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Gait Training for Concurrent Optimization of Weight Mgt,bp Regulation and Functional Mobility

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07420595
Enrollment
140
Registered
2026-02-19
Start date
2022-01-01
Completion date
2025-12-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Stroke Sequelae

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

OTHERWeeks 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).

already mentioned

OTHERFull 12 weeks CGT, progressing complexity and demands.

Group C (CGT-only)

Sponsors

Iqra National University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
45 Years to 78 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Primary outcomeBaseline, 6 weeks, 12 weeks10 meter walk test to measure functional mobility

Secondary

MeasureTime frameDescription
Secondary outcome3-month follow-upBarthel Index to assess functional independence.

Countries

Pakistan

Contacts

STUDY_DIRECTORAyman Abdullah Alhammad

Taibah University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026