NCT06894485

Brief Summary

This randomized controlled trial examines the effectiveness of sensory training in patients undergoing rehabilitation for distal radius fractures. Forty-four participants (aged 18-65, with no prior upper extremity injuries) will be randomly assigned to a control group (conventional physiotherapy) or an experimental group (conventional physiotherapy plus sensory training, including desensitization and proprioception exercises). Assessments will be conducted at baseline, 4 weeks, and 8 weeks using grip strength, sensory function, fine motor skills, pain level, and functional capacity measures. The study aims to compare the impact of sensory training versus conventional physiotherapy on pain reduction, sensory recovery, grip strength, and functional hand use.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 19, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

Distal Radius FracturesSensoryPhysiotherapyRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Monofilament Test

    The monofilament test is a clinical assessment method used to evaluate sensory function and detect peripheral nerve damage. It is widely used in physiotherapy and neurology to measure tactile sensitivity and identify sensory impairments. 1. The patient is comfortably seated, and the test area is exposed. 2. Applying the monofilament: * The monofilament is placed perpendicularly to the skin surface. * It is gently pressed until it reaches its bending point (held for approximately 1-2 seconds). 3. Patient response: The patient is asked to indicate when they feel the touch. 4. Recording results: The areas where the patient does or does not feel the stimulus are noted, creating a sensory map.

    on the first day, four and eight week change

  • Numerical Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a measurement method based on the patient's numerical expression of pain. It is commonly used to determine the intensity of pain and track changes during the treatment process. Test Procedure Explaining the Scale to the Patient: A scale ranging from 0 to 10 is shown to the patient. 0 = No pain, 10 = The most intense pain imaginable. The patient is asked to choose the number that best represents their current pain.

    on the first day, four and eight week change

Secondary Outcomes (3)

  • Grip Strength

    on the first day, four and eight week change

  • Nine-Hole Peg Test

    on the first day, four and eight week change

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    on the first day, four and eight week change

Study Arms (2)

Control

EXPERIMENTAL

* Conventional range of motion (ROM) exercises * Muscle strengthening exercises * Fine motor skill exercises * Functional rehabilitation exercises The group will be followed 3 times per week for 8 weeks.

Other: Conventional therapy

Experimental

EXPERIMENTAL

* Conventional range of motion (ROM) exercises * Muscle strengthening exercises * Fine motor skill exercises * Functional rehabilitation exercises • Experimental Group: (Conventional therapy + Sensory Training) * Desensitization training (exposure to various textures and stimuli to improve sensory tolerance) * Proprioceptive exercises (closed-eye position sense training, weight transfer exercises) * Tactile stimulation The group will be followed 3 times per week for 8 weeks.

Other: Conventional therapyOther: Sensory Training

Interventions

* Conventional range of motion (ROM) exercises * Muscle strengthening exercises * Fine motor skill exercises * Functional rehabilitation exercises

ControlExperimental

* Desensitization training (exposure to various textures and stimuli to improve sensory tolerance) * Proprioceptive exercises (closed-eye position sense training, weight transfer exercises) * Tactile stimulation

Experimental

Eligibility Criteria

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

You may qualify if:

  • Aged 18-65 years
  • Diagnosed with distal radius fracture
  • In the rehabilitation phase after fracture healing
  • No prior upper extremity injuries
  • No neurological or psychiatric disorders affecting hand function
  • Able to comply with the rehabilitation program

You may not qualify if:

  • Any other musculoskeletal injury affecting the upper limb
  • Previous upper extremity surgeries
  • Severe neuropathy or sensory disorders
  • Uncontrolled chronic pain conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Muurling M, Lotters FJB, Geelen JE, Schouten AC, Mugge W. A long-term effect of distal radius fracture on the sensorimotor control of the wrist joint in older adults. J Hand Ther. 2021 Oct-Dec;34(4):567-576. doi: 10.1016/j.jht.2020.07.002. Epub 2020 Jul 29.

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

TUGBA CIVI KARAASLAN, Asst. Prof. Dr.

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 25, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations