experience reduced trunk control and walking ability [4–6]. Additionally, they may exhibit specific limitations in trunk flexion, lateral flexion, and rotation muscle strength [7]. Limitation of trunk movement can lead to decreased proprioception of spinal joints in stroke patients [8]. To address this issue, it is necessary to implement proprioceptive stimulation techniques targeting the trunk. These interventions aim to improve the movement of spinal joints, activate the muscles of lumbar segments (such as the multifidus, transversus abdominis, and internal and external oblique muscles), and ultimately activate the pontine reticulospinal tract.
Joint mobilization is a passive manipulative technique that is performed by a physical therapist to improve physiological or accessory movements of joints, promote joint mobility and aid in proprioception recovery. Joint mobilization is primarily used in patients with musculoskeletal injuries and patients with severe central nervous system injuries accompanied by joint disorders or musculoskeletal disorders, including degeneration of joints and stiffness of tissue around joints [9]. Studies have indicated that lumbar joint mobilization can enhance the sense of position in lumbar spine joints, activate the paraspinal muscles, and improve muscle weakness, muscle tone and joint stiffness [10].
While lumbar joint mobilization shows promise as a beneficial technique for stroke rehabilitation, particularly in improving trunk control and balance, much remains to be explored. In South Korea, lumbar joint mobilization with physical therapy shows promise for improving trunk control in stroke patients. Larger studies, especially on chronic cases, are needed to confirm its effectiveness and safety [11]. In the U.S., lumbar joint mobilization is mostly used for low back pain, with limited stroke studies. Small trials show benefits for postural stability, but large RCTs are needed to confirm its effectiveness [12]. In Europe, lumbar mobilization is used in stroke rehab to improve postural symmetry and reduce stiffness, though not widely. Larger, multicenter trials are needed to assess safety and combined therapy effects [13]. To move the field forward, large-scale RCTs, and further studies on functional outcomes and adverse events are essential. By addressing these gaps, lumbar joint mobilization may become an important component of stroke rehabilitation worldwide.
Based on the above studies, we designed a large-scale RCTs and hypothesize that lumbar joint mobilization could improve trunk control, balance function and gait in stroke patients. The aim of this study was to investigate the hypothesis that lumbar joint mobilization can improve trunk control, balance function and gait in stroke patients. The outcome measurements included the Trunk Impairment Scale (TIS), the Berg Balance Scale (BBS), the Time Up & Go (TUG) test and the Functional Gait Assessment (FGA).
Methods/design
Study design
The study will be a single-blind (the assessor will be blinded) randomized controlled superiority trial with two parallel groups. The study protocol will comply with the Declaration of Helsinki and will be conducted in accordance with the standard protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and the World Health Organization Trial Registry Data set (version 1.2.1) guidelines for clinical trial protocols (see File 1 and 2). This study will be conducted in the Department of Rehabilitation Medicine, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China. All the subjects were diagnosed with stroke according to the diagnostic criteria for major cerebrovascular diseases in China (2019) formulated by the Chinese Society of Neurology and confirmed by CT or MRI. To recruit more subjects, we will leverage multiple recruitment channels, eg hospital and clinic partnerships, other physician referrals. In addition, we will enhance outreach and awareness by posting study-related advertisements. A flowchart is shown in Fig. 1.
Fig. 1.
The flowchart for this trial
Eligibility
The inclusion criteria will be as follows:
① Course of disease ≥ 6 months;
② Age ≤ 75 years;
③ MMSE score > 24 points;
④ Able to walk independently for at least 10 m;
⑤ Her daily blood pressure did not exceed 140/90 mmHg (or was under medication control).
The exclusion criteria will be as follows:
① Severe heart and lung disease or liver and kidney dysfunction;
② Severe bone or joint diseases, especially of the spine;
③ Accompanied by visual, language, vestibular or auditory disorders;
④ Comorbidities with other neurological diseases, such as Parkinson’s disease;
⑤ There are risk factors for osteoporosis, especially in the spine.
All the patients met the inclusion criteria are signatured the informed consent (see File 3) before the study began. Ruidi Wu is responsible for obtaining informed consent.
Randomization and blinding
The patients will be randomly divided into an intervention group and a control group at a ratio of 1:1. Yong Chen will use SPSS to generate random numbers to create random allocation cards, which will be sealed with opaque envelopes. The enrolled participants will be divided into groups based on the card numbers found in the sealed envelopes which Hong Chen is responsible for this task, and the subjects will receive treatment accordingly within their respective groups. Given the inherent characteristics of the interventions, it is not feasible to blind the therapists and subjects to the specific type of intervention. However, to maintain the integrity of the study, efforts will be made to maintain blinding among the assessors and statisticians regarding the allocation results. To achieve this, assessments will be conducted in a designated separate room to minimize the possibility of assessors becoming aware of the trial group assignments during the assessment process. Additionally, the statisticians involved in the study will be kept unaware of both the identity of the subjects and their trial group assignments. These measures will be implemented to mitigate potential biases and ensure the objectivity and impartiality of the assessment and statistical analysis procedures. The treatment schedule and outcome assessments are shown in Fig. 2.
Fig. 2.
Schedule of enrolment, interventions, and assessments throughout the trial. CPT Conventional physical therapy, TIS Trunk impairment scale, BBS Berg balance scale, TUG Time up and go test, FGA Functional gait assessment
Intervention
The therapists responsible for administering the treatment to the subjects possess a minimum of five years of clinical work experience. The subjects will be divided into two groups: the intervention group (n = 30) and the control group (n = 30).
The intervention group will receive a combination of conventional physical therapy (CPT) and lumbar joint mobilization, whereas the control group will receive CPT alone. The CPT comprises a comprehensive range of interventions, including range of motion exercises, stretching, muscle strengthening, and functional activity training. Functional activity training includes roll-over in bed training, transitioning from lying to sitting (sit-up in bed), transitioning from sitting to standing (sit-to-stand), and gait training. All patients will undergo a standardized treatment protocol consisting of routine sessions lasting 40 min, administered once a day, five days a week, for a total duration of four weeks.
After receiving CPT, the intervention group will additionally receive the Maitland joint mobilization technique, which will be performed by a separate physical therapist who will not be involved in delivering CPT. The targeted treatment sites for the Maitland joint mobilization technique are the spinous processes of the L1-L5 vertebrae. The technique involves applying a grade III posterior-anterior mobilization force. Each lumbar segment will receive a 2-min mobilization, resulting in a total treatment duration of 10 min. All the Maitland joint mobilization techniques utilized in this study will be applied based on the principles and methods described in chapter 12 of Maitland's book on vertebral manipulation. Figure 3 provides an overview of the Maitland joint mobilization in our study. If the subject experienced any discomfort during the treatment, the treatment was stopped immediately.
Fig. 3.
Lumbar joint mobilization
Participants in both the intervention and control groups will not receive any additional physical therapy, occupational therapy, or other structured rehabilitation interventions during the trial period to minimize potential confounding factors. Standard care, including medical treatment for stroke-related conditions (e.g., anticoagulants, antihypertensive agents), was allowed and recorded, provided that these treatments were consistent between groups and did not interfere with the study interventions.
Plans for participant retention
To ensure high retention rates, several strategies will be implemented:
① Frequent communication: Regular communication with participants will be maintained to address any concerns, ensure clarity of the intervention schedule, and provide encouragement.
② Flexible scheduling: Participants will have the option to schedule therapy sessions at times that are convenient for them, minimizing disruption to their daily routines.
③ Involvement of family members or caregivers: Family members or caregivers will be encouraged to accompany participants or stay engaged throughout the study. Their involvement can provide logistical and emotional support, improving adherence.
④Incentives: Both monetary and non-monetary incentives (e.g., transportation allowances or small tokens of appreciation) will be provided to acknowledge participants’ time and effort.
⑤ Minimizing participant burden: The duration and frequency of assessments will be limited to avoid fatigue, focusing only on critical outcome measures.
⑥ Supportive rapport: Study staff will foster a welcoming and supportive environment, ensuring participants feel valued and motivated to continue.
By implementing these measures, we aim to minimize dropout rates and maintain the integrity of the study.
Assessment
Age, sex, weight, height, stroke type, side of hemiplegia (left or right), and disease course will be recorded at the beginning of the experiment. The primary outcome measurements were the changes in trunk control function, balance function, and gait after 4 weeks of treatment. We will use the trunk impairment scale (TIS) to evaluate trunk control. Changes in balance function will be assessed using the Berg balance scale (BBS). The Time Up & Go Test (TUG) and the Functional Gait Assessment (FGA) will be employed to evaluate changes in gait. The primary outcome is the improvement in trunk control, as assessed by the Trunk Impairment Scale (TIS). Balance (Berg Balance Scale, BBS) and gait (Time Up & Go test, TUG, and Functional Gait Assessment, FGA) are secondary outcomes.
Primary outcome
Trunk impairment scale (TIS)
The TIS is a widely used assessment tool designed to measure motor impairment of the trunk following a stroke. The scale consists of 3 components: static sitting balance (TIS-S, 3 items), dynamic sitting balance (TIS-D, 10 items) and coordination (TIS-C, 4 items). The total TIS ranges from 0 to 23, with higher scores indicating better performance and improved trunk control. The test–retest reliability and interrater reliability for the total TIS score are 0.87–0.96 and 0.85, respectively [14].
Secondary outcomes
Berg balance scale (BBS)
The BBS is a validated assessment tool specifically designed to measure the balance of older adults or patients with neurological impairments. It consists of 14 items that evaluate different aspects of balance. The total score on the BBS ranges from 0 to 56, with higher scores indicating better balance performance. The BBS shows excellent reliability, with a test–retest score of 0.92 and an interrater score of 0.97, indicating strong consistency and agreement in assessing balance [15].
Time Up and Go Test (TUG)
The TUG test is utilized to measure the duration it takes for participants to perform a series of tasks, including rising from a chair, walking a distance of 3 m, turning back around, walking back to the chair, and sitting down. The average of three trials will be utilized for analysis. The test–retest reliability and interrater reliability scores for the TUG test are also high, with values of 0.99 and 0.98, respectively [16].
Functional Gait Assessment (FGA)
The FGA is a four-point scale consisting of 10 evaluation items. A higher score corresponds to better walking ability. The scale is a highly reliable tool used to evaluate functional walking ability, with a correlation coefficient (r) of 0.93 [17].
Adverse events
Prolonged periods of being in a prone position during a 10-min joint mobilization session may have an impact on cardiopulmonary function, potentially resulting in symptoms such as restricted breathing and chest tightness. Preventative measures: ① Implementing a 1-min rest period between each segment of posterior-anterior lumbar joint mobilization. This means that after mobilizing the L1 segment, the subject will have a one-minute break (either by turning over or sitting up) before proceeding to mobilize the L2 segment, and this same pattern will be followed for mobilizing the remaining segments. ② Utilizing a professional PT treatment bed that allows for the removal of the head pillow, creating an unobstructed space for the subject's face. This promotes optimal breathing and reduces the likelihood of chest tightness or discomfort while in the prone position.
Patients may fall during the TIS, BBS, TUG, and FGA assessments. Preventative measures: ① Thoroughly explain the purpose of the assessment, the steps involved, and any precautions to the patients in a detailed manner, ensuring that they have a clear understanding of the entire evaluation process. ② To ensure patient’s safety, one family member or physical therapist will be present to protect the patient during the entire evaluation.
If the participant experiences pain, breathing difficulty, chest tightness, or any other potential discomfort that may be related to the treatment, they also need to contact the therapist. If the discomfort does not subside within 24 h after the treatment, the joint mobilization technique should be stopped. Any adverse events observed will be recorded and reported to the supervising ethics committee, regardless of their severity. In addition, the potentially adverse events that are predictable in this trial (such as breathing difficulty, pain, or chest tightness) and the unpredictable effects on the participant's health will be reported in future publications in an honest manner.
Sample size estimation
Sample size estimation was performed using G*Power 3.1.9.7 software (Heinrich Heine-Universität, Düsseldorf, Germany). Referring to a previous study from Wonjae Choi et al. [11], we set the effect size at 0.8, with a power of 0.8 and a significance level of 0.05. Taking into account a potential dropout rate of less than 20%, we calculated that a total sample size of 60 participants was required to meet the statistical requirements.
Data collection, data management, and statistical analysis
All the data will be double-entered into EpiData 3.1 software (EpiData Association, Odense, Denmark) and then transferred to SPSS 23.0 (IBM, Armonk, NY, USA) for analysis. The significance level alpha will be set at 0.05. One statistician who is blinded to the allocation results will analyse all the data. General characteristics will be evaluated for homogeneity using the chi-square test and independent sample t test. Within-group comparisons will be analysed using paired t tests, while between-group comparisons will be conducted using independent sample t tests for normally distributed data and Mann‒Whitney U tests for nonnormally distributed data. Our trial will employ an intention-to-treat (ITT) approach for the primary analysis. All participants who are randomized into the study will be analyzed in the group to which they were originally assigned, regardless of their adherence to the intervention, protocol deviations, or withdrawal from the study. To handle missing data, sensitivity analysis and weighted estimation equations will be used as the main methods [18] to preserve the integrity of the ITT principle. This approach ensures that the results reflect real-world effectiveness and maintain the validity of the randomization process.
Monitoring and auditing
The monitoring committee, which consists of a physician, two physiotherapists, two assessors and a statistician, will review all the data and potentially audit the trial at any time. The monitoring committee will be independent of the sponsor and will have no conflicts of interest. Additionally, an independent monitoring committee (ISC) at our institution will be responsible for overseeing the progress of the trial and ensuring the quality of the data. The ISC consists of an independent chair and a minimum of six members, including clinical experts, statisticians, patients and representatives from public engagement. All the data will be securely stored in EpiData software.
Interim analysis
The statistician will perform an interim analysis once 60 subjects have completed the experiment. To maintain the cumulative type I error rate at the planned level of 0.05, we use the Lan-Demets spending function approach [19] with an O’Brien-Fleming spending function [20]. The predetermined P value for terminating the trial based on efficacy will be set at 0.00305. Our research team will discuss the results of this interim analysis with the ISC and monitoring committee to determine whether it is appropriate to halt the trial early. In addition, our trial will be stopped if a serious adverse event occurs.
Confidentiality
Each subject will be assigned a unique trial number that cannot be used to identify them personally, which ensures that the data collected during the trial remain confidential and anonymous. Access to the final data will be restricted only to the designated trial investigators, who are authorized to handle and analyse the data.
Access to data
Only the principal investigators had access to the final trial data set. Anonymized data will be delegated to a statistician during and after the trial.
Ancillary and posttrial care
After completion of the trial, we will continue to provide follow-up for all subjects and provide necessary physiotherapy advice if needed.
Dissemination policy
The final results of this study will be published in a scientific journal and will be disseminated at relevant international conferences. We will report our study in accordance with the 2010 updated CONSORT statement guidelines. Key members of the research team will be named coauthors on all relevant publications. We do not intend to use any outside professional writers for publication.
Discussion
The lumbar, pelvic and hip joints are crucial anatomical structures within the human body whose regulation is primarily orchestrated by the ventromedial pontine reticulospinal tract of the brain [21]. This regulatory mechanism occurs in an ipsilateral and non-crossed manner. According to Bobath’s theory, damage to the pontine reticulospinal tract leads to impaired continuous and effective contraction of the core muscle group. This, in turn, results in muscle weakness in the trunk and pelvis, posing challenges in maintaining stable anti-gravity postures during exercise. Consequently, a decrease in trunk control and compromised walking function ensued [22]. Lumbar joint mobilization can improve limited joint movement in the spine [23, 24] and enhance joint perception in the lumbar spine [25, 26]. In addition, lumbar joint mobilization can activate deep lumbar muscles, such as the erector spinae and multifidus. The deep lumbar muscles are very important for maintaining spinal stability [27–29]. Therefore, lumbar joint mobilization can improve the joint movement of the lumbar spine, enhance the proprioceptive input of the lumbar spine, activate the core muscle group, and activate the pontine reticulospinal system, ultimately improving trunk control, balance function and gait in stroke patients.
Based on the above theory and with reference to previous studies, we designed this randomized controlled superiority trial to investigate the effects of 4 weeks of posterior-anterior lumbar joint mobilization on trunk control, balance, and gait in stroke patients. Our intended hypothesis is that 4 weeks of conventional rehabilitation combined with additional lumbar joint mobilization can improve trunk control, balance, and gait in stroke patients.
The implications of this study
The practical implications of this study are extensive and profound. For society, this research has the potential to enhance outcomes for stroke survivors, promote functional independence, and alleviate the burden of long-term disability. For healthcare professionals, it presents a potentially valuable tool to enhance patient care by providing a more comprehensive approach to stroke rehabilitation. Lastly, for the healthcare system, lumbar joint mobilization can result in cost savings, improved resource allocation, enhanced patient outcomes, as well as more efficient and accessible stroke rehabilitation services. By establishing the foundation for larger studies and clinical applications, this study holds the potential to shape the future of rehabilitation care for stroke survivors worldwide.
Limitations of the study
The design of the trial is not double-blinded, which can introduce certain potential biases. For efficacy, we selected only a 4-week duration to assess efficacy. In addition, we have no follow-up or follow-up plans. These factors may limit the ability to capture long-term effects and evaluate the stability of the observed improvements. To minimize confounding effects, we restricted participants from receiving concomitant rehabilitation therapies during the trial. However, standard medical care was permitted, and any potential interactions between medications and rehabilitation outcomes should be interpreted cautiously.
Trial status
The trial is currently recruiting participants. This is protocol version 2.0; the protocol version date is August 8, 2023. Subject recruitment began on September 4, 2023, and will end on September 1, 2024.
Supplementary Information
Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.
Additional file 2. The items from the World Health Organization Trial Registration Data Set.
Additional file 3. Informed consent form.
Acknowledgements
Not applicable.
Abbreviations
- TIS
Trunk impairment scale
- BBS
Berg balance scale
- TUG
Time Up & Go
- FGA
Functional gait assessment
- RCT
Randomized controlled trial
- SPIRIT
Standard Protocol Items Recommendations for Interventional Trials
- CPT
Conventional physical therapy
- ISC
Independent Supervisory Committee
- CONSORT
Consolidated standards of reporting trials
Authors’ contributions
XLF, CC, BY, WRD, HXH and SH conceived of and designed the study protocol. CC and XLF wrote this report. XLF is the corresponding author and supervisor of the research. BY will perform lumbar joint mobilization. CC will perform conventional physical therapy. SH will carry out the statistical analyses. All of the authors reviewed the study protocol and approved this report.
Funding
No funding support, self-financing.
Data availability
The data and materials will not be publicly available until they are published in a peer-reviewed international journal. After publication, the principal investigator obtained the final trial data set by email upon reasonable request.
Declarations
Ethics approval and consent to participate
The study protocol and informed consent were approved by the Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (approval no. TJ-IRB20230897).
Any amendment to the trial protocol will require the approval of the ethics committee. All the subjects signed an informed consent form.
Consent for publication
Written informed consent will be obtained from the patient to publish her personal details and images in this article. Consent forms are held by the authors and will be available upon request.
Competing interests
The authors declare that they have no conflicts of interest.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.
Additional file 2. The items from the World Health Organization Trial Registration Data Set.
Additional file 3. Informed consent form.
Data Availability Statement
The data and materials will not be publicly available until they are published in a peer-reviewed international journal. After publication, the principal investigator obtained the final trial data set by email upon reasonable request.