- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01921062
Motor Imagery in Rehabilitation After a Distal Radius Fracture (MIDRF)
Kinesthetic Motor Imagery Training During Immobilization to Improve Wrist Functional Outcome After a Distal Radius Fracture in Women of 45-75 Years of Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: Distal radius fracture (DRF) is a common injury that may lead to prolonged function restrictions, decreased range of motion, reduced grip strength and pain. These symptoms may be caused by physical changes due to the injury and/or by the 4-6 weeks immobilization that is part of the conservative treatment. However, it might also be that neural changes during the immobilization play an important role. Such changes might be prevented by motor imagery training during the immobilization period. So, when neural changes are prevented, this may lead to a better functional outcome.
Objective: The objective is to improve the functional outcome in distal radius fracture patients, specified as an increase in function, dexterity, grip strength, range of motion, and decrease of pain.
Study design: Parallel group randomized controlled trial, with a post-test only control group design. Patients in the experimental group perform motor imagery training during the immobilization period, in addition to the regular treatment. Patients in the control group receive regular treatment.
Study population: Female DRF-patients who are conservatively treated by a cast, aged 45-75 years. The fracture must be a low energy trauma caused by a fall. Patients with a score higher than 72 on the Vividness of Motor Imagery Questionnaire (VMIQ) are excluded, as well as patients with co-morbidities that might influence the wrist function, or motor imagery-ability, and patients with no understanding of Dutch language. The patients are randomly allocated to the experimental or control group by restricted randomization to ensure equal group sizes.
Intervention: Motor imagery training during the immobilization period).
Main study parameters/endpoints: The main study parameter is function. Secondary study parameters are dexterity, range of motion, grip strength, and pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9700 RB
- University Medical Centre Groningen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- female patients
- non-comminutive distal radius fracture
- 45 to 75 years of age
Exclusion Criteria:
- distal radius fracture caused by HET
- comorbidities possibly influencing wrist function
- comorbidities possibly influencing motor imagery ability
- score higher than 72 on the Vividness of Motor Imagery Questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Patients allocated to the control group only receive standard treatment.
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Experimental: Motor imagery
Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period.
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The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand Function
Time Frame: 2 days after cast removal
|
Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale).
The score can range between 0 (no functional complaints) to 100 (unable to function)
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2 days after cast removal
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip Strength (Difference Unaffected - Affected)
Time Frame: 2 weeks after cast removal
|
Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms.
Grip and pinch strength of the non-affected hand were measured as reference.
The averages of three measurements were used in all analyses.
|
2 weeks after cast removal
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Dexterity
Time Frame: Directly after cast removal
|
Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale).
The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996).
The SODA consists of 12 tasks, and it takes 20 minutes to complete it.
The performance on the tasks is scored by the experimenter.
The score for each task is build up by two different components.
One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task.
For some tasks, only one hand is scored, while for other tasks both hands are scored.
The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996).
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Directly after cast removal
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Current Pain Level
Time Frame: Directly after cast removal
|
Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)
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Directly after cast removal
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Pain Relief
Time Frame: Directly after cast removal
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Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)
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Directly after cast removal
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Range of Motion
Time Frame: Directly after cast removal.
|
Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom).
ROM of the non-affected hand was also measured as reference.
|
Directly after cast removal.
|
Hand Function
Time Frame: 2 weeks after cast removal
|
Self-perceived hand function (construct) measured using the Patient Rated Wrist Hand Evaluation (PRWHE, scale).
The score can range between 0 (no functional complaints) to 100 (unable to function)
|
2 weeks after cast removal
|
Grip Strength
Time Frame: Directly after cast removal
|
Four different strength measurements were assessed; power grip, three-jaw chuck pinch, key pinch, and two-point pinch (Mathiowetz et al., 1984), using a digital Jamar dynamometer and pinch grip meter (H500 Hand Kit, Biometrics Ltd., Newport, United Kingdom), expressed in kilograms.
Grip and pinch strength of the non-affected hand were measured as reference.
The averages of three measurements were used in all analyses.
|
Directly after cast removal
|
Dexterity
Time Frame: 2 weeks after cast removal
|
Dexterity (construct) as measured using the Sequential Occupational Dexterity Assessment (SODA, scale).
The SODA is a valid and reliable instrument that measures bimanual dexterity during activities of daily living (van Lankveld et al. 1996).
The SODA consists of 12 tasks, and it takes 20 minutes to complete it.
The performance on the tasks is scored by the experimenter.
The score for each task is build up by two different components.
One component concerns how the task is performed, and the other component concerns the difficulty the patient experiences during the execution of the task.
For some tasks, only one hand is scored, while for other tasks both hands are scored.
The final score ranges from 0-108, where 0 means that the patient is unable to perform any of the tasks, and 108 means that all tasks were performed as requested without any difficulty (van Lankveld et al. 1996).
|
2 weeks after cast removal
|
Current Pain Level
Time Frame: 2 weeks after cast removal
|
Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)
|
2 weeks after cast removal
|
Pain Relief
Time Frame: 2 weeks after cast removal
|
Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)
|
2 weeks after cast removal
|
Range of Motion
Time Frame: 2 weeks after cast removal.
|
Active range of motion (flexion, extension, radial deviation, ulnar deviation, pronation and supination)(Gajdosik and Bohannon, 1987) was measured in degrees once using a digital goniometer (R500 Range of Motion Kit, Biometrics Ltd., Newport, United Kingdom).
ROM of the non-affected hand was also measured as reference.
|
2 weeks after cast removal.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin W. Stenekes, MD, PhD, University Medical Center Groningen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIDRF
- NL36638.042.11 (Other Identifier: Central Committee on Research Involving Human Subjects)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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