- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937232
Mirrored Movement Compared to Cross-education
Mirrored Movement Compared to Cross-education for Recovery After Hand or Wrist Injury: a Pilot Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
When someone has an injury to the hand or wrist, often the person's doctor and therapists will ask them to use a cast or a splint to protect the body while it heals. They also may ask the person not to do certain movements, or any activities where it is necessary to use the hand for squeezing or gripping. This is important to allow healing, but the injured arm can become weaker during this period. New research has demonstrated that performing specific forms of exercise on the uninjured side can help speed recovery on the injured side, even when the injured hand is still in a cast.
Two of these types of exercise are called cross-education and mirror visual feedback. Cross-education means doing resistance or strengthening exercises on the uninjured side while the injured side is resting. Mirror visual feedback is performing exercise or movements with the uninjured hand in front of a mirror, hiding the injured hand resting behind the mirror, so it looks like the injured hand is doing the exercises too. The investigators think both of these exercises work because they use the same part of the brain, part of our movement control network that helps us coordinate movements on both sides of the body. Perhaps they might work even better if used together.
This study will test cross-education, mirror visual feedback or cross-education combined with mirror visual feedback added to the usual therapy after a hand or wrist injury. The investigators need to be sure that this is better than usual care, so some people who participate in the study will just have the usual care, and not do any extra exercise. Because limited research has been done on these methods after injury, this will be a small study to test the best ways to run a big study that will provide solid proof about these ideas. That means the investigators will ask participants to keep track of how often they do their exercises, and to tell the study team about any problems or concerns they have when they are doing their exercises.
If it can be demonstrated that cross-exercise and/or mirror visual feedback can speed up or improve recovery after a hand or wrist injury, it might help participants get back to work and their usual activities faster and with less pain. These treatments don't cost a lot of money or need a lot of special equipment, so they could be used in many different countries. If the study can show these exercises help with hand and wrist injuries, they might also be able to be used for therapy after stroke, or with other kinds of injuries like foot and ankle fractures.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tara Packham, PhD
- Phone Number: 27812 9055259140
- Email: packhamt@mcmaster.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 16 or older
- Acute injury to one hand or wrist requiring protection or immobilization, including fractures (managed conservatively or with surgery), tendon laceration/repairs, burns, and/or ligament injuries/repairs
- Able to provide informed consent
Exclusion Criteria:
- Unable to complete study questionnaires in English
- Traumatic injuries to other limbs or axial skeleton (e.g. whiplash, rib fracture, concurrent lower limb injury)
- Anticipates difficulty to return for follow-up visits (i.e. out of catchment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cross-Education
Cross education has been defined as the unilateral training of a limb with resisted exercise for the benefit of transferring strength to the contralateral (often injured or immobilized) limb.
Participants randomized to cross-education will be provided with a hand-grip strengthener, adjusted to provide resistance at 70-80% of their maximum grip strength.
They will be given written, illustrated instructions for performing grip strengthening exercises for their uninjured hand in a seated position with both forearms comfortably supported; this will be demonstrated during the teaching session.
The instructions will ask for the participant to complete 3 sets of 10 repetitions twice daily, with additional instructions for appropriate grading of resistance.
A diary for tracking exercise completion and attendance for usual care will also be provided.
|
Home exercise program + usual care
Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
|
Active Comparator: Mirror Visual Feedback
Mirror visual feedback is the performance of movements with an uninjured hand in front of a mirror hiding the injured hand, thus creating the illusion of bilateral movement.
Participants randomized to mirror visual feedback will be provided with a portable mirror and stand, and instructed with accompanying demonstration on how to set up on a table for comfortable visualization.
They will be given written, illustrated instructions for performing mirror visualization of exercises completed by the uninjured hand only from a position of neutral rotation of the forearm.
The instructions will ask for the participant to complete a three sets of 10 repetitions for finger flexion and extension (mimicking the fisting motion of the grip strengthening exercises) twice daily.
A diary for tracking exercise completion and attendance for usual care will also be provided.
|
Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
Home exercise program + usual care
|
Experimental: Cross-education + Mirror Visual Feedback
In this group, participants will perform the cross-education resistance exercise in front of the mirror, visualizing the performance of the resistance exercises.
Participants randomized to cross education with mirror visual feedback will be provided with both a hand-grip strengthener and a portable mirror and stand, and instructed with accompanying demonstration on how to set up on a table for comfortable visualization.
They will be given written, illustrated instructions for performing mirror visualization hand grip strengthening exercises completed by the uninjured hand only from a position of neutral rotation of the forearm.
The instructions will ask for the participant to complete 3 sets of 10 repetitions twice daily, with additional instructions for appropriate grading of resistance.
A diary for tracking exercise completion and attendance for usual care will also be provided.
|
Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
Home exercise program + usual care
|
Active Comparator: Usual Care
Participants randomized to usual care will be encouraged to attend the recommended rehabilitation, and provided with a diary for frequency of rehab attendance, and tracking any exercises completed at home.
|
Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trial feasibility
Time Frame: 3 months
|
total number of potential participants vs. enrolled participants from the clinic
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite finger flexion
Time Frame: 1, 2, and 3 months
|
the distance (in cm) from the junction of the nail fold on the fingertip to the distal palmar crease on the hand for the index, middle, ring and small fingers
|
1, 2, and 3 months
|
Patient-Rated Wrist and Hand Evaluation
Time Frame: 1,2,and 3 months
|
This patient self report measure is scored from 0-100 across two subscales containing 15 items addressing pain and disability in the hand and wrist.
Higher scores indicate more pain and disability.
|
1,2,and 3 months
|
Pain Catastrophizing Scale
Time Frame: 3 months
|
This patient self-report measure contains 14 items addressing negative pain beliefs.
It is scored from 0-52, with a score of over 30 considered to represent unhelpful beliefs about pain.
|
3 months
|
Hand grip strength
Time Frame: 3 months
|
Grip strength as measured by hand dynamometer (in kilos).
|
3 months
|
Adverse events
Time Frame: 3 months
|
Number of major adverse events defined as need for secondary surgical intervention
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5979
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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