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NCT07623018

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

Sponsor: University of Exeter

View on ClinicalTrials.gov

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.

Official title: What is the Feasibility and Patient Acceptability of a Gait Training Program Based on Telerehabilitation After Stroke? A Mixed-methods, Single-arm Feasibility Study of the (STEP-Tech) Intervention

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-08-01

Completion Date

2028-08-01

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Stroke

Interventions

BEHAVIORAL

STEP-Tech intervention

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.

Inclusion Criteria: 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 Exclusion Criteria: 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.

Locations (2)

Aseer Rehabilitation Centre

Abhā, Southern Region, Saudi Arabia

Sultan Bin Abdulaziz Humanitarian City (SBAHC)

Riyadh, Saudi Arabia