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Mirrored Movement Compared to Cross-education

Primary Purpose

Hand Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cross-Education
Mirror Visual Feedback
Usual care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Cross-Education

    Mirror Visual Feedback

    Cross-education + Mirror Visual Feedback

    Usual Care

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Trial feasibility
    total number of potential participants vs. enrolled participants from the clinic

    Secondary Outcome Measures

    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
    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.
    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.
    Hand grip strength
    Grip strength as measured by hand dynamometer (in kilos).
    Adverse events
    Number of major adverse events defined as need for secondary surgical intervention

    Full Information

    First Posted
    April 30, 2019
    Last Updated
    May 2, 2019
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03937232
    Brief Title
    Mirrored Movement Compared to Cross-education
    Official Title
    Mirrored Movement Compared to Cross-education for Recovery After Hand or Wrist Injury: a Pilot Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    Cross-education OR Mirror visual feedback OR Cross-education + mirror visual feedback OR usual care
    Masking
    Outcomes Assessor
    Masking Description
    Outcomes assessor blinded to group allocation
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cross-Education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Mirror Visual Feedback
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Cross-education + Mirror Visual Feedback
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cross-Education
    Intervention Description
    Home exercise program + usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mirror Visual Feedback
    Intervention Description
    Home exercise program + usual care
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
    Primary Outcome Measure Information:
    Title
    Trial feasibility
    Description
    total number of potential participants vs. enrolled participants from the clinic
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Composite finger flexion
    Description
    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
    Time Frame
    1, 2, and 3 months
    Title
    Patient-Rated Wrist and Hand Evaluation
    Description
    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.
    Time Frame
    1,2,and 3 months
    Title
    Pain Catastrophizing Scale
    Description
    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.
    Time Frame
    3 months
    Title
    Hand grip strength
    Description
    Grip strength as measured by hand dynamometer (in kilos).
    Time Frame
    3 months
    Title
    Adverse events
    Description
    Number of major adverse events defined as need for secondary surgical intervention
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tara Packham, PhD
    Phone
    9055259140
    Ext
    27812
    Email
    packhamt@mcmaster.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29668382
    Citation
    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.
    Results Reference
    background

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    Mirrored Movement Compared to Cross-education

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