Sensory Training in Distal Radius Fractures

March 19, 2025 updated by: Tugba Civi Karaaslan, Istanbul University

Effectiveness of Sensory Training in Distal Radius Fractures: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the effectiveness of sensory training in patients with distal radius fractures. Designed as a randomized controlled trial, the study will include 44 participants aged 18-65 years who have not had a prior upper extremity injury and are in the rehabilitation phase after a fracture. Participants will be randomly assigned to either the control group (receiving conventional physiotherapy) or the experimental group (receiving conventional physiotherapy plus sensory training, including desensitization and proprioception exercises).

Assessments will be conducted before treatment, at 4 weeks, and at 8 weeks. The evaluation tools will include grip strength (hand dynamometer & pinch meter), sensory function (monofilament test), fine motor skills (Nine-Hole Peg Test - NHPT), pain level (Numerical Pain Rating Scale - NPRS), and functional capacity (DASH questionnaire).

The aim of this study is to compare the effects of sensory training versus conventional physiotherapy on pain reduction, sensory recovery, grip strength, and functional hand use.

Study Type

Interventional

Enrollment (Estimated)

44

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 Locations

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:

  • 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

Exclusion Criteria:

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

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: Control
  • 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
  • Conventional range of motion (ROM) exercises
  • Muscle strengthening exercises
  • Fine motor skill exercises
  • Functional rehabilitation exercises
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 therapy
  • Conventional range of motion (ROM) exercises
  • Muscle strengthening exercises
  • Fine motor skill exercises
  • Functional rehabilitation exercises
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monofilament Test
Time Frame: on the first day, four and eight week change

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
Time Frame: on the first day, four and eight week change

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: on the first day, four and eight week change

Hand Dynamometer: The hand dynamometer is a device used to measure hand grip strength and is commonly used in the evaluation of hand functions.

  • The device is placed on a stable surface and calibrated to ensure accurate measurement.
  • The patient should sit or stand in a comfortable position, with the elbow typically bent at a 90-degree angle.
  • The patient holds the dynamometer and is asked to squeeze the handle.

Pinch Meter: Pincer Meter is a device used to measure the strength of a pinching or gripping action, typically between the thumb and index finger.

  • The patient should be seated comfortably or standing, with their elbow typically at a 90-degree angle.
  • The device measures the force exerted between the thumb and index finger.
  • The test will repeat three times, and the highest value is recorded.
on the first day, four and eight week change
Nine-Hole Peg Test
Time Frame: on the first day, four and eight week change

Nine-Hole Peg Test (9-HPT) is a test used to assess hand function, fine motor skills, and hand coordination. It is commonly used in neurological conditions, hand injuries, and rehabilitation processes.

Procedure:

  1. Preparation: A pegboard with 9 holes is placed on a flat surface, with a peg in each hole. The patient sits comfortably, and the test is performed on one hand at a time.

  2. Test Execution:

    • Starting Position: The patient prepares by looking at the pegs placed in the starting position.
    • Placing the Pegs: The patient is instructed to pick up each peg and place it into the holes one by one.
    • Test Duration: The time taken to place and remove the pegs is recorded. The test is repeated on both hands.
  3. Results Evaluation: At the end of the test, the total time taken is recorded and used to evaluate hand function. The test is typically repeated three times, and the average time is calculated.
on the first day, four and eight week change
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time Frame: on the first day, four and eight week change

The DASH Scale (Disabilities of the Arm, Shoulder, and Hand) is a widely used and valid questionnaire for assessing upper extremity function.

The DASH scale consists of 30 questions. These questions cover the difficulties patients experience with arm, shoulder, and hand functions, the level of pain they experience, and any difficulties they encounter in daily activities. Additionally, a 5-point Likert scale is used to assess the severity of the complaints (1 = no difficulty, 5 = very difficult).

Each response is scored, and a total result is obtained. The scores are then evaluated on a scale of 0-100. Lower scores indicate less disability, while higher scores indicate greater functional impairment.

Evaluation: The results are used to assess the patient's overall functional status and their response to treatment. Higher scores indicate significant difficulties with upper extremity function.
on the first day, four and eight week change

Collaborators and Investigators

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

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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