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Clinical Trials/NCT05925673
NCT05925673
Recruiting
Not Applicable

Early Neuromuscular Stimulation and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture

Lawson Health Research Institute1 site in 1 country72 target enrollmentFebruary 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
Lawson Health Research Institute
Enrollment
72
Locations
1
Primary Endpoint
Adherence
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2024
End Date
August 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joy MacDermid

Professor

Lawson Health Research Institute

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

Outcomes

Primary Outcomes

Adherence

Time Frame: 6 weeks post fracture

% of sessions completed

Secondary Outcomes

  • EuroQol-5D (EQ-5D)(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)
  • Single Assessment Numeric Evaluation (SANE)(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Range of motion (ROM) - affected side(6, 8 to 10, and 12 weeks post fracture)
  • Pinch Strength - unaffected side(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Electromyography (EMG)(8 to 10 and 12 weeks post fracture)
  • Patient-Rated Wrist Evaluation (PRWE)(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Vividness of Movement Imagery Questionnaire-2 (VIMQ-2)(Baseline, 8 to 10, and 12 weeks post fracture)
  • Range of motion (ROM) - unaffected side(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Dexterity(Baseline, 6, 8, 10, and 12 weeks post fracture)
  • Pinch Strength - affected side(8 to 10, and 12 weeks post fracture)
  • Grip Strength - unaffected side(Baseline, 6, 8 to 10, and 12 weeks post fracture)
  • Grip Strength - affected side(8 to 10, and 12 weeks post fracture)
  • Numeric Pain Rating Scale (NPRS) during movement(Baseline, 6, 8 to 10, and 12 weeks post fracture)

Study Sites (1)

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