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Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture

Primary Purpose

Distal Radius Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mirror Therapy
Neuromuscular Stimulation (NMES)
Mirror Therapy + NMES
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Neuromuscular Stimulation, Mirror Therapy, Early Intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roth | McFarlane Hand and Upper Limb Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Standard of Care

Mirror Therapy

Neuromuscular Stimulation (NMES)

Mirror Therapy + NMES

Arm Description

Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London.

Participants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture.

Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.

Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.

Outcomes

Primary Outcome Measures

Adherence
% of sessions completed

Secondary Outcome Measures

Patient-Rated Wrist Evaluation (PRWE)
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 100, with a higher score representing more pain and disability.
EuroQol-5D (EQ-5D)
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.
Single Assessment Numeric Evaluation (SANE)
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.
Global Rating of Change (GRC)
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.
Numeric Pain Rating Scale (NPRS) at rest
Participants will rate their pain level at rest on a scale from 0 (no pain) to 10 (unbearable pain).
Range of motion (ROM)
Wrist flexion, extension, ulnar deviation, radial deviation, elbow supination, elbow pronation, and thumb extension 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 assessed for both the affected and unaffected side and recorded as degrees of motion.Higher scores will represent greater grip strength.
Dexterity
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 conditions. 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, and collars using both hands for 30 sec. For each condition they will be instructed to complete as many as possible in the 30 seconds. Higher scores indicate better dexterity.
Vividness of Movement Imagery Questionnaire-2 (VIMQ-2)
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.
Pinch Strength
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. Pinch grip will be assessed for both the affected and unaffected side. Higher scores will represent greater pinch strength.
Electromyography (EMG)
Electromyography of the wrist flexors and extensors will be measured using the DELSYS Trigno Wireless Biofeedback System. Participants will complete three maximum voluntary contractions (MVC) for 5 seconds with with each hand in wrist extension, flexion, ulnar deviation and radial deviation. 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.
Grip Strength
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. Grip strength will be measured on the affected and unaffected side
Numeric Pain Rating Scale (NPRS) during movement
Participants will rate their pain level during movement on a scale from 0 (no pain) to 10 (unbearable pain).

Full Information

First Posted
June 20, 2023
Last Updated
June 27, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Western University, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05925673
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Western University, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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. Peripheral 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 cast removal (6 weeks), 8, 10, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Neuromuscular Stimulation, Mirror Therapy, Early Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London.
Arm Title
Mirror Therapy
Arm Type
Experimental
Arm Description
Participants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture.
Arm Title
Neuromuscular Stimulation (NMES)
Arm Type
Experimental
Arm Description
Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
Arm Title
Mirror Therapy + NMES
Arm Type
Experimental
Arm Description
Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Stimulation (NMES)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy + NMES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence
Description
% of sessions completed
Time Frame
12 weeks post fracture
Secondary Outcome Measure Information:
Title
Patient-Rated Wrist Evaluation (PRWE)
Description
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 100, with a higher score representing more pain and disability.
Time Frame
Baseline, 6, 8, 10, and 12 weeks post fracture
Title
EuroQol-5D (EQ-5D)
Description
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.
Time Frame
Baseline, 6, 8, 10, and 12 weeks post fracture
Title
Single Assessment Numeric Evaluation (SANE)
Description
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.
Time Frame
Baseline, 6, 8, 10, and 12 weeks post fracture
Title
Global Rating of Change (GRC)
Description
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.
Time Frame
Baseline, 6, 8, 10, and 12 weeks post fracture
Title
Numeric Pain Rating Scale (NPRS) at rest
Description
Participants will rate their pain level at rest on a scale from 0 (no pain) to 10 (unbearable pain).
Time Frame
Baseline, 6, 8, 10, and 12 weeks post fracture
Title
Range of motion (ROM)
Description
Wrist flexion, extension, ulnar deviation, radial deviation, elbow supination, elbow pronation, and thumb extension 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 assessed for both the affected and unaffected side and recorded as degrees of motion.Higher scores will represent greater grip strength.
Time Frame
6, 8, 10, and 12 weeks post fracture
Title
Dexterity
Description
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 conditions. 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, and collars using both hands for 30 sec. For each condition they will be instructed to complete as many as possible in the 30 seconds. Higher scores indicate better dexterity.
Time Frame
6, 8, 10, and 12 weeks post fracture
Title
Vividness of Movement Imagery Questionnaire-2 (VIMQ-2)
Description
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.
Time Frame
Baseline, 8, 10, and 12 weeks post fracture
Title
Pinch Strength
Description
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. Pinch grip will be assessed for both the affected and unaffected side. Higher scores will represent greater pinch strength.
Time Frame
8, 10, and 12 weeks post fracture
Title
Electromyography (EMG)
Description
Electromyography of the wrist flexors and extensors will be measured using the DELSYS Trigno Wireless Biofeedback System. Participants will complete three maximum voluntary contractions (MVC) for 5 seconds with with each hand in wrist extension, flexion, ulnar deviation and radial deviation. 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.
Time Frame
8 and 12 weeks post fracture
Title
Grip Strength
Description
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. Grip strength will be measured on the affected and unaffected side
Time Frame
8, 10, and 12 weeks post fracture
Title
Numeric Pain Rating Scale (NPRS) during movement
Description
Participants will rate their pain level during movement on a scale from 0 (no pain) to 10 (unbearable pain).
Time Frame
Baseline, 6, 8, 10, and 12 weeks post fracture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joy MacDermid, PhD
Phone
5196466100
Ext
64636
Email
jmacderm@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Munro
Phone
5196466100
Ext
64640
Email
katrina.munro@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roth | McFarlane Hand and Upper Limb Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture

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