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Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture

Primary Purpose

Distal Radius Fracture, Pain

Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive Therapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ages between 18-65 years
  • diagnosed with DRFx which is extra-articular
  • managed with pins, internal fixation and/or cast

Exclusion Criteria:

  • unwilling or unable to participate
  • intra-articular and instable fractures containing other part of the fractures
  • fractures related with the malignancy and other neurologic diseases
  • existing inflammatory joint condition,
  • lack of cognitive function.

Sites / Locations

  • Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Therapy

Control

Arm Description

Graded motor imagery program was applied in only intervention group for 8 weeks.

Rehabilitation program applied in both groups for 8 weeks. Frequency of the treatment was 2 days in per week and its duration was approximately one hour in one session.

Outcomes

Primary Outcome Measures

Physical Function and Symptoms
Disability of the Arm, Shoulder and Hand (DASH) questionnaire scores range from 0 to 100 with a higher score indicating higher degree of disability.

Secondary Outcome Measures

Pain intensity
Visual Analog Scale (VAS) is used to evaluate pain intensity. The scale was consisted of a standard line labeled 0 on the left and 10 on the right. (0: no pain, 10: the worst pain).
Normal range of motion
Active range of motions of wrist regarding flexion, extension, ulnar deviation, radial deviation, supination and pronation were evaluated with universal goniometer and recorded as degree.
Grip Strength
Grip strength was measured in kilograms using a calibrated Jamar Hydraulic Hand Dynamometer with the elbow flexed to 90 degree.

Full Information

First Posted
July 11, 2016
Last Updated
July 15, 2016
Sponsor
Hacettepe University
Collaborators
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT02838446
Brief Title
Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture
Official Title
Cognitive Therapy Model: Graded Motor Imagery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Medipol University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was carried out on 36 patients. These patients were randomly assigned to two groups: classic treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week) physical therapy and rehabilitation intervention. Outcome measurements were based on upper extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale), range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation with goniometer), grip strength (standard grip strength with Jamar hydraulic hand dynamometer; lateral, palmar and pinch strength with pinch meter).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Therapy
Arm Type
Experimental
Arm Description
Graded motor imagery program was applied in only intervention group for 8 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Rehabilitation program applied in both groups for 8 weeks. Frequency of the treatment was 2 days in per week and its duration was approximately one hour in one session.
Intervention Type
Procedure
Intervention Name(s)
Cognitive Therapy
Other Intervention Name(s)
Rehabilitation
Intervention Description
Graded Motor Imagery has three stages: Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)
Primary Outcome Measure Information:
Title
Physical Function and Symptoms
Description
Disability of the Arm, Shoulder and Hand (DASH) questionnaire scores range from 0 to 100 with a higher score indicating higher degree of disability.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Visual Analog Scale (VAS) is used to evaluate pain intensity. The scale was consisted of a standard line labeled 0 on the left and 10 on the right. (0: no pain, 10: the worst pain).
Time Frame
8 weeks
Title
Normal range of motion
Description
Active range of motions of wrist regarding flexion, extension, ulnar deviation, radial deviation, supination and pronation were evaluated with universal goniometer and recorded as degree.
Time Frame
8 weeks
Title
Grip Strength
Description
Grip strength was measured in kilograms using a calibrated Jamar Hydraulic Hand Dynamometer with the elbow flexed to 90 degree.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages between 18-65 years diagnosed with DRFx which is extra-articular managed with pins, internal fixation and/or cast Exclusion Criteria: unwilling or unable to participate intra-articular and instable fractures containing other part of the fractures fractures related with the malignancy and other neurologic diseases existing inflammatory joint condition, lack of cognitive function.
Facility Information:
Facility Name
Medipol University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture

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