Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT06913894
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supervised vs. Home-Based vs. No Therapy for Uncomplicated Distal Radius Fracture in Younger Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible adults will be randomly assigned to one of three groups: Supervised Therapy, Home-Based Program, or No Therapy. The groups differ only in the rehabilitation method post-cast removal, with all participants followed for 6 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Rated Wrist Evaluation (PRWE) Total Score', 'timeFrame': 'Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.', 'description': 'The PRWE is a validated instrument assessing wrist pain and disability on a 0-100 scale (lower scores indicate better outcomes).'}], 'secondaryOutcomes': [{'measure': 'Wrist/Forearm Range of Motion (ROM)', 'timeFrame': 'Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.', 'description': 'ROM will be measured using a standard goniometer.'}, {'measure': 'Upper Limb Disability (QuickDASH)', 'timeFrame': 'Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.', 'description': 'The QuickDASH is an 11-item questionnaire evaluating upper limb function; lower scores indicate less disability.'}, {'measure': 'Return-to-Activity Timeline', 'timeFrame': 'Recorded at 3 and 6 months post-intervention.', 'description': 'The number of days required to resume work and/or sports will be documented.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fractures']}, 'descriptionModule': {'briefSummary': 'This three-arm, parallel-group RCT will compare the effectiveness of three rehabilitation strategies following conservative treatment of an uncomplicated distal radius fracture in adults under 50 years old. The study will compare:\n\nSupervised Therapy: Outpatient physical therapy sessions plus a daily home exercise program Home-Based Program: A structured, detailed home exercise program with weekly telephone follow-up No Therapy (minimal intervention): Standard minimal instruction via an educational brochure The primary outcome is the Patient-Rated Wrist Evaluation (PRWE) measured at 6 weeks and 6 months.', 'detailedDescription': 'Uncomplicated, nonoperatively treated distal radius fractures in younger adults (18-50 years) are common, yet current guidelines offer a "D" rating regarding optimal rehabilitation-specifically, whether structured, supervised therapy, a detailed home-based program, or no formal therapy is best. A lack of consensus may delay optimal recovery and unnecessarily increase healthcare usage.\n\nAfter cast removal (typically 4-6 weeks), eligible participants will be randomized into one of three groups:\n\nSupervised Therapy Group (STG): Participants attend once-weekly, 30- to 45-minute outpatient sessions with a licensed physical therapist for 6 weeks, focusing on progressive range of motion, light strengthening, proprioception, and functional tasks. They also perform a short daily home exercise program (10-15 minutes).\n\nHome-Based Program Group (HBG): Participants perform a standardized, detailed exercise program at home, self-administered daily. They receive weekly phone or video follow-up (approximately 10 minutes) from research assistants.\n\nNo Therapy Group (NTG): Participants receive minimal instructions and an educational brochure (e.g., "move your wrist as tolerated") without formal exercise supervision.\n\nIntervention components follow the TIDieR (Template for Intervention Description and Replication) guidelines:\n\nMaterials:\n\nSTG: Standard therapy equipment (theraband, therapy putty). HBG: Written and online exercise manual; exercise logs for self-report. NTG: General educational brochure.\n\nProcedures:\n\nSTG: In-person 30-45-minute sessions weekly, plus daily home exercises. HBG: Self-directed exercise program with weekly telephonic check-ins. NTG: Minimal instruction only.\n\nWho Provides:\n\nSTG: Licensed physical therapists. HBG: Research assistants provide check-ins. NTG: No active provider contact.\n\nWhere:\n\nSTG: Outpatient clinic visits. HBG: Participant\'s home with telephone support. NTG: No additional intervention setting.\n\nWhen and How Much:\n\nDuration: 6 weeks of intervention post-cast removal; full study follow-up over 6 months.\n\nFrequency: STG = 1 clinical session per week + daily (\\~10-15 minute) home exercises; HBG = daily home routine with 1 weekly call; NTG = educational brochure at baseline.\n\nModifications:\n\nAdjust therapy intensity for pain or reported complications; referral back to the treating surgeon if necessary.\n\nAdherence:\n\nSTG attendance is tracked; HBG requires exercise logs; NTG has no structured adherence measures.\n\nPlanned Assessments:\n\nBaseline (at cast removal), 6 weeks, 3 months, and 6 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18-50 years. Diagnosed with an extra-articular, stable distal radius fracture treated nonoperatively with a short-arm cast for approximately 4-6 weeks.\n\nThe fracture is uncomplicated (no significant soft-tissue injury, no evidence of CRPS, and no other major complications).