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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-25', 'size': 172628, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-11T09:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, assessor-blinded, three-arm parallel-group RCT Allocation:\n\n1:1:1 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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': '10 meter walk test to measure functional mobility'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome', 'timeFrame': '3-month follow-up', 'description': 'Barthel Index to assess functional independence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'stroke sequelae'], 'conditions': ['Cardiovascular Diseases', 'Stroke Sequelae']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://osf.io/bf3jd/overview', 'label': 'data set'}]}, 'descriptionModule': {'briefSummary': '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.\n\nElectromechanically assisted gait training (EAGT) provides high-intensity, repetitive practice, while conventional gait training (CGT) enhances real-world functional transfer.\n\nEvidence 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic/hemorrhagic stroke ≥6 months prior\n* Functional Ambulation Category (FAC) ≥3; BMI ≥25 kg/m²; systolic BP ≥130 mmHg.\n* able to provide informed consent\n\nExclusion Criteria:\n\n* Unstable cardiovascular conditions\n* Severe cognitive impairment (MMSE \\<20)\n* Other neurological disorders affecting gait\n* Musculoskeletal issues limiting training'}, 'identificationModule': {'nctId': 'NCT07420595', 'briefTitle': 'Gait Training for Concurrent Optimization of Weight Mgt,bp Regulation and Functional Mobility', 'organization': {'class': 'OTHER', 'fullName': 'Iqra National University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'INU/REHAB/XC121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Hybrid: EAGT → CGT)', 'description': '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).', 'interventionNames': ['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.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (EAGT-only):', 'description': 'Full 12 weeks EAGT, progressing parameters for intensity.', 'interventionNames': ['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.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C (CGT-only)', 'description': 'Full 12 weeks CGT, progressing complexity and demands.', 'interventionNames': ['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': [{'name': '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).', 'type': 'OTHER', 'otherNames': ['Full 12 weeks EAGT, progressing parameters for intensity.'], 'description': 'already mentioned', 'armGroupLabels': ['Group A (Hybrid: EAGT → CGT)', 'Group B (EAGT-only):', 'Group C (CGT-only)']}, {'name': 'Full 12 weeks CGT, progressing complexity and demands.', 'type': 'OTHER', 'description': 'Group C (CGT-only)', 'armGroupLabels': ['Group A (Hybrid: EAGT → CGT)', 'Group B (EAGT-only):', 'Group C (CGT-only)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Swat', 'state': 'Peshawar', 'country': 'Pakistan', 'facility': 'IQRA National University', 'geoPoint': {'lat': 35.37925, 'lon': 72.17562}}], 'overallOfficials': [{'name': 'Ayman Abdullah Alhammad', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taibah University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'due to ethical considerations as per ethical approval document'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iqra National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Muslim khan', 'investigatorAffiliation': 'Iqra National University'}}}}