Al Hayah University in Cairo
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: Supervised 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.
Distal Radius Fractures
Supervised Therapy for DRF Rehabilitation
Home-Based Rehabilitation Program for DRF
Minimal Educational Intervention for DRF
NA
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. After cast removal (typically 4-6 weeks), eligible participants will be randomized into one of three groups: Supervised 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). Home-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. No Therapy Group (NTG): Participants receive minimal instructions and an educational brochure (e.g., "move your wrist as tolerated") without formal exercise supervision. Intervention components follow the TIDieR (Template for Intervention Description and Replication) guidelines: Materials: STG: Standard therapy equipment (theraband, therapy putty). HBG: Written and online exercise manual; exercise logs for self-report. NTG: General educational brochure. Procedures: STG: 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. Who Provides: STG: Licensed physical therapists. HBG: Research assistants provide check-ins. NTG: No active provider contact. Where: STG: Outpatient clinic visits. HBG: Participant's home with telephone support. NTG: No additional intervention setting. When and How Much: Duration: 6 weeks of intervention post-cast removal; full study follow-up over 6 months. Frequency: 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. Modifications: Adjust therapy intensity for pain or reported complications; referral back to the treating surgeon if necessary. Adherence: STG attendance is tracked; HBG requires exercise logs; NTG has no structured adherence measures. Planned Assessments: Baseline (at cast removal), 6 weeks, 3 months, and 6 months follow-up.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 96 participants |
| Masking : | SINGLE |
| Primary Purpose : | TREATMENT |
| Official Title : | 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 |
| Actual Study Start Date : | 2025-04-21 |
| Estimated Primary Completion Date : | 2026-04-21 |
| Estimated Study Completion Date : | 2026-04-21 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311