\n\nWilling to provide written informed consent and comply with follow-up assessments.\n\nExclusion Criteria:\n\nIntra-articular or unstable fracture patterns. Surgical intervention planned or performed for the distal radius fracture. Presence of significant comorbidities (e.g., chronic inflammatory arthritis or severe neurological impairment affecting the injured limb).\n\nFracture complications such as CRPS or major soft-tissue injury. Inability to comply with study procedures or follow-up assessments. Pregnant or breastfeeding individuals.'}, 'identificationModule': {'nctId': 'NCT06913894', 'briefTitle': 'Supervised vs. Home-Based vs. No Therapy for Uncomplicated Distal Radius Fracture in Younger Adults', 'organization': {'class': 'OTHER', 'fullName': 'Al Hayah University In Cairo'}, 'officialTitle': 'Supervised Therapy Versus a Standardized Home-Based Program Versus No Formal Therapy for Uncomplicated, Nonoperatively Treated Distal Radius Fracture in Adults Under 50: A Three-Arm, Parallel-Group Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DRFRecov2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised Therapy Group (STG)', 'description': 'Participants will attend once-weekly supervised outpatient sessions (30-45 min) with a physical therapist for 6 weeks, in addition to a daily home exercise program (10-15 min).', 'interventionNames': ['Behavioral: Supervised Therapy for DRF Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Home-Based Program Group (HBG)', 'description': 'Participants perform a standardized home exercise program daily with weekly telephone or video follow-up (10 min sessions) over 6 weeks.', 'interventionNames': ['Behavioral: Home-Based Rehabilitation Program for DRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Therapy Group (NTG)', 'description': 'Participants receive minimal instruction via a general educational brochure (e.g., "move your wrist as tolerated") without formal exercise supervision.', 'interventionNames': ['Behavioral: Minimal Educational Intervention for DRF']}], 'interventions': [{'name': 'Supervised Therapy for DRF Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the Supervised Therapy Group (STG) will receive in-person, supervised rehabilitation sessions in an outpatient clinic. Each session lasts 30-45 minutes and is conducted by a licensed physical therapist. The therapy focuses on progressive range of motion exercises, light strengthening, proprioception training, and functional task practice. In addition, participants are prescribed a daily home exercise program (lasting 10-15 minutes) to reinforce gains made during the clinic sessions. The intervention is provided over a 6-week period following cast removal, with adherence monitored via attendance records and home exercise logs.', 'armGroupLabels': ['Supervised Therapy Group (STG)']}, {'name': 'Home-Based Rehabilitation Program for DRF', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the Home-Based Program Group (HBG) will follow a standardized, detailed home exercise program specifically designed for distal radius fracture rehabilitation. The program includes instructions for range of motion, strengthening, and functional tasks similar to the supervised protocol. Participants receive a comprehensive written and online exercise manual, and they are instructed to perform the exercises daily. In addition, they will have weekly telephone or video check-ins (approximately 10 minutes per call) with a research assistant to review progress, address questions, and ensure proper exercise technique. The home program is implemented over a 6-week period following cast removal, with adherence documented via exercise logs submitted by participants.', 'armGroupLabels': ['Home-Based Program Group (HBG)']}, {'name': 'Minimal Educational Intervention for DRF', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the No Therapy Group (NTG) will receive a minimal intervention consisting solely of general educational material. At the time of cast removal, they will be provided with a simple, standardized educational brochure that contains basic instructions for wrist and hand movement (e.g., "move your wrist as tolerated"). No additional therapy sessions, home exercise logs, or follow-up telephone calls will be provided beyond routine care. This intervention is intended to reflect the absence of a formal rehabilitation program and serves as the control for evaluating the added benefit of supervised and home-based therapy.', 'armGroupLabels': ['No Therapy Group (NTG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed ElMeligie, Ph.D', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@ahuc.edu.eg', 'phone': '01159880001', 'phoneExt': '+20'}], 'facility': 'Faculty of Physical Therapy, Al Hayah University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ibrahim Zoheiry, Ph.D', 'role': 'CONTACT', 'email': 'ibrahim.alzoheiry@hotmail.com', 'phone': '01277774949', 'phoneExt': '+20'}, {'name': 'Mohamed ElMeligie, Ph.D', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@ahuc.edu.eg', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Hayah University In Cairo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}