Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06913894
Brief 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.
Study:
NCT06913894
Study Brief:
Protocol Section:
NCT06913894