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

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Exeter

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Participant groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of eligible participants out of screened participants

Total number of participants who pass the screening phase.

Time frame
During the screening process
2

Proportion of ineligible participants out of screened participants

The total number of participants who are ineligible and their reasons

Time frame
During the screening process
3

Number of participants enrolled

Number of participants enrolled

Time frame
During the enrolment process
4

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.

Time frame
Recorded at week 6

Secondary outcomes

1

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.

Time frame
at baseline (pre-intervention) and immediately after the intervention (at week 6).
2

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.

Time frame
at baseline (pre-intervention) and immediately after the intervention (at week 6)
3

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.

Time frame
at baseline (pre-intervention) and immediately after the intervention (at week 6).
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Exeter

Lead sponsor

Najran University

Collaborator

Prince Sultan Bin Abdulaziz Humanitarian City

Collaborator

Aseer Central Hospital

Collaborator

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