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

NCT06913894 | Recruiting

• 1 other identifier: DRFRecov2025-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• Patient-Rated Wrist Evaluation (PRWE) Total Score

  The PRWE is a validated instrument assessing wrist pain and disability on a 0-100 scale (lower scores indicate better outcomes).

  Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.

Secondary Outcomes (3)

• Wrist/Forearm Range of Motion (ROM)

  Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.

• Upper Limb Disability (QuickDASH)

  Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.

• Return-to-Activity Timeline

  Recorded at 3 and 6 months post-intervention.

Study Arms (3)

Supervised Therapy Group (STG)

EXPERIMENTAL

Participants will attend once-weekly supervised outpatient sessions (30-45 min) with a physical therapist for 6 weeks, in addition to a daily home exercise program (10-15 min).

Behavioral: Supervised Therapy for DRF Rehabilitation

Home-Based Program Group (HBG)

EXPERIMENTAL

Participants perform a standardized home exercise program daily with weekly telephone or video follow-up (10 min sessions) over 6 weeks.

Behavioral: Home-Based Rehabilitation Program for DRF

No Therapy Group (NTG)

ACTIVE COMPARATOR

Participants receive minimal instruction via a general educational brochure (e.g., "move your wrist as tolerated") without formal exercise supervision.

Behavioral: Minimal Educational Intervention for DRF

Interventions

Supervised Therapy for DRF Rehabilitation BEHAVIORAL

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.

Supervised Therapy Group (STG)

Home-Based Rehabilitation Program for DRF BEHAVIORAL

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.

Home-Based Program Group (HBG)

Minimal Educational Intervention for DRF BEHAVIORAL

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.

No Therapy Group (NTG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Ibrahim Zoheiry, Ph.D

CONTACT

01277774949; ibrahim.alzoheiry@hotmail.com

Mohamed ElMeligie, Ph.D

CONTACT

mohamed.elmeligie@ahuc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 21, 2025
• Primary Completion: April 21, 2026
• Study Completion: April 21, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)