Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture

NCT ID: NCT05925673

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2024-08-31

Brief Summary

Current practice for distal radius fractures is to begin rehabilitation after immobilization to remediate the resulting impairments. Neuromuscular electrical stimulation and mirror therapy are strategies that integrate neurological and musculoskeletal activation, that may be beneficial for mitigating the resulting impairments if applied during immobilization. The study aim is to determine whether neuromuscular stimulation and mirror therapy interventions can be implemented during immobilization for distal radius fractures to minimize the resulting impairments when compared to standard rehabilitation.

Detailed Description

Distal radius fractures are one of the most common orthopedic injuries require 6 to 8 weeks of immobilization for bone healing making it an ideal model to evaluate the negative consequences of immobilization. Consequences of immobilization include motor dysfunction (e.g. muscular atrophy), loss of the representation of motor and sensory function, and loss of fine motor skills. Current practice is to begin rehabilitation after immobilization to remediate these impairments. Neuromuscular electrical stimulation and mirror therapy are strategies that integrate neurological and musculoskeletal functioning, that can be used during immobilization to mitigate negative consequences. To date, these strategies have primarily been implemented in stroke rehabilitation, but minimal research has been done to assess their effectiveness with musculoskeletal populations. The study aim is to determine whether neuromuscular stimulation and mirror therapy interventions can be implemented during immobilization for distal radius fractures to minimize impairments when compared to standard rehabilitation. Four groups will be compared: group 1 will engage in standard care, group 2 will engage in a mirror therapy intervention during immobilization, group 3 will engage in a neuromuscular stimulation intervention during immobilization, and group 4 will engage in a combined mirror therapy + neuromuscular stimulation intervention during immobilization. Patient reported and objective outcome measures will be assessed at baseline (before starting intervention; 3 weeks), after cast removal and completion of the intervention (6 weeks), 8 (to 10) weeks, and 12 weeks post fracture. Ideally these interventions will improve outcomes and facilitate rehabilitation after distal radius fracture which could allow patients to return to their daily activities and work more readily after fracture.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard of Care

Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mirror Therapy

Participants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture.

Group Type: EXPERIMENTAL

Mirror Therapy

Intervention Type: OTHER

Participants will perform exercises with their unaffected arm in front of a mirror with the affected arm hiding behind the mirror. They will watch the reflection of the unaffected arm as they perform the exercises to provide visual feedback that the affected arm is performing the exercises. They will repeat this procedure for 10 minutes, 3 times a day, 5 days a week for 3 weeks.

Neuromuscular Stimulation (NMES)

Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.

Group Type: EXPERIMENTAL

Neuromuscular Stimulation (NMES)

Intervention Type: OTHER

Participants will use a portable NMES machine to stimulate the wrist extensors and flexors of the affected arm at a low intensity with the arm relaxed. They will repeat this procedure for 10 minutes, 3 times a day, 5 days a week for 3 weeks.

Mirror Therapy + NMES

Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.

Group Type: EXPERIMENTAL

Mirror Therapy + NMES

Intervention Type: OTHER

Participants will perform exercises with their unaffected arm in front of a mirror with the affected arm hiding behind the mirror. They will watch the reflection of the unaffected arm as they perform the exercises to provide visual feedback that the affected arm is performing the exercises. During the exercises they will have a portable NMES machine set up to stimulate the wrist extensors and flexors of the affected arm at a low intensity with the arm relaxed. They will repeat this procedure for 10 minutes, 3 times a day, 5 days a week for 3 weeks.

Interventions

Mirror Therapy

Participants will perform exercises with their unaffected arm in front of a mirror with the affected arm hiding behind the mirror. They will watch the reflection of the unaffected arm as they perform the exercises to provide visual feedback that the affected arm is performing the exercises. They will repeat this procedure for 10 minutes, 3 times a day, 5 days a week for 3 weeks.

Intervention Type: OTHER

Neuromuscular Stimulation (NMES)

Participants will use a portable NMES machine to stimulate the wrist extensors and flexors of the affected arm at a low intensity with the arm relaxed. They will repeat this procedure for 10 minutes, 3 times a day, 5 days a week for 3 weeks.

Intervention Type: OTHER

Mirror Therapy + NMES

Participants will perform exercises with their unaffected arm in front of a mirror with the affected arm hiding behind the mirror. They will watch the reflection of the unaffected arm as they perform the exercises to provide visual feedback that the affected arm is performing the exercises. During the exercises they will have a portable NMES machine set up to stimulate the wrist extensors and flexors of the affected arm at a low intensity with the arm relaxed. They will repeat this procedure for 10 minutes, 3 times a day, 5 days a week for 3 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Sustained a distal radius fracture in the last 3 weeks being managed conservatively in a cast
• Able to understand instructions in English
• Able to give informed consent (no known cognitive impairment that would limit this)

Exclusion Criteria

• Cognitive disorders that would preclude the participant from following instructions and engaging in the home interventions
• Visual impairments that limit ability to engage in NMES and mirror therapy interventions
• Superficial metal implants in the injured arm
• Cancer (active)
• Severe peripheral vascular disease
• Thrombophlebitis in injured arm

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Joy MacDermid

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joy MacDermid, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Roth | McFarlane Hand and Upper Limb Center

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Joy MacDermid, PhD

Role: CONTACT

jmacderm@uwo.ca

5196466100 ext. 64636

Katrina Munro

Role: CONTACT

katrina.munro@sjhc.london.on.ca

5196466100 ext. 64640

Facility Contacts

Joy MacDermid, PhD

Role: primary

Other Identifiers

120275

Identifier Type: -

Identifier Source: org_study_id