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Completed

NCT Number: NCT07420595

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

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.

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Key information

Conditions

Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Stroke Sequelae Vascular Diseases

Age range

45 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IQRA National University

Swat, Peshawar, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Full 12 weeks EAGT, progressing parameters for intensity.

Full 12 weeks CGT, progressing complexity and demands.

Other

Group C (CGT-only)

Primary outcomes

  1. Primary outcome

    Time frame: Baseline, 6 weeks, 12 weeks

    10 meter walk test to measure functional mobility

Secondary outcomes

  1. Secondary outcome

    Time frame: 3-month follow-up

    Barthel Index to assess functional independence.

Sponsors and collaborators

Lead sponsor

Iqra National University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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