NCT06913894

Supervised vs. Home-Based vs. No Therapy for Uncomplicated Distal Radius Fracture in Younger Adults

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Al Hayah University In Cairo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Distal Radius Fractures

Interventions

Type	Name	Description
BEHAVIORAL	Supervised Therapy for DRF Rehabilitation	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.
BEHAVIORAL	Home-Based Rehabilitation Program for DRF	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.
BEHAVIORAL	Minimal Educational Intervention for DRF	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.

Timeline

• Start date: 2025-04-21
• Primary completion: 2026-04-21
• Completion: 2026-04-21
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: Egypt