Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
Early Neuromuscular Stimulation and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
February 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedMarch 25, 2024
March 1, 2024
4 months
June 20, 2023
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence
% of sessions completed
6 weeks post fracture
Secondary Outcomes (15)
Patient-Rated Wrist Evaluation (PRWE)
Baseline, 6, 8 to 10, and 12 weeks post fracture
EuroQol-5D (EQ-5D)
Baseline, 6, 8 to 10, and 12 weeks post fracture
Single Assessment Numeric Evaluation (SANE)
Baseline, 6, 8 to 10, and 12 weeks post fracture
Global Rating of Change (GRC)
Baseline, 6, 8 to 10, and 12 weeks post fracture
Numeric Pain Rating Scale (NPRS) at rest
Baseline, 6, 8 to 10, and 12 weeks post fracture
- +10 more secondary outcomes
Study Arms (4)
Standard of Care
NO INTERVENTIONParticipants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London.
Mirror Therapy
EXPERIMENTALParticipants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture.
Neuromuscular Stimulation (NMES)
EXPERIMENTALParticipants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
Mirror Therapy + NMES
EXPERIMENTALParticipants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roth | McFarlane Hand and Upper Limb Center
London, Ontario, N6A4L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joy MacDermid, PhD
Western University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2023
First Posted
June 29, 2023
Study Start
February 9, 2024
Primary Completion
June 1, 2024
Study Completion
August 1, 2024
Last Updated
March 25, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share