NCT03937232

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Status
unknown

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

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

April 30, 2019

Last Update Submit

May 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Trial feasibility

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

    3 months

Secondary Outcomes (5)

  • Composite finger flexion

    1, 2, and 3 months

  • Patient-Rated Wrist and Hand Evaluation

    1,2,and 3 months

  • Pain Catastrophizing Scale

    3 months

  • Hand grip strength

    3 months

  • Adverse events

    3 months

Study Arms (4)

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.

Behavioral: Cross-EducationOther: 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.

Behavioral: Mirror Visual FeedbackOther: 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.

Behavioral: Mirror Visual FeedbackOther: 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.

Other: Usual care

Interventions

Cross-EducationBEHAVIORAL

Home exercise program + usual care

Cross-Education

Home exercise program + usual care

Cross-education + Mirror Visual FeedbackMirror Visual Feedback

Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting

Cross-EducationCross-education + Mirror Visual FeedbackMirror Visual FeedbackUsual Care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29668382BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Tara Packham, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor blinded to group allocation
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Cross-education OR Mirror visual feedback OR Cross-education + mirror visual feedback OR usual care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 3, 2019

Study Start

September 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share