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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Hybrid: EAGT → CGT) | Active Comparator | Weeks 1-6: EAGT (exoskeleton/end-effector devices; 30- 50% body-weight support, speed 1.5-2 km/h, ≥800-1200 steps/session). Weeks 7-12: CGT (overground walking, obstacles, stairs, dual-tasks). |
|
| Group B (EAGT-only): | Active Comparator | Full 12 weeks EAGT, progressing parameters for intensity. |
|
| Group C (CGT-only) | Active Comparator | Full 12 weeks CGT, progressing complexity and demands. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weeks 1-6: EAGT (exoskeleton/end-effector devices; 30- 50% body-weight support, speed 1.5-2 km/h, ≥800-1200 steps/session). Weeks 7-12: CGT (overground walking, obstacles, stairs, dual-tasks). | Other | already mentioned |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | 10 meter walk test to measure functional mobility | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome | Barthel Index to assess functional independence. | 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Abdullah Alhammad | Taibah University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IQRA National University | Swat | Peshawar | Pakistan |
due to ethical considerations as per ethical approval document
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2022 | Feb 11, 2026 |
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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).
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|
| Full 12 weeks CGT, progressing complexity and demands. | Other | Group C (CGT-only) |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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