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:
Al Hayah University In Cairo
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: