- