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

March 31, 2025 updated by: Al Hayah University In Cairo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 12311
        • Recruiting
        • Faculty of Physical Therapy, Al Hayah University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Therapy Group (STG)
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
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.
Experimental: Home-Based Program Group (HBG)
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
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.
Active Comparator: No Therapy Group (NTG)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Rated Wrist Evaluation (PRWE) Total Score
Time Frame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrist/Forearm Range of Motion (ROM)
Time Frame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
ROM will be measured using a standard goniometer.
Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
Upper Limb Disability (QuickDASH)
Time Frame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
The QuickDASH is an 11-item questionnaire evaluating upper limb function; lower scores indicate less disability.
Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
Return-to-Activity Timeline
Time Frame: Recorded at 3 and 6 months post-intervention.
The number of days required to resume work and/or sports will be documented.
Recorded at 3 and 6 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Hayah University In Cairo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 21, 2025

Primary Completion (Estimated)

April 21, 2026

Study Completion (Estimated)

April 21, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRFRecov2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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