The Feasibility and Acceptability of a Gait Training Program Based on Telerehabilitation After Stroke

NCT07623018 | Not Yet Recruiting DMC

• 1 other identifier: 10444866
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

Gait impairments following stroke significantly reduce functional mobility, making walking recovery a primary rehabilitation goal to improve safety, speed, and quality of life while reducing fall risk. Delivering interventions at home via technology can enhance adherence to home exercise programmes and increase therapy frequency and intensity. This study aims to determine the feasibility and acceptability of the Stroke Telerehabilitation for Enhanced Performance in Gait via Technology (STEP-Tech) intervention for patients with stroke in Saudi Arabia. The intervention will be delivered by trained physiotherapists in two phases. Phase one will take place in an outpatient setting, during which patients may require approximately three sessions over one week. Phase two will be home-based for four weeks.

Conditions

Stroke

Keywords

stroke; Telerehabilitation; Gait; Feasibility study

Outcome Measures

Primary Outcomes (7)

• Proportion of eligible participants out of screened participants

  Total number of participants who pass the screening phase.

  During the screening process

• Proportion of ineligible participants out of screened participants

  The total number of participants who are ineligible and their reasons

  During the screening process

• Number of participants enrolled

  Number of participants enrolled

  During the enrolment process

• Retention rate

  Retention rate is defined as the proportion of people who finished the intervention program after 5 weeks. Retention rate will be assessed based on A) the number of participants who discontinued and the reasons. B) proportion of participants with complete outcome assessment. Data will be collected by using a screening log.

  Recorded at week 6

• Safety of intervention (any adverse events recorded)

  Adverse events are any unfavourable experiences that participants describe during the study, regardless of whether they were related to the intervention. Participants will be asked to report any adverse effects to their physiotherapist during the weekly follow-up sessions.

  During intervention period (5 weeks)

• Fidelity of intervention delivery

  Physiotherapists will receive face-to-face training sessions on intervention delivery to ensure they have sufficient knowledge and skills to provide interventions to patients after stroke. To further enhance their skills, the P.I. will observe the first intervention session they deliver with every patient in the clinic and complete a checklist covering all intervention components to confirm fidelity. Patients' understanding of how to undertake the key intervention component at home will be checked by a physiotherapist during face-to-face sessions in the first week (phase 1) using a checklist for each participant.

  During intervention period (5 weeks)

• Adherence rate

  Patients' adherence during phase 1(adherence to attend the face-to-face sessions in the clinic) will be evaluate through the attendance form. Exercise adherence will be assessed through self-completed exercise logs and documentation obtained from a weekly follow-up session.

  During intervention period (5 weeks)

Secondary Outcomes (17)

• 6-Minute Walk Test (6MWT)

  at baseline (pre-intervention) and immediately after the intervention (at week 6).

• Five-Times-Sit-To-Stand Test (FTSTS)

  at baseline (pre-intervention) and immediately after the intervention (at week 6)

• Rivermead Mobility Index

  at baseline (pre-intervention) and immediately after the intervention (at week 6).

• The indicator of gait quality (The number of recorded steps)

  at baseline (pre-intervention) and immediately after the intervention (at week 6).

• The indicator of gait quality (Number of good steps)

  at baseline (pre-intervention) and immediately after the intervention (at week 6)

Study Arms (1)

Participant group

EXPERIMENTAL

The experimental group will receive STEP-Tech intervention to enhance gait quality, adherence and engagement to exercises at home, addressing all identified Behaviour Change Techniques (BCTs).

Behavioral: STEP-Tech intervention

Interventions

STEP-Tech intervention BEHAVIORAL

Stroke telerehabilitation for Enhanced Performance in Gait via technology (STEP-Tech) intervention was developed by the research team, using the UK Medical Research Council (MRC) framework for developing and evaluating complex interventions. The STEP-Tech intervention has 4 components: 1) Gait training using the Heel2Toe sensor. 2) A set of exercises that aim to enhance LL strengthening, stretching, balance and gait tasks. 3)Education. 4)Family and caregiver support. The STEP-Tech intervention will be delivered in a hybrid model in two phases. Phase 1 (preparatory phase): In-person in the outpatient department. Patients may require approximately three sessions with a physiotherapist over one week. Phase 2 (Home-based): Patients with stroke will be instructed to practise walking with the Heel2Toe sensor for a minimum of 5 minutes, twice a day, for four weeks.

Participant group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For stage one of the study:
• People with stroke aged \> 18 years living in Saudi Arabia.
• Diagnosed with ischemic or haemorrhagic stroke.
• People with stroke in the late-subacute or chronic phase ( ≥ 3 months after stroke onset).
• Patients can walk indoors for at least 10 meters with supervision and/or an assistive device (cane or walker).
• Patient with low fall risk (less than 20 seconds) based on the Timed Up and Go test (TUG).
• Ability to understand instructions and follow simple commands to participate in the study and give consent. Patients are required to obtain a score of seven or eight on the eight decisional capacity questionnaires that are relevant to the consent form content. These requirements are necessary to make sure that people can give consent. The decisional capacity questionnaire's content is based on the previously utilised University of California Brief Assessment Capacity to Consent (UBACC) questions that have been adjusted for the study's context.
• They are not currently participating in any other stroke rehabilitation study.
• Only those who can speak Arabic or English.
• For stage 2 of the study (qualitative evaluation):
• Physiotherapists with experience working with people who have had a stroke (at least 2 years of experience).
• Carers aged 18 years or older who support patients during the intervention period
• Able to communicate in Arabic or English

You may not qualify if:

• For stage one of the study :
• Patient with severe spasticity and contracture in the lower extremity (Modified Ashworth Scale 3 or 4).
• Unable to understand instructions to participate in the study and to give consent (due to severe cognitive impairments).
• Severe communication deficit or complete aphasia.
• Patients have another neurological condition (e.g., multiple sclerosis or Parkinson's disease) or a pre-stroke health condition that includes a gait disorder.
• Serious medical comorbidities such as pulmonary and heart disease, and uncontrolled hypertension.
• For stage 2 of the study (qualitative evaluation):
• Physiotherapists with insufficient experience (less than 2 years' experience) in stroke rehabilitation.
• Carers who are unable to communicate well or have communication difficulties.
• Carers who are unable to give consent.

Sponsors & Collaborators

• University of Exeter: lead
• Prince Sultan Bin Abdulaziz Humanitarian City: collaborator
• Aseer Central Hospital: collaborator
• Najran University: collaborator

Study Sites (2)

Aseer Rehabilitation Centre

Abhā, Southern Region, Saudi Arabia

Location

Sultan Bin Abdulaziz Humanitarian City (SBAHC)

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Bayan Alwadai, PhD researcher

CONTACT

07432573265; ba447@exeter.ac.uk

Helen Dawes, Professor

CONTACT

07934675772; H.Dawes@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)