Clinical trial NCT06913894: Supervised vs. Home-Based vs. No Therapy for Uncomplicated Distal Radius Fracture in Younger Adults
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Adults 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.

The fracture is uncomplicated (no significant soft-tissue injury, no evidence of CRPS, and no other major complications).

Willing to provide written informed consent and comply with follow-up assessments.

Exclusion Criteria:

Intra-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).

Fracture complications such as CRPS or major soft-tissue injury. Inability to comply with study procedures or follow-up assessments. Pregnant or breastfeeding individuals.

Primary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE) Total Score
timeFrame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
Secondary outcomes:
measure: Wrist/Forearm Range of Motion (ROM)
timeFrame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
measure: Upper Limb Disability (QuickDASH)
timeFrame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
measure: Return-to-Activity Timeline
timeFrame: Recorded at 3 and 6 months post-intervention.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: