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. 2021 Jul 5;12:675106. doi: 10.3389/fneur.2021.675106

Table 1.

Protocol for the textured insole group (based on the Template for Intervention Description and Replication, TIDieR checklist).

1 Name: Textured insole (TI) protocol for TI group
2 Rationale: The plantar (sole of the foot) mechanoreceptors are key, sending information to the CNS; plantar stimulation has been shown to result in increased control of body sway (47). In view of the importance of cutaneous information from the plantar surface of the foot to control balance (48), other potential mechanisms of increasing plantar stimulation have been explored. TIs improve postural control in standing in healthy participants (49), walking patterns for people with multiple sclerosis (25). However, the combination of wearing TIs and task-specific gait training (TSGT) has not been evaluated to determine the benefits for balance and walking recovery early after stroke. The use of TIs in the shoes of stroke survivors involves a hands-off (therapist independent) approach, which may potentially be a more economical option for achieving increased sensory stimulation to the foot and is, therefore, important to investigate.
3 Materials: Smooth and TIs will be patient specific and cut to size so they fit in the participant's shoe. Both insoles are manufactured by Algeos UK Ltd., Liverpool, UK. The smooth surface will be of medium density EVA, 3 mm thickness, Shore value A50, black, OG1304. The TI has small, pyramidal peaks with centre-to-centre distances of ~2.5 mm Evalite Pyramid EVA, 3 mm thickness, Shore value A50, black, OG1549.
4 Procedures: This group of participants will be encouraged to wear the TI on the contralesional side (and a smooth insole the opposite side), as much as possible (to “augment” the sensorimotor system), during the 4–6-week intervention period, except when the outcomes are being assessed. In addition to wearing the TIs participants will also receive 20 sessions of TSGT (30 min each session), during the intervention period. The specific content of each treatment session will be documented; daily diaries will inform the research team of the extent of wearing of the TIs. Outcome measures will be undertaken without the participant wearing TIs, so it is the same conditions as the mobilization and tactile stimulation group, which is the other arm of the trial.
5 Provided by: Participant is responsible for wearing textured/smooth insoles. If help is needed to put TIs into shoes and put on footwear (and no family support is available), a Research Therapist will assist, prior to TSGT.
6 Mode of delivery: Participant controlled—wearing the TIs for as much as possible during the 4–6-week intervention period. The Research Therapist will help if required to put the TIs into shoes and put on footwear prior to TSGT if required. The participant will, therefore, wear the TIs a minimum of 30 min 4–5 times per week.
7 Location: The participants will be encouraged to wear the TIs and receive the TSGT in their own environment, whether this is as an inpatient or their own home.
8 When and how much: Time wearing the insoles will vary. Some participants may just wear them during the TSGT and others may wear them for long periods in the day. Participants will be encouraged to record the length of time insoles are worn on the daily diaries.
9 Tailoring: The participant is in control of time wearing insoles, tailoring intervention to their comfort and needs.
10 Modifications: Any modifications to the TI protocol will be recorded.
11 Intervention adherence and fidelity: Planning: Intervention adherence and fidelity will be assessed. Strategies to improve fidelity and adherence include: research therapist training, encouragement and motivation regarding wearing of TIs by the research therapist delivering the TSGT and the keeping of daily diaries which will be collected weekly. A record of the length of time wearing the insoles will be included as a prompt in the simple diaries and this information will enable monitoring of adherence and fidelity. The information from the daily diaries will be analysed by the Chief Investigator, with additional guidance from the research team.
12 Intervention adherence and fidelity: How well, actual: The analysis of the daily diary sheets will give an indication of adherence to the intervention. The focus groups will enable further opportunity of assessing the adherence, fidelity and acceptability of the intervention.

TI, Textured insole; TSGT, Task-specific gait training.