Cardiovascular Diseases, Stroke Sequelae
Conditions
Keywords
stroke, stroke sequelae
Brief summary
Stroke is a leading cause of long-term disability and death worldwide, with chronic survivors often experiencing gait disturbances (affecting up to 80%), reduced physical activity, and cardiometabolic comorbidities like obesity and hypertension. These increase risks of recurrent events and diminish quality of life. Electromechanically assisted gait training (EAGT) provides high-intensity, repetitive practice, while conventional gait training (CGT) enhances real-world functional transfer. Evidence gaps exist in the optimal sequencing of these approaches for concurrent improvements in weight management, blood pressure (BP), and mobility, particularly in high-risk chronic stroke populations. This multicenter RCT addresses these gaps by evaluating a sequenced hybrid protocol.
Detailed description
Objectives & Hypotheses Primary Objective: Evaluate the efficacy of sequenced hybrid EAGT followed by CGT compared to EAGT-only or CGT-only in promoting concurrent improvements in body weight, BP, and gait parameters in chronic stroke survivors with overweight/obesity and hypertension. Secondary Objectives: Assess retention of gains at 3-month follow-up; explore mechanistic insights into cardiometabolic loading; identify prognostic factors. Hypotheses: Hybrid sequencing leads to greater weight loss (≥3 kg) and systolic BP reduction (≥10 mmHg) without compromising gait improvements. Obese participants (BMI ≥30 kg/m²) show stronger cardiometabolic responses. Gains are retained better in the hybrid group at follow up
Interventions
already mentioned
Group C (CGT-only)
Sponsors
Study design
Intervention model description
Prospective, assessor-blinded, three-arm parallel-group RCT Allocation: 1:1:1 Duration: 12 weeks intervention + 3-month follow-up (total 6 months) Setting: Five rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care & Rehabilitation Center, Al-Makki Rehabilitation Center, Hashoo Foundation Rehabilitation Center, Model Addiction Treatment & Rehabilitation Centre - Swat, and one additional site).
Eligibility
Inclusion criteria
* Ischemic/hemorrhagic stroke ≥6 months prior * Functional Ambulation Category (FAC) ≥3; BMI ≥25 kg/m²; systolic BP ≥130 mmHg. * able to provide informed consent
Exclusion criteria
* Unstable cardiovascular conditions * Severe cognitive impairment (MMSE \<20) * Other neurological disorders affecting gait * Musculoskeletal issues limiting training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | Baseline, 6 weeks, 12 weeks | 10 meter walk test to measure functional mobility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome | 3-month follow-up | Barthel Index to assess functional independence. |
Countries
Pakistan
Contacts
Taibah University