Distal Radius FractureMIDRFNCT01921062
Motor Imagery in Rehabilitation After a Distal Radius Fracture
A study testing Motor imagery in people with Distal Radius Fracture, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients
- non-comminutive distal radius fracture
- 45 to 75 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Motor imagery
- Keywords
- Distal radius fracture, Motor imagery, Immobilisation, Effectivity
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imageryBehavioural
The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 days after cast removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJul 2011
- Primary completion31 Oct 2019
- Study completion15 Dec 2020
Why it stopped: Severe difficulties with recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.C. Broekstra, University Medical Center Groningen
- Investigators
- Martin W. Stenekes, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921062
- Sponsor's protocol ID
- MIDRF
- Other IDs
- NL36638.042.11
- Acronym
- MIDRF
- Status last verified
- Jul 2023
- First submitted
- 7 Aug 2013
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan currently available, but we are open for collaborations.
Publications
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.
PubMed 35102780
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01921062
- Acronym / sponsor ID
- MIDRF / MIDRF
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture, Motor imagery, Immobilisation, Effectivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Severe difficulties with recruiting participants
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 21 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients allocated to the control group only receive standard treatment. |
| Motor imagery | Experimental | Behavioral: Motor imageryPatients allocated to this arm perform kinesthetic motor imagery during the immobilisation period. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients
- non-comminutive distal radius fracture
- 45 to 75 years of age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor imageryThe kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist. | Behavioural | Motor imagery |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35102780Broekstra 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.
- Individual participant dataSharing planned: No. No plan currently available, but we are open for collaborations.
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin W. Stenekes, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery in people with Distal Radius Fracture, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Function (time frame: 2 days after cast removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01921062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.