Distal Radius FractureNCT05925673
Early NMES and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
A study testing Mirror Therapy, Neuromuscular Stimulation (NMES) and Mirror Therapy + NMES in people with Distal Radius Fracture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Mirror Therapy, Neuromuscular Stimulation (NMES) and Mirror Therapy + NMES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2024to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Roth | McFarlane Hand and Upper Limb Center
London, Ontario, N6A4L6
Joy MacDermid, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Mirror Therapy, Neuromuscular Stimulation (NMES), Mirror Therapy + NMES
- Keywords
- Neuromuscular Stimulation, Mirror Therapy, Early Intervention
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
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.
Neuromuscular Stimulation (NMES)Other
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.
Mirror Therapy + NMESOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London. |
| Mirror Therapy | Experimental | Participants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture. Receives: Other: Mirror Therapy |
| Neuromuscular Stimulation (NMES) | Experimental | Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture. Receives: Other: Neuromuscular Stimulation (NMES) |
| Mirror Therapy + NMES | Experimental | Participants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture. Receives: Other: Mirror Therapy + NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
% of sessions completed
Measured: 6 weeks post fracture
Secondary outcomes (15)
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 150, with a higher score representing more pain and disability.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
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.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
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.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
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.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
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).
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
Range of motion (ROM) - unaffected side
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.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
Range of motion (ROM) - affected side
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.
Measured: 6, 8 to 10, and 12 weeks post fracture
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 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.
Measured: Baseline, 6, 8, 10, and 12 weeks post fracture
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.
Measured: Baseline, 8 to 10, and 12 weeks post fracture
Pinch Strength - unaffected side
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.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
Pinch Strength - affected side
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.
Measured: 8 to 10, and 12 weeks post fracture
Electromyography (EMG)
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.
Measured: 8 to 10 and 12 weeks post fracture
Grip Strength - unaffected side
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.
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
Grip Strength - affected side
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.
Measured: 8 to 10, and 12 weeks post fracture
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).
Measured: Baseline, 6, 8 to 10, and 12 weeks post fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start9 Feb 2024
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Joy MacDermid, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Joy MacDermid, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925673
- Sponsor's protocol ID
- 120275
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neuromuscular Stimulation and Mirror Therapy Interventions During Immobilization of Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT05925673
- Acronym / sponsor ID
- 120275
- Conditions
- Distal Radius Fracture
- Keywords
- Neuromuscular Stimulation, Mirror Therapy, Early Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will follow standard practice protocols at the Roth McFarlane Hand and Upper Limb Centre in London. |
| Mirror Therapy | Experimental | Other: Mirror TherapyParticipants will engage in a home based mirror therapy intervention from 3 to 6 weeks post-fracture. |
| Neuromuscular Stimulation (NMES) | Experimental | Other: Neuromuscular Stimulation (NMES)Participants will engage in a home based neuromuscular stimulation intervention from 3 to 6 weeks post-fracture. |
| Mirror Therapy + NMES | Experimental | Other: Mirror Therapy + NMESParticipants will engage in a home based combined mirror therapy + neuromuscular stimulation intervention from 3 to 6 weeks post-fracture. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror TherapyParticipants 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. | Other | Mirror Therapy |
| 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. | Other | Neuromuscular Stimulation (NMES) |
| Mirror Therapy + NMESParticipants 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. | Other | Mirror Therapy + NMES |
Primary outcome
Adherence
Time frame: 6 weeks post fracture
% of sessions completed
15 secondary outcomes
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 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
Single Assessment Numeric Evaluation (SANE)
Time frame: 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
Numeric Pain Rating Scale (NPRS) at rest
Time frame: 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
Range of motion (ROM) - affected side
Time frame: 6, 8 to 10, and 12 weeks post fracture
Dexterity
Time frame: 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
Pinch Strength - unaffected side
Time frame: Baseline, 6, 8 to 10, and 12 weeks post fracture
Pinch Strength - affected side
Time frame: 8 to 10, and 12 weeks post fracture
Electromyography (EMG)
Time frame: 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 - affected side
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy MacDermid, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy, Neuromuscular Stimulation (NMES) and Mirror Therapy + NMES in people with Distal Radius Fracture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joy MacDermid, PhD (5196466100 ext. 64636, jmacderm@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 6 weeks post fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.