NCT01921062

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

July 1, 2023

Enrollment Period

8.3 years

First QC Date

August 7, 2013

Results QC Date

July 26, 2022

Last Update Submit

July 5, 2023

Conditions

Keywords

Distal radius fractureMotor imageryImmobilisationEffectivity

Outcome Measures

Primary Outcomes (1)

  • Hand Function

    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 Outcomes (11)

  • Grip Strength (Difference Unaffected - Affected)

    2 weeks after cast removal

  • Dexterity

    Directly after cast removal

  • Current Pain Level

    Directly after cast removal

  • +8 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Patients allocated to the control group only receive standard treatment.

Motor imagery

EXPERIMENTAL

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

Behavioral: Motor imagery

Interventions

Motor imageryBEHAVIORAL

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

Motor imagery

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients
  • non-comminutive distal radius fracture
  • to 75 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Limitations and Caveats

The SODA scores appeared to be very much influenced by hand dominance, because of the nature of the activities assessed in the SODA. We therefore decided not to statistically test the SODA scores, but only provide descriptive statistics.

Results Point of Contact

Title
Dieuwke Broekstra, PhD; postdoctoral researcher
Organization
University Medical Center Groningen

Study Officials

  • Martin W. Stenekes, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 13, 2013

Study Start

July 1, 2011

Primary Completion

October 31, 2019

Study Completion

December 15, 2020

Last Updated

February 21, 2024

Results First Posted

February 21, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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

Locations