NCT07756619

Brief Summary

Distal radius fractures (DRFs) are fractures affecting the wrist and occurring in the distal portion of the radius bone. DRFs can also be classified as Colles, Barton, Smith, and Hutchinson/Chauffeur fractures according to the characteristics of the fracture. The incidence of these fractures shows a bimodal distribution. In young adults, distal radius fractures occur more often as a result of high-energy traumas (e.g., traffic accidents or impacts during contact sports), while in older adults, especially during winter months, low-energy falls from standing height (falling onto an outstretched hand) are a more common cause.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Wrist Fracturespaindistal radius fractureselectrotherapy

Outcome Measures

Primary Outcomes (8)

  • Visual analog scale

    A visual analog scale will be used to evaluate the patients' current pain severity. This scale is one of the frequently preferred scales to evaluate the pain intensity of patients during rest, activity and night. The scale has a 10 cm long line where the patient can mark the intensity of pain. The patient will be asked to indicate the degree of pain intensity between no pain (left part) and unbearable pain (right part) of the line.

    Baseline

  • Visual analog scale

    A visual analog scale will be used to evaluate the patients' current pain severity. This scale is one of the frequently preferred scales to evaluate the pain intensity of patients during rest, activity and night. The scale has a 10 cm long line where the patient can mark the intensity of pain. The patient will be asked to indicate the degree of pain intensity between no pain (left part) and unbearable pain (right part) of the line.

    4th week

  • Edema

    Edema measurement will be done using a thin measuring tape, measuring in figure-eight increments, and recorded in centimeters.

    Baseline

  • Edema

    Edema measurement will be done using a thin measuring tape, measuring in figure-eight increments, and recorded in centimeters.

    4th week

  • Grip Strength

    The Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and considered the gold standard due to its high validity and reliability in numerous studies, will be used to measure hand grip strength. Hand grip strength will be measured in the standard position recommended by the AETD: seated, with shoulder adduction and neutral rotation, elbow 90 degrees flexion, forearm mid-rotation and supported, and wrist in neutral position. According to the test procedure, three consecutive measurements of hand grip strength will be taken, and the averages will be recorded in kilograms.

    Baseline

  • Grip Strength

    The Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and considered the gold standard due to its high validity and reliability in numerous studies, will be used to measure hand grip strength. Hand grip strength will be measured in the standard position recommended by the AETD: seated, with shoulder adduction and neutral rotation, elbow 90 degrees flexion, forearm mid-rotation and supported, and wrist in neutral position. According to the test procedure, three consecutive measurements of hand grip strength will be taken, and the averages will be recorded in kilograms.

    4th week

  • Pinch Strength

    Pinch strength measurement will be performed in the standard position recommended by AETD; sitting position, shoulder in adduction and neutral rotation, elbow 90 degrees flexion, forearm in mid-rotation and supported, wrist in neutral position. According to the test procedure, 3 consecutive measurements will be taken for pinch strength and the averages will be recorded in kg.

    Baseline

  • Pinch Strength

    Pinch strength measurement will be performed in the standard position recommended by AETD; sitting position, shoulder in adduction and neutral rotation, elbow 90 degrees flexion, forearm in mid-rotation and supported, wrist in neutral position. According to the test procedure, 3 consecutive measurements will be taken for pinch strength and the averages will be recorded in kg.

    4th week

Secondary Outcomes (2)

  • Patient-Reported Wrist Assessment Questionnaire

    Baseline

  • Patient-Reported Wrist Assessment Questionnaire

    4th week

Study Arms (2)

Traditional Treatment

ACTIVE COMPARATOR

Individuals in this group will undergo passive, active-assisted, and active hand and wrist joint exercises. The exercises will be tailored to protocols reported as safe and effective in the literature.

Other: Traditional Exercises

Neuromuscular Stimulation

EXPERIMENTAL

Individuals in this group will receive neuromuscular stimulation in addition to the Traditional Treatment protocol.

Other: Traditional ExercisesOther: Neuromuscular Stimulation

Interventions

active joint movements of the hand and wrist, passive, active-assisted and active stretching exercises

Neuromuscular StimulationTraditional Treatment

Neuromuscular stimulation will be applied to the m. flexor digitorum superficialis and m. flexor digitorum profundus muscles.

Neuromuscular Stimulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent open reduction and volar plate surgery due to distal radius fracture (DRF) evaluated with plain radiography and CT scans.

You may not qualify if:

  • Polytrauma
  • Surgical intervention other than volar plate
  • History of surgery on the affected extremity
  • Injury to multiple anatomical sites in the affected extremity
  • Hemiplegia or contracture in the affected extremity
  • Major complications such as postoperative neurovascular injury and hematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Horoz L, Karacay BC, Ceylan I, Cakmak MF. Is home-based real-time video conferencing telerehabilitation as effective as conventional face-to-face rehabilitation in patients with operated for distal radius fracture? A single-blind, randomized prospective study. Turk J Phys Med Rehabil. 2024 Apr 26;70(4):506-516. doi: 10.5606/tftrd.2024.13739. eCollection 2024 Dec.

    PMID: 40028408BACKGROUND
  • Cigdem-Karacay B, Horoz L, Ceylan I, Alkan H. Effectiveness of instrument-assisted soft tissue mobilization in patients operated for distal radius fracture: A randomized controlled blinded clinical study. J Hand Ther. 2026 Jan-Mar;39(1):236-244. doi: 10.1016/j.jht.2025.05.009. Epub 2025 Jul 5.

    PMID: 40619299BACKGROUND
  • Cigdem-Karacay B, Horoz L, Ceylan I, Alkan H. The effectiveness of dry heat treatment (fluidotherapy) in patients with distal radius fracture followed conservatively: a single-blinded, randomized controlled clinical study. Rev Assoc Med Bras (1992). 2025 Dec 8;71(11):e20250806. doi: 10.1590/1806-9282.20250806. eCollection 2025.

    PMID: 41370488BACKGROUND

MeSH Terms

Conditions

Wrist FracturesPain

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Basak Cigdem Karacay, Assoc Prof

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Cigdem Karacay, Assoc Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor is unaware of the groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share