Clinical trial NCT05925673: Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
Official title: Early Neuromuscular Stimulation and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Neuromuscular Stimulation
Mirror Therapy
Early Intervention
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Western University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-06-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence
timeFrame: 6 weeks post fracture
Secondary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: EuroQol-5D (EQ-5D)
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Global Rating of Change (GRC)
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Numeric Pain Rating Scale (NPRS) at rest
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Range of motion (ROM) - unaffected side
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Range of motion (ROM) - affected side
timeFrame: 6, 8 to 10, and 12 weeks post fracture
measure: Dexterity
timeFrame: Baseline, 6, 8, 10, and 12 weeks post fracture
measure: Vividness of Movement Imagery Questionnaire-2 (VIMQ-2)
timeFrame: Baseline, 8 to 10, and 12 weeks post fracture
measure: Pinch Strength - unaffected side
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Pinch Strength - affected side
timeFrame: 8 to 10, and 12 weeks post fracture
measure: Electromyography (EMG)
timeFrame: 8 to 10 and 12 weeks post fracture
measure: Grip Strength - unaffected side
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
measure: Grip Strength - affected side
timeFrame: 8 to 10, and 12 weeks post fracture
measure: Numeric Pain Rating Scale (NPRS) during movement
timeFrame: Baseline, 6, 8 to 10, and 12 weeks post fracture
Other outcomes:
Locations:
city: London
country: Canada
facility: Roth | McFarlane Hand and Upper Limb Center
state: Ontario
Study officials:
affiliation: Western University
name: Joy MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References: