- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925673
Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
March 21, 2024 updated by: Joy MacDermid, Lawson Health Research Institute
Early Neuromuscular Stimulation and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katrina Munro
- Phone Number: 64640 5196466100
- Email: katrina.munro@sjhc.london.on.ca
Study Contact Backup
- Name: Joy MacDermid, PhD
- Phone Number: 64636 5196466100
- Email: jmacderm@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A4L6
- Recruiting
- Roth | McFarlane Hand and Upper Limb Center
-
Contact:
- Joy MacDermid, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London.
|
|
Experimental: Mirror Therapy
Participants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture.
|
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.
|
Experimental: Neuromuscular Stimulation (NMES)
Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
|
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.
|
Experimental: Mirror Therapy + NMES
Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: 6 weeks post fracture
|
% of sessions completed
|
6 weeks post fracture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Rated Wrist Evaluation (PRWE)
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Participants will report their pain for 5 items, their function for 10 items on a scale from 0 (Never) to 10 (Always).
The overall score (sum of pain + function sub scales) is out of 150, with a higher score representing more pain and disability.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
EuroQol-5D (EQ-5D)
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Participant rates their health status from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
The higher the score, the better the health status.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Single Assessment Numeric Evaluation (SANE)
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
On a scale from 0 to 100. with 100 being normal, participants rate the function of their wrist on that day.
A higher score represents better function.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Global Rating of Change (GRC)
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Participants will rate the overall condition of their elbow/wrist from when they started treatment until the point of measurement on a scale of -5 (very much) to 5 (completely recovered).
The higher the score the greater the improvement.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Numeric Pain Rating Scale (NPRS) at rest
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Participants will rate their pain level at rest on a scale from 0 (no pain) to 10 (unbearable pain).
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Range of motion (ROM) - unaffected side
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Wrist flexion, extension, ulnar deviation, radial deviation, elbow supination, elbow pronation, and thumb extension (radial abduction of the thumb) will be measured using a goniometer with the participant in a seated position and their arm by their side.
Wrist movements will be measured with the elbow at a 90 degree angle.
ROM will be recorded as degrees of motion.
Higher scores will represent greater ROM.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Range of motion (ROM) - affected side
Time Frame: 6, 8 to 10, and 12 weeks post fracture
|
Wrist flexion, extension, ulnar deviation, radial deviation, elbow supination, elbow pronation, and thumb extension (radial abduction of the thumb) will be measured using a goniometer with the participant in a seated position and their arm by their side.
Wrist movements will be measured with the elbow at a 90 degree angle.
ROM will be recorded as degrees of motion.
Higher scores will represent greater ROM.
|
6, 8 to 10, and 12 weeks post fracture
|
Dexterity
Time Frame: Baseline, 6, 8, 10, and 12 weeks post fracture
|
Dexterity will be measured using a Purdue Pegboard.
Participants will be seated at a table with the Purdue Pegboard in front of them.
They will complete four subtests.
First they will place as many pins as they can in the holes with the right hand in 30 sec.
This will be repeated on the left.
For the third condition they will have 30 sec to place as many pins in the holes using both hands simultaneously.
The final condition they will assemble the pins, washers, collars, and washers leading with one hand for 60 sec, then repeating with the other hand leading for 60 sec.
For each condition they will be instructed to complete as many as possible in the allotted time.
Higher scores indicate better dexterity.
During baseline assessment only the single hand condition for the unaffected side will be assessed.
|
Baseline, 6, 8, 10, and 12 weeks post fracture
|
Vividness of Movement Imagery Questionnaire-2 (VIMQ-2)
Time Frame: Baseline, 8 to 10, and 12 weeks post fracture
|
A 36-item questionnaire with twelve actions that are imagined kinaesthetically and from an internal and external visual perspective.
The vividness of each imagination is rated on a scale from 1 (Perfectly clear and as vivid (as normal vision or feel of movement)) to 5 (No image at all, you only "know" that you are thinking of the skill).
Scores range from 36 to 180, with lower scores indicative of vivid imagery.
|
Baseline, 8 to 10, and 12 weeks post fracture
|
Pinch Strength - unaffected side
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Pinch grip will be measured in pounds using a Jamar Hydraulic Pinch Gauge with the participant in a seated position with their elbow resting on a table.
