Sequenced Hybrid Electromechanically Assisted and Conventional Gait Training for Concurrent Optimization of Weight Management, Blood Pressure Regulation, and Functional Mobility in Chronic Stroke Survivors: A Multicenter RCT
Phase: NA
Conditions: Cardiovascular Diseases, Stroke Sequelae
Sponsor: Iqra National University

 
Ref#: INU/REHAB/XC108 Date: 25/010/2022  
Study Protocol Sequenced Hybrid Electromechanically Assisted and Conventional Gait Training  
for Concurrent Optimization of Weight Management, Blood Pressure Regulation, and Functional  
Mobility in Chronic Stroke Survivors: A Multicenter Randomized Controlled Trial  
December 2025 (pre-trial approval) Principal Investigator: Muslim Khan, Associate Professor,  
Faculty of Rehabilitation Sciences, IQRA National University, Swat, Pakistan   
Co-Investigators: Ayman Abdullah Alhammad, Mshari Alghadier, Saeed Mufleh Alnasser,  
Abdullah Basheer Alanazi, Hasan Ali Abdullah AlAidarous, Engy BadrEldin Saleh Moustafa,  
Ibrahim Abuzaid, Abdulmajeed R. Almalty (affiliations as listed in main manuscript)  
Ethical Approval: Obtained from institutional review boards of all participating centers  
Registration: https://doi.org/10.6084/m9.figshare.30983740 Data   
OSF Reg https://osf.io/bf3jd/overview  
Preprint https://osf.io/preprints/mediarxiv/hm8ze_v1  
Funding: Institutional resources only; no external funding  
1. Background & Rationale 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.  
2. 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. 

Main Mingora Road, Odigram, Tel: 1946-883946-47 Swat, Khyber Pakhtunkhwa Email: 
info@inuswat.edu.pk  
 
3. Study Design 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).  
4. Participants Inclusion: Age 45–78; ischemic/hemorrhagic stroke ≥6 months prior;  
Functional Ambulation Category (FAC) ≥3; BMI ≥25 kg/m²; systolic BP ≥130 mmHg  
(stable antihypertensives allowed); able to provide informed consent. Exclusion: Unstable  
cardiovascular conditions; severe cognitive impairment (MMSE <20); other neurological  
disorders affecting gait; musculoskeletal issues limiting training; recent intensive exercise  
programs; life expectancy <12 months. Recruitment: Outpatient clinics, stroke registries,  
referrals, community outreach. Target sample: 144 (48 per group) Sample size  
justification: Detect 3 kg weight change (SD 4 kg) and 10 mmHg systolic BP change (SD  
12 mmHg), 80% power, α=0.05, 15% attrition, accounting for multicenter clustering  (ICC 
0.01).  
5. Randomization & Blinding Sequence: Computer-generated permuted blocks (sizes  
3,6,9), stratified by FAC (3 vs. ≥4) and BMI (25–29.9 vs. ≥30 kg/m²) Concealment:  
Secure web-based central system (backup: sequentially numbered, opaque envelopes)  
Implementation: Site coordinators enroll; independent platform assigns Blinding:  
Assessors and statisticians blinded; participants/therapists unblinded (intervention  
nature); groups coded in database.  
6. Interventions All groups: 30 sessions over 12 weeks (3–5/week, 45–60 min), heart rate  
monitored (60–80% reserve). No additional exercise or diet interventions.  
Group A (Hybrid: EAGT → CGT): 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): Full 12 weeks EAGT, progressing parameters for intensity. 
Group C (CGT-only): Full 12 weeks CGT, progressing complexity and demands.  
7. Outcome Measures Primary: Change in body weight; systolic/diastolic BP. Secondary:  
10-Meter Walk Test (speed); 6-Minute Walk Test (endurance); Berg Balance Scale;  
Barthel Index. Timepoints: Baseline, 6 weeks, 12 weeks, 3-month follow-up.  
8. Data Collection & Management Standardized forms; secure, anonymized electronic  

storage; adherence logs (attendance, steps, heart rate, adverse events).  
9. Statistical Analysis Intention-to-treat; linear mixed-effects models (SPSS v28/R  v4.3.2); 
fixed effects: group, time, interaction; random effects: participant/center;  
Main Mingora Road, Odigram, Tel: 1946-883946-47 Swat, Khyber Pakhtunkhwa Email: 
info@inuswat.edu.pk  
 
multiple imputation for missing data; subgroup analyses (BMI, post-stroke duration);  
Bonferroni adjustments; effect sizes (η²p, Cohen's d).  
10. Ethical Considerations Written informed consent; data confidentiality; minimized risks  
(fatigue monitoring); independent data monitoring committee for safety; adherence to  
Helsinki Declaration and GCP.  
11. Timeline Recruitment: January 2022 – June 2024,Follow-up: Until June 
2025  
12. Protocol Deviations Any deviations will be reported and documented.  
Sincerely,  
Assistant Registrar  
 

Main Mingora Road, Odigram, Tel: 1946-883946-47 Swat, Khyber Pakhtunkhwa Email: 
info@inuswat.edu.pk