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

NCT07420595 | Completed

• 1 other identifier: INU/REHAB/XC121
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Stroke Sequelae

Keywords

stroke; stroke sequelae

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  10 meter walk test to measure functional mobility

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (1)

• Secondary outcome

  3-month follow-up

Study Arms (3)

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).

Other: 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: Full 12 weeks CGT, progressing complexity and demands.

Group B (EAGT-only):

ACTIVE COMPARATOR

Full 12 weeks EAGT, progressing parameters for intensity.

Other: 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: Full 12 weeks CGT, progressing complexity and demands.

Group C (CGT-only)

ACTIVE COMPARATOR

Full 12 weeks CGT, progressing complexity and demands.

Other: 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: Full 12 weeks CGT, progressing complexity and demands.

Interventions

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

Also known as: Full 12 weeks EAGT, progressing parameters for intensity.

Group A (Hybrid: EAGT → CGT); Group B (EAGT-only):; Group C (CGT-only)

Full 12 weeks CGT, progressing complexity and demands. OTHER

Group C (CGT-only)

Group A (Hybrid: EAGT → CGT); Group B (EAGT-only):; Group C (CGT-only)

Eligibility Criteria

• Age: 45 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic/hemorrhagic stroke ≥6 months prior
• Functional Ambulation Category (FAC) ≥3; BMI ≥25 kg/m²; systolic BP ≥130 mmHg.
• able to provide informed consent

You may not qualify if:

• Unstable cardiovascular conditions
• Severe cognitive impairment (MMSE \<20)
• Other neurological disorders affecting gait
• Musculoskeletal issues limiting training

Sponsors & Collaborators

• Iqra National University: lead

Study Sites (1)

IQRA National University

Swat, Peshawar, Pakistan

Location

Related Links

• data set

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Ayman Abdullah Alhammad

  Taibah University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: January 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)