Higher scores will represent a stronger pinch grip.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Pinch Strength - affected side
Time Frame: 8 to 10, and 12 weeks post fracture
|
Pinch grip will be measured in pounds using a Jamar Hydraulic Pinch Gauge with the participant in a seated position with their elbow resting on a table.
Higher scores will represent stronger pinch grip.
|
8 to 10, and 12 weeks post fracture
|
Electromyography (EMG)
Time Frame: 8 to 10 and 12 weeks post fracture
|
Electromyography of the wrist flexors and extensors will be measured using the DELSYS Trigno Wireless Biofeedback System.
EMG will be assessed during the three maximum voluntary contractions (MVC) for 5 sec in wrist flexion, radial deviation, wrist extension, and ulnar deviation on both sides.
Participants will be seated with their arm by their side and elbow at a 90 degree angle.
For wrist flexion and radial deviation, participants will have their hands under the table to push up into it for the MVC.
With wrist flexion the palm is facing the ceiling and for radial deviation their hand will make a fist with their thumb oriented towards the ceiling.
For wrist extension and ulnar deviation, participants will have their hand set on top of the table to push down into it for the MVC.
For wrist extension, their fingers will be extended and palm facing the ceiling.
For ulnar deviation, participants will make a fist and their thumb will be oriented towards the ceiling.
|
8 to 10 and 12 weeks post fracture
|
Grip Strength - unaffected side
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Grip strength will be measured with the patient in a seated position with their elbow resting on a table.
A Jamar Hydraulic Hand Dynamometer will be used as a means to measure grip strength in pounds.
Higher scores will represent greater grip strength.
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Grip Strength - affected side
Time Frame: 8 to 10, and 12 weeks post fracture
|
Grip strength will be measured with the patient in a seated position with their elbow resting on a table.
A Jamar Hydraulic Hand Dynamometer will be used as a means to measure grip strength in pounds.
Higher scores will represent greater grip strength.
|
8 to 10, and 12 weeks post fracture
|
Numeric Pain Rating Scale (NPRS) during movement
Time Frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Participants will rate their pain level during movement on a scale from 0 (no pain) to 10 (unbearable pain).
|
Baseline, 6, 8 to 10, and 12 weeks post fracture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joy MacDermid, PhD, Western University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
June 20, 2023
First Submitted That Met QC Criteria
June 27, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Distal Radius Fracture
-
University of AarhusCompletedDistal Radius Fracture | Radius Fracture Distal | Radius Distal FractureDenmark
-
University of DuhokCompletedChildren, Only | Fracture Distal RadiusIraq
-
Carlos A Acosta-OlivoCompleted
-
Hand Surgery Associates LLCOrthopaedic Specialty Group PC, Fairfield; Touro University NevadaRecruitingDistal Radius FracturesUnited States
-
Radboud University Medical CenterNot yet recruiting
-
Zimmer BiometActive, not recruitingDistal Radius Fracture | Osteotomy | Distal Ulna FractureUnited Kingdom
-
University of North Carolina, Chapel HillNot yet recruitingDistal Radius FracturesUnited States
-
Istanbul UniversityCompletedDistal Radius FracturesTurkey
-
Novadip BiosciencesPrimeVigilance; Data Investigation Company Europe (DICE)Active, not recruitingDistal Radius FracturesLuxembourg
-
Spaarne GasthuisMaasstad Hospital; Amsterdam UMCNot yet recruitingFractures, Bone | Distal Radius FracturesNetherlands
Clinical Trials on Mirror Therapy
-
The Hong Kong Polytechnic UniversityNational University, Singapore; University of CanterburyNot yet recruiting
-
Olga Del Pozo BlancoHospital Universitario La Fe; University Rovira i VirgiliCompletedCarpal Tunnel SyndromeSpain
-
Istanbul Medipol University HospitalCompleted
-
The Hong Kong Polytechnic UniversityTung Wah Hospital; Guangdong 999 Brain HospitalCompletedThe Effects of Mirror Therapy on Patients With Unilateral Neglect After Stroke
-
CEU San Pablo UniversityCompleted
-
Kaohsiung Medical University Chung-Ho Memorial...Recruiting
-
Universitat Internacional de CatalunyaEnrolling by invitationHemiplegic Cerebral Palsy | Mirror Movement TherapySpain
-
Seoul National University HospitalSeoul National UniversityCompleted
-
Chang Gung Memorial HospitalRecruiting
-
National Taiwan University HospitalCompleted