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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Joy MacDermid, PhD
  • Phone Number: 64636 5196466100
  • Email: jmacderm@uwo.ca

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Experimental: Neuromuscular Stimulation (NMES)
Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
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.
Experimental: Mirror Therapy + NMES
Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 6 weeks post fracture
% of sessions completed
6 weeks post fracture

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Western University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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