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

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ClinicalTrials.gov Identifier: NCT01921062
Recruitment Status : Recruiting
First Posted : August 13, 2013
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
D.C. Broekstra, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Behavioral: Motor imagery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: Motor imagery
The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.




Primary Outcome Measures :
  1. Hand function [ Time Frame: 2 days after cast removal ]
    Self-perceived hand function measured using the Patient Rated Wrist Hand Evaluation (PRWHE).


Other Outcome Measures:
  1. Grip strength [ Time Frame: 2 weeks after cast removal ]
    Four types of grip strength are measured: power grip strength, key-pinch grip strength, three-jaw pinch strength, two-point pinch strength.

  2. Dexterity [ Time Frame: Directly after cast removal ]
    Dexterity as measured using the Sequential Occupational Dexterity Assessment (SODA).

  3. Current pain level [ Time Frame: Directly after cast removal ]
    Current pain level, measured using a Visual Analogue Scale (VAS).

  4. Pain relief [ Time Frame: Directly after cast removal ]
    Current pain relief, measured using a Visual Analogue Scale (VAS).

  5. Range of Motion [ Time Frame: Directly after cast removal. ]
    Several ranges of motion of the wrist are measured: flexion-extension, ulnar-radial deviation, pronation-supination.

  6. Hand function [ Time Frame: 2 weeks after cast removal ]
    Self-perceived hand function measured using the Patient Rated Wrist Hand Evaluation (PRWHE).

  7. Grip strength [ Time Frame: Directly after cast removal ]
    Four types of grip strength are measured: power grip strength, key-pinch grip strength, three-jaw pinch strength, two-point pinch strength.

  8. Dexterity [ Time Frame: 2 weeks after cast removal ]
    Dexterity as measured using the Sequential Occupational Dexterity Assessment (SODA).

  9. Current pain level [ Time Frame: 2 weeks after cast removal ]
    Current pain level, measured using a Visual Analogue Scale (VAS).

  10. Pain relief [ Time Frame: 2 weeks after cast removal ]
    Current pain relief, measured using a Visual Analogue Scale (VAS).

  11. Range of Motion [ Time Frame: 2 weeks after cast removal. ]
    Several ranges of motion of the wrist are measured: flexion-extension, ulnar-radial deviation, pronation-supination.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921062


Contacts
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Contact: Dieuwke C. Broekstra, MSc +31503611945 d.c.broekstra@umcg.nl
Contact: Martin W. Stenekes, MD, PhD +31503614844 m.w.stenekes@umcg.nl

Locations
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Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Martin W. Stenekes, MD, PhD University Medical Center Groningen

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Responsible Party: D.C. Broekstra, MSc, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01921062     History of Changes
Other Study ID Numbers: MIDRF
NL36638.042.11 ( Other Identifier: Central Committee on Research Involving Human Subjects (CCMO) )
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by D.C. Broekstra, University Medical Center Groningen:
Distal radius fracture
Motor imagery
Immobilisation
Effectivity

Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries