Distal Radius FracturesNCT06913894
Supervised vs. Home-Based vs. No Therapy for Uncomplicated Distal Radius Fracture in Younger Adults
A study testing Supervised Therapy for DRF Rehabilitation, Home-Based Rehabilitation Program for DRF and Minimal Educational Intervention for DRF in people with Distal Radius Fractures, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Supervised Therapy for DRF Rehabilitation, Home-Based Rehabilitation Program for DRF and Minimal Educational Intervention for DRF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2025to 21 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed ElMeligie, Ph.D contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
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
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.
Read the 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.
- Conditions
- Distal Radius Fractures
- Being tested
- Supervised Therapy for DRF Rehabilitation, Home-Based Rehabilitation Program for DRF, Minimal Educational Intervention for DRF
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Therapy for DRF RehabilitationBehavioural
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.
Home-Based Rehabilitation Program for DRFBehavioural
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.
Minimal Educational Intervention for DRFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Behavioral: Minimal Educational Intervention for DRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
Secondary outcomes (3)
Wrist/Forearm Range of Motion (ROM)
ROM will be measured using a standard goniometer.
Measured: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
Upper Limb Disability (QuickDASH)
The QuickDASH is an 11-item questionnaire evaluating upper limb function; lower scores indicate less disability.
Measured: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.
Return-to-Activity Timeline
The number of days required to resume work and/or sports will be documented.
Measured: Recorded at 3 and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start21 Apr 2025 (estimated)
- Primary completion21 Apr 2026 (estimated)
- Study completion21 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913894
- Sponsor's protocol ID
- DRFRecov2025-01
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06913894
- Acronym / sponsor ID
- DRFRecov2025-01
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 21 Apr 2026 (estimated)
- Study completion
- 21 Apr 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supervised Therapy Group (STG) | Experimental | Behavioral: Supervised Therapy for DRF RehabilitationParticipants 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). |
| Home-Based Program Group (HBG) | Experimental | Behavioral: Home-Based Rehabilitation Program for DRFParticipants perform a standardized home exercise program daily with weekly telephone or video follow-up (10 min sessions) over 6 weeks. |
| No Therapy Group (NTG) | Active comparator | Behavioral: Minimal Educational Intervention for DRFParticipants receive minimal instruction via a general educational brochure (e.g., "move your wrist as tolerated") without formal exercise supervision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Therapy for DRF RehabilitationParticipants 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. | Behavioural | Supervised Therapy Group (STG) |
| Home-Based Rehabilitation Program for DRFParticipants 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. | Behavioural | Home-Based Program Group (HBG) |
| Minimal Educational Intervention for DRFParticipants 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. | Behavioural | No Therapy Group (NTG) |
Primary outcome
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).
3 secondary outcomes
Wrist/Forearm Range of Motion (ROM)
Time frame: 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.
Return-to-Activity Timeline
Time frame: Recorded at 3 and 6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed ElMeligie, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Therapy for DRF Rehabilitation, Home-Based Rehabilitation Program for DRF and Minimal Educational Intervention for DRF in people with Distal Radius Fractures, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Zoheiry, Ph.D (01277774949 ext. +20, ibrahim.alzoheiry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (PRWE) Total Score (time frame: Assessed at 6 weeks (Cast-removal), 3 months, and 6 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.