Hand InjuriesNCT03937232
Mirrored Movement Compared to Cross-education
A study testing Cross-Education and Mirror Visual Feedback in people with Hand Injuries, run by McMaster University.
Trial summary
Recovery after a hand or wrist injury often includes wearing a cast, or limiting daily activities to help with healing, but this may lead to deconditioning. Previous research suggests resistance training with the healthy arm during this period could help improve recovery of the injured arm: this is called… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Cross-Education and Mirror Visual Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mirrored Movement Compared to Cross-education for Recovery After Hand or Wrist Injury: a Pilot Study.
Recovery after a hand or wrist injury often includes wearing a cast, or limiting daily activities to help with healing, but this may lead to deconditioning. Previous research suggests resistance training with the healthy arm during this period could help improve recovery of the injured arm: this is called cross-education. Mirror visual feedback (e.g. watching the movement of an uninjured hand in front of a mirror hiding the injured hand to create the illusion both hands are moving) is another cross-body method which can improve recovery after stroke, and prevent or reduce pain in complex regional pain syndrome. Both of these treatments may work because they activate a specific area in the brain: using them together might strengthen the effects. However, this has never been studied after injury. The investigators are proposing a pilot study to see if it is possible and helpful to use these treatments in combination to improve recovery of grip strength and reduction of pain and disability. The investigators will use this information as a foundation to tell us how to run the best study to test these ideas in ways to be confident in the results.
Read the 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.
- Conditions
- Hand Injuries
- Being tested
- Cross-Education, Mirror Visual Feedback, Usual care
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-EducationBehavioural
Home exercise program + usual care
Mirror Visual FeedbackBehavioural
Home exercise program + usual care
Usual careOther
Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
| Study group | Role | What they receive |
|---|---|---|
| Cross-Education | Active comparator | 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. Receives: Behavioral: Cross-Education; Other: Usual care |
| Mirror Visual Feedback | Active comparator | 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. Receives: Behavioral: Mirror Visual Feedback; Other: Usual care |
| Cross-education + Mirror Visual Feedback | Experimental | 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. Receives: Behavioral: Mirror Visual Feedback; Other: Usual care |
| Usual Care | Active comparator | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility
total number of potential participants vs. enrolled participants from the clinic
Measured: 3 months
Secondary outcomes (5)
Composite finger flexion
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
Measured: 1, 2, and 3 months
Patient-Rated Wrist and Hand Evaluation
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.
Measured: 1,2,and 3 months
Pain Catastrophizing Scale
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.
Measured: 3 months
Hand grip strength
Grip strength as measured by hand dynamometer (in kilos).
Measured: 3 months
Adverse events
Number of major adverse events defined as need for secondary surgical intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Factorial
- Model description
- Cross-education OR Mirror visual feedback OR Cross-education + mirror visual feedback OR usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara Packham, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937232
- Sponsor's protocol ID
- 5979
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Green LA, Gabriel DA. The cross education of strength and skill following unilateral strength training in the upper and lower limbs. J Neurophysiol. 2018 Aug 1;120(2):468-479. doi: 10.1152/jn.00116.2018. Epub 2018 Apr 18.
PubMed 29668382
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirrored Movement Compared to Cross-education for Recovery After Hand or Wrist Injury: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03937232
- Acronym / sponsor ID
- 5979
- Conditions
- Hand Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recovery after a hand or wrist injury often includes wearing a cast, or limiting daily activities to help with healing, but this may lead to deconditioning. Previous research suggests resistance training with the healthy arm during this period could help improve recovery of the injured arm: this is called cross-education. Mirror visual feedback (e.g. watching the movement of an uninjured hand in front of a mirror hiding the injured hand to create the illusion both hands are moving) is another cross-body method which can improve recovery after stroke, and prevent or reduce pain in complex regional pain syndrome. Both of these treatments may work because they activate a specific area in the brain: using them together might strengthen the effects. However, this has never been studied after injury. The investigators are proposing a pilot study to see if it is possible and helpful to use these treatments in combination to improve recovery of grip strength and reduction of pain and disability. The investigators will use this information as a foundation to tell us how to run the best study to test these ideas in ways to be confident in the results.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Cross-education OR Mirror visual feedback OR Cross-education + mirror visual feedback OR usual care
| Arm | Type | Receives |
|---|---|---|
| Cross-Education | Active comparator | Behavioral: Cross-Education, Other: Usual careCross 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. |
| Mirror Visual Feedback | Active comparator | Behavioral: Mirror Visual Feedback, Other: Usual careMirror 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. |
| Cross-education + Mirror Visual Feedback | Experimental | Behavioral: Mirror Visual Feedback, Other: Usual careIn 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. |
| Usual Care | Active comparator | Other: Usual careParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Cross-EducationHome exercise program + usual care | Behavioural | Cross-Education |
| Mirror Visual FeedbackHome exercise program + usual care | Behavioural | Cross-education + Mirror Visual Feedback, Mirror Visual Feedback |
| Usual careHand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting | Other | Cross-Education, Cross-education + Mirror Visual Feedback, Mirror Visual Feedback, Usual Care |
Primary outcome
Trial feasibility
Time frame: 3 months
total number of potential participants vs. enrolled participants from the clinic
5 secondary outcomes
Composite finger flexion
Time frame: 1, 2, and 3 months
Patient-Rated Wrist and Hand Evaluation
Time frame: 1,2,and 3 months
Pain Catastrophizing Scale
Time frame: 3 months
Hand grip strength
Time frame: 3 months
Adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Background: PubMed 29668382Green LA, Gabriel DA. The cross education of strength and skill following unilateral strength training in the upper and lower limbs. J Neurophysiol. 2018 Aug 1;120(2):468-479. doi: 10.1152/jn.00116.2018. Epub 2018 Apr 18.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-Education and Mirror Visual Feedback in people with Hand Injuries, run by McMaster University.
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 3 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: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tara Packham, PhD (9055259140 ext. 27812, packhamt@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial feasibility (time frame: 3 months). 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 NCT03937232, 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 3 May 2019.