Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 8:19 PM
Study NCT ID:
NCT05834192
Status:
UNKNOWN
Last Update Posted:
2023-04-28
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Extremity Functional Scale (LEFS)', 'timeFrame': '8 weeks', 'description': "It consists of 20 questions designed to assess a person's ability to perform everyday tasks, such as getting into or out of the bath, walking between rooms, squatting, and sitting for 1 hour. Performance is rated on a 5-point scale with maximum score of 80. Lower score shows greater disability"}, {'measure': 'Tinetti Performance Oriented Mobility Assessment (POMA)', 'timeFrame': '8 weeks', 'description': 'it comprises 16 items (9 balance-related and 7 gait-related items). The highest achievable score being 28 points (16 for balance and 12 for gait). A higher score indicates better balance. A cutoff score greater than 17 points has been associated with fall risk in the older adult population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is one of the high rated neurological disorders, induced by disruption of brain\'s blood flow. Stroke can alter the level of consciousness, motor and cognitive skills, sensory perception and language; it all depends on the extent of injury and the region of brain that is affected. Even though all the rehabilitation given to the "stroke" patients, but still 25-30% of the survivors still have gait and balance problem and they require complete physical support before their discharge from the hospital. Backward treadmill walking has reported numerous benefits in improving balance, motor function and gait. Cross training is a technique which is applied to healthy limb of the individual to increase muscle strength and muscle activity.so the aim of this study is to find the effects of backward treadmill walking and lower extremity cross training on gross motor function and balance among stroke patients.\n\nThe study will be randomized clinical trials, Participants will be randomly allocated into two groups each group will have 13. This study will be conducted in Safi teaching Hospital Faisalabad. Group A will be treated with backward treadmill walking and group B will be treated with lower extremity cross training. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. Outcome will be measured before and after giving treatment by using Tinetti performance oriented mobility assessment and lower extremity functional scale. The results will be calculated by using SPSS version 25. Frequencies and mean standard deviation will be measured, parametric and non-parametric tests will be applied'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiplegic stroke patient diagnosed within last 6 months to 1 year\n* Age 55 to 75 years\n* Cognition score on Mini-mental state examination \\> 24\n* Able to independently walk 10 m without walking aids\n* Able to understand instructions\n\nExclusion Criteria:\n\n* Who will have visual or vestibular injury\n* Patients having history of orthopedic surgery or having an orthopedic condition\n* Who will have \\>grade 2 on modified Ashworth Scale (MAS)'}, 'identificationModule': {'nctId': 'NCT05834192', 'briefTitle': 'Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training Among Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparative Effects of Backward Treadmill Walking and Lower Extremity Cross Training on Gross Motor Function and Balance Among Stroke Patients', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Backward treadmill walking group', 'interventionNames': ['Other: Backward treadmill walking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lower extremity cross training', 'interventionNames': ['Other: Lower extremity cross training']}], 'interventions': [{'name': 'Backward treadmill walking', 'type': 'OTHER', 'description': 'Backward Treadmill walking will be given to this group. Speed settings of treadmill will be established based on the previous motor function of participants. All participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down.', 'armGroupLabels': ['Backward treadmill walking group']}, {'name': 'Lower extremity cross training', 'type': 'OTHER', 'description': 'For cross-training, a strong resistance will be applied by the therapist until a response will be achieved on the contralateral lower extremity at the end range of motion. Resistance will be consistently applied for 10 seconds once a response will be achieved.\n\nAll participants will receive conventional physical exercises which includes general mobility and functional activities. In this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down.', 'armGroupLabels': ['Lower extremity cross training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalābad', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Shahid Shafique, DPT', 'role': 'CONTACT', 'email': 'shahidshafiq777@gmail.com', 'phone': '03326649539'}, {'name': 'Touseeq Ahmad, Masters', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Safi teaching hospital Faisalabad'}], 'centralContacts': [{'name': 'Hira Jabeen, Masters', 'role': 'CONTACT', 'email': 'hira.jabeen@riphah.edu.pk', 'phone': '+923234116506'}, {'name': 'Touseeq Ahmad, MS-PT (NMPT)', 'role': 'CONTACT', 'email': 'Tousiq875@gmail.com', 'phone': '+923018199862'}], 'overallOfficials': [{'name': 'Hira Jabeen, Masters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}