Motor Imagery in Rehabilitation After a Distal Radius Fracture (MIDRF)

July 5, 2023 updated by: D.C. Broekstra, University Medical Center Groningen

Kinesthetic Motor Imagery Training During Immobilization to Improve Wrist Functional Outcome After a Distal Radius Fracture in Women of 45-75 Years of Age

The aim of this study is to determine whether motor imagery training during the immobilisation period in patients with a distal radius fracture, results in an improved functional outcome compared to patients who do not perform motor imagery.

Study Overview

Status

Terminated

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

Interventional

Enrollment (Actual)

66

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 Locations

      • Groningen, Netherlands, 9700 RB
        • University Medical Centre Groningen

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients allocated to the control group only receive standard treatment.
Experimental: Motor imagery
Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period.
The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.

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)
2 days after cast removal

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
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).
Directly after cast removal
Current Pain Level
Time Frame: Directly after cast removal
Current pain level, measured using a Visual Analogue Scale (VAS), 0 (best) - 100 (worst)
Directly after cast removal
Pain Relief
Time Frame: Directly after cast removal
Current pain relief, measured using a Visual Analogue Scale (VAS), 0 (worst) - 100 (best)
Directly after cast removal
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

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

Investigators

  • Principal Investigator: Martin W. Stenekes, MD, PhD, University Medical Center Groningen

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.

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 (Actual)

July 1, 2011

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimated)

August 13, 2013

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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)?

NO

IPD Plan Description

No plan currently available, but we are open for collaborations.

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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