About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
STEP-Tech intervention
BehavioralStroke 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.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of eligible participants out of screened participants
Total number of participants who pass the screening phase.
Proportion of ineligible participants out of screened participants
The total number of participants who are ineligible and their reasons
Number of participants enrolled
Number of participants enrolled
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.
Secondary outcomes
6-Minute Walk Test (6MWT)
The six-minute walk test measures the distance that a person can walk in six minutes. For individuals with stroke, the six-minute walk test is a validated and recommended rehabilitation outcome measure of aerobic and walking capacity. The score is the distance the patient walks in 6 minutes. Generally, for healthy adults without mobility problems, the typical score is between 1,311 and 2,295 feet. Higher scores indicate better endurance and exercise tolerance.
Five-Times-Sit-To-Stand Test (FTSTS)
The FTSTS measures the time it takes a stroke patient to perform five sit-to-stand repetitions to assess lower-limb muscle strength and balance. The test requires the participant to sit in a chair with their back against the backrest and their arms folded across their chest. Therefore, it is recommended that the chair be 43-46 cm in height and have a straight back. When instructed, the participant should perform the exercise as quickly as possible by standing up fully and then sitting down for five repetitions. The FTSST is a practical, reliable, and affordable tool for evaluating the ability to stand and sit within a short period of time.
Rivermead Mobility Index
There are 15 items on the Rivermead Mobility Index, including 1 direct observation and 14 self-reported items. Items receive a score of 1 if the patient successfully completes the task, or 0 if they are unable to do so. A maximum score of 15 is then obtained by adding the points; higher scores indicate greater functional mobility.
The indicator of gait quality (The number of recorded steps)
The number of recorded steps obtained from the Heel2Toe sensor during the 6-Minute Walk Test (6MWT). Unit: steps
Sponsors and contacts
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University of Exeter
Lead sponsor
Najran University
Collaborator
Prince Sultan Bin Abdulaziz Humanitarian City
Collaborator
Aseer Central Hospital
Collaborator
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