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

Primary Purpose

Distal Radius Fracture

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Motor imagery
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture, Motor imagery, Immobilisation, Effectivity

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Centre Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Motor imagery

Arm Description

Patients allocated to the control group only receive standard treatment.

Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period.

Outcomes

Primary Outcome Measures

Hand function
Self-perceived hand function measured using the Patient Rated Wrist Hand Evaluation (PRWHE).

Secondary Outcome Measures

Full Information

First Posted
August 7, 2013
Last Updated
February 9, 2022
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01921062
Brief Title
Motor Imagery in Rehabilitation After a Distal Radius Fracture
Acronym
MIDRF
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Severe difficulties with recruiting participants
Study Start Date
July 2011 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal radius fracture, Motor imagery, Immobilisation, Effectivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients allocated to the control group only receive standard treatment.
Arm Title
Motor imagery
Arm Type
Experimental
Arm Description
Patients allocated to this arm perform kinesthetic motor imagery during the immobilisation period.
Intervention Type
Behavioral
Intervention Name(s)
Motor imagery
Intervention Description
The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.
Primary Outcome Measure Information:
Title
Hand function
Description
Self-perceived hand function measured using the Patient Rated Wrist Hand Evaluation (PRWHE).
Time Frame
2 days after cast removal
Other Pre-specified Outcome Measures:
Title
Grip strength
Description
Four types of grip strength are measured: power grip strength, key-pinch grip strength, three-jaw pinch strength, two-point pinch strength.
Time Frame
2 weeks after cast removal
Title
Dexterity
Description
Dexterity as measured using the Sequential Occupational Dexterity Assessment (SODA).
Time Frame
Directly after cast removal
Title
Current pain level
Description
Current pain level, measured using a Visual Analogue Scale (VAS).
Time Frame
Directly after cast removal
Title
Pain relief
Description
Current pain relief, measured using a Visual Analogue Scale (VAS).
Time Frame
Directly after cast removal
Title
Range of Motion
Description
Several ranges of motion of the wrist are measured: flexion-extension, ulnar-radial deviation, pronation-supination.
Time Frame
Directly after cast removal.
Title
Hand function
Description
Self-perceived hand function measured using the Patient Rated Wrist Hand Evaluation (PRWHE).
Time Frame
2 weeks after cast removal
Title
Grip strength
Description
Four types of grip strength are measured: power grip strength, key-pinch grip strength, three-jaw pinch strength, two-point pinch strength.
Time Frame
Directly after cast removal
Title
Dexterity
Description
Dexterity as measured using the Sequential Occupational Dexterity Assessment (SODA).
Time Frame
2 weeks after cast removal
Title
Current pain level
Description
Current pain level, measured using a Visual Analogue Scale (VAS).
Time Frame
2 weeks after cast removal
Title
Pain relief
Description
Current pain relief, measured using a Visual Analogue Scale (VAS).
Time Frame
2 weeks after cast removal
Title
Range of Motion
Description
Several ranges of motion of the wrist are measured: flexion-extension, ulnar-radial deviation, pronation-supination.
Time Frame
2 weeks after cast removal.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin W. Stenekes, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan currently available, but we are open for collaborations.
Citations:
PubMed Identifier
35102780
Citation
Broekstra DC, Mouton LJ, van der Sluis CK, IJpma FFA, Stenekes MW. Hand function in patients with distal radius factures after home-based kinaesthetic motor imagery training. J Hand Surg Eur Vol. 2022 Jun;47(6):656-658. doi: 10.1177/17531934221075945. Epub 2022 Feb 1. No abstract available.
Results Reference
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Motor Imagery in Rehabilitation After a Distal Radius Fracture

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