- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02838446
Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture
July 15, 2016 updated by: Burcu Dilek, Hacettepe University
Cognitive Therapy Model: Graded Motor Imagery
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Medipol University
-
-
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
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Cognitive Therapy
Graded motor imagery program was applied in only intervention group for 8 weeks.
|
Graded Motor Imagery has three stages: Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)
Other Names:
|
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Active Comparator: Control
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.
|
Graded Motor Imagery has three stages: Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Function and Symptoms
Time Frame: 8 weeks
|
Disability of the Arm, Shoulder and Hand (DASH) questionnaire scores range from 0 to 100 with a higher score indicating higher degree of disability.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 8 weeks
|
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).
|
8 weeks
|
|
Normal range of motion
Time Frame: 8 weeks
|
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.
|
8 weeks
|
|
Grip Strength
Time Frame: 8 weeks
|
Grip strength was measured in kilograms using a calibrated Jamar Hydraulic Hand Dynamometer with the elbow flexed to 90 degree.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
January 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 11, 2016
First Submitted That Met QC Criteria
July 15, 2016
First Posted (Estimate)
July 20, 2016
Study Record Updates
Last Update Posted (Estimate)
July 20, 2016
Last Update Submitted That Met QC Criteria
July 15, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 14/06
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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