Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:51 AM
Study NCT ID:
NCT07420595
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Training for Concurrent Optimization of Weight Mgt,bp Regulation and Functional Mobility
Sponsor:
Iqra National University
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: