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
About this trial
This is an interventional treatment trial for Distal Radius Fracture
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.
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
NCT ID
NCT02838446
First Posted
July 11, 2016
Last Updated
July 15, 2016
Sponsor
Hacettepe University
Collaborators
Medipol University
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
Learn more about this trial
Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture
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