Cardiovascular DiseasesNCT07420595
Gait Training for Concurrent Optimization of Weight Mgt,bp Regulation and Functional Mobility
A study testing 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). and Full 12 weeks CGT, progressing complexity and demands. in people with Cardiovascular Diseases and Stroke Sequelae, run by Iqra National University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 78 years
- Conditions the study is for
- Cardiovascular Diseases, Stroke Sequelae
- What is being tested?
- 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). and Full 12 weeks CGT, progressing complexity and demands.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic/hemorrhagic stroke ≥6 months prior
- Functional Ambulation Category (FAC) ≥3; BMI ≥25 kg/m²; systolic BP ≥130 mmHg.
- able to provide informed consent
Who cannot join
- Unstable cardiovascular conditions
- Severe cognitive impairment (MMSE <20)
- Other neurological disorders affecting gait
- Musculoskeletal issues limiting training
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Cardiovascular Diseases, Stroke Sequelae
- Being tested
- 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)., Full 12 weeks CGT, progressing complexity and demands.
- Keywords
- stroke, stroke sequelae
- Medical subject headings
- Cardiovascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Full 12 weeks EAGT, progressing parameters for intensity.
already mentioned
Full 12 weeks CGT, progressing complexity and demands.Other
Group C (CGT-only)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
10 meter walk test to measure functional mobility
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (1)
Secondary outcome
Barthel Index to assess functional independence.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iqra National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muslim khan, Iqra National University
- Investigators
- Ayman Abdullah Alhammad, Study director, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420595
- Sponsor's protocol ID
- INU/REHAB/XC121
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical considerations as per ethical approval document
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07420595
- Acronym / sponsor ID
- INU/REHAB/XC121
- Conditions
- Cardiovascular Diseases, Stroke Sequelae
- Keywords
- stroke, stroke sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Iqra National UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group A (Hybrid: EAGT → CGT) | Active comparator | 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.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): | Active comparator | 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.Full 12 weeks EAGT, progressing parameters for intensity. |
| Group C (CGT-only) | Active comparator | 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.Full 12 weeks CGT, progressing complexity and demands. |
Who may qualify
- Ages
- 45 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic/hemorrhagic stroke ≥6 months prior
- Functional Ambulation Category (FAC) ≥3; BMI ≥25 kg/m²; systolic BP ≥130 mmHg.
- able to provide informed consent
Key exclusion criteria (4 listed)
- Unstable cardiovascular conditions
- Severe cognitive impairment (MMSE <20)
- Other neurological disorders affecting gait
- Musculoskeletal issues limiting training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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).Also: Full 12 weeks EAGT, progressing parameters for intensity.already mentioned | Other | Group A (Hybrid: EAGT → CGT), Group B (EAGT-only):, Group C (CGT-only) |
| Full 12 weeks CGT, progressing complexity and demands.Group C (CGT-only) | Other | Group A (Hybrid: EAGT → CGT), Group B (EAGT-only):, Group C (CGT-only) |
Primary outcome
Primary outcome
Time frame: Baseline, 6 weeks, 12 weeks
10 meter walk test to measure functional mobility
1 secondary outcome
Secondary outcome
Time frame: 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- data setLink provided by the sponsor.
- Individual participant dataSharing planned: No. due to ethical considerations as per ethical approval document
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Abdullah Alhammad study director
Taibah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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). and Full 12 weeks CGT, progressing complexity and demands. in people with Cardiovascular Diseases and Stroke Sequelae, run by Iqra National University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.