Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-13 @ 6:13 PM
Study NCT ID:
NCT07125157
Status:
WITHDRAWN
Last Update Posted:
2025-09-03
First Post:
2025-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Task-Specific Training With And Without Biofeedback On Balance And Risk Of Falls In Chronic Ischemic Stroke Patients Of Central Lahore, Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will be blinded to group allocation. Due to the nature of the intervention, therapists and participants cannot be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of two groups: one receiving task-specific training with biofeedback and the other receiving task-specific training without biofeedback.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Record submitted under wrong account; no participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance performance as measured by Berg Balance Scale (BBS)', 'timeFrame': 'Baseline (T0), Post-intervention (12 weeks, T2), and Follow-up (3 months post-intervention, TX)', 'description': 'The BBS will assess balance performance across 14 items related to functional tasks such as sitting, standing, reaching, and turning. It is a widely validated tool in stroke rehabilitation.'}], 'secondaryOutcomes': [{'measure': 'Risk of falls as measured by the Timed Up and Go (TUG) test', 'timeFrame': 'Baseline, Post-intervention (12 weeks), and Follow-up (3 months)', 'description': 'The TUG test measures functional mobility and fall risk. The time (in seconds) to rise from a chair, walk 3 meters, turn, return, and sit is recorded. Lower times indicate better mobility and lower fall risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke rehabilitation', 'biofeedback', 'task specific training', 'balance training', 'fall prevention', 'berg balance scale', 'time up and go'], 'conditions': ['Chronic Ischemic Stroke', 'Balance Impairment', 'Risk of Fall']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effects of task-specific training with and without biofeedback compared to conventional physical therapy on balance and fall risk in chronic ischemic stroke patients in Lahore, Pakistan. Sixty-six participants will be randomly allocated into three groups: Group 1 (task-specific training with biofeedback), Group 2 (task-specific training without biofeedback), and Group 3 (conventional physical therapy). The intervention will span 12 weeks, consisting of 36 sessions. Key outcome measures include the Berg Balance Scale, Timed Up and Go Test, and the Barthel Index. Assessments will be conducted at baseline, post-intervention, and three-month follow-up. The study hypothesizes that the use of biofeedback in task-specific training will produce significantly greater improvements in balance and reduced fall risk compared to conventional rehabilitation strategies. The study is being conducted at Shadman Medical Center in Lahore and is part of a PhD project from Lincoln University College.', 'detailedDescription': "This randomized controlled trial investigates the comparative effectiveness of task-specific training with biofeedback, without biofeedback, and conventional physical therapy in improving balance and reducing fall risk among chronic ischemic stroke patients. The study consists of 66 participants, randomly assigned to three groups. Group 1 receives task-specific training using the Motor Relearning Program (MRP) principles, augmented with virtual reality-based biofeedback. Group 2 follows the same task-specific training without biofeedback. Group 3 receives conventional physical therapy following standard post-stroke rehabilitation protocols.\n\nParticipants will undergo 36 treatment sessions over a 12-week period, with three one-hour sessions per week. All interventions are delivered by qualified physiotherapists at the Department of Neurological and Functional Rehabilitation, Shadman Medical Center, Lahore.\n\nOutcomes will be assessed using the Berg Balance Scale (BBS), Timed Up and Go (TUG) test, and the Barthel Index (BI) at baseline, post-intervention, and a 3-month follow-up. Randomization will be computer-generated, with blinding applied to assessors and data analysts.\n\nThe primary objective is to examine whether task-specific training with biofeedback significantly improves dynamic and static balance and reduces fall risk more effectively than the other two methods. Data will be analyzed using SPSS v21.0, applying repeated measures ANOVA and Cohen's d for effect size. A p-value ≤ 0.05 will be considered statistically significant.\n\nThe study has received ethical approval from Lincoln University College and is conducted under informed consent. Results will contribute to doctoral research and be submitted for peer-reviewed publication and presentation at scientific forums."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChronic ischemic stroke patients (more than 3 months after stroke) (Batcho et al., 2013) Both Male and Female Patients (Gibson and Attwood, 2016) Patients of 40 or above years of age (Yi et al., 2020) Patients with Burnstorm stage 3 or above.(Stefancic et al., 2016) Patients with good cognitive function (score of 20 or more on MMSE) (Mitchell, 2013) Patients who can ambulate 10 m (with or without the assistive device) (Hatem et al., 2016)\n\nExclusion Criteria:\n\nPatients undergoing concurrent therapy or treatment that could influence the effectiveness of this study will be excluded from participation (Gadidi et al., 2011) Patients presenting with contraindications to rehabilitation, such as severe uncontrolled hypertension, uncontrolled diabetes, or unstable angina, will be excluded from the study.(Billinger et al., 2014) Individuals with prior neurological impairments apart from stroke.'}, 'identificationModule': {'nctId': 'NCT07125157', 'acronym': 'TST-BIO-STROKE', 'briefTitle': 'Effect Of Task-Specific Training With And Without Biofeedback On Balance And Risk Of Falls In Chronic Ischemic Stroke Patients Of Central Lahore, Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Lincoln University College'}, 'officialTitle': 'Effect Of Task-Specific Training With And Without Biofeedback On Balance And Risk Of Falls In Chronic Ischemic Stroke Patients Of Central Lahore, Pakistan, A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LUC/Ethc/Admin/SP/004/726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Task-Specific Training with Biofeedback', 'description': 'Participants in this group will receive task-specific training combined with biofeedback. The intervention will focus on functional activities that challenge balance and mobility, while real-time feedback will be provided to improve motor control and postural stability. Training will be conducted under supervision for a set duration and frequency over the intervention period.', 'interventionNames': ['Behavioral: Task-Specific Training with Biofeedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Task-Specific Training without Biofeedback', 'description': 'Participants in this group will receive the same task-specific training protocol without biofeedback. Functional tasks will be practiced to enhance balance and reduce fall risk. Training will be identical in duration and intensity to the experimental group but will not include feedback mechanisms.', 'interventionNames': ['Behavioral: Task-Specific Training without Biofeedback']}], 'interventions': [{'name': 'Task-Specific Training with Biofeedback', 'type': 'BEHAVIORAL', 'otherNames': ['Biofeedback-assisted task training'], 'description': 'Participants in this group will undergo task-specific training focused on improving balance and reducing fall risk. Real-time biofeedback (e.g., visual or auditory cues) will be integrated into the training to enhance motor learning and postural adjustments. Sessions will be supervised and conducted multiple times per week over the intervention period.', 'armGroupLabels': ['Task-Specific Training with Biofeedback']}, {'name': 'Task-Specific Training without Biofeedback', 'type': 'BEHAVIORAL', 'otherNames': ['Conventional task training'], 'description': 'Participants will receive task-specific training aimed at improving balance and fall prevention without any biofeedback assistance. The same set of functional exercises and session frequency will be followed as in the experimental group, ensuring the only difference is the absence of feedback stimuli.', 'armGroupLabels': ['Task-Specific Training without Biofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shadman Medical Center', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Syed Ali Behram Subazwari, Phd physiotherapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lincoln University College Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syed Ali Behram Subazwari', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lincoln University College Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Subazwari Syed Ali Behram', 'investigatorFullName': 'Syed Ali Behram Subazwari', 'investigatorAffiliation': 'Lincoln University College'}}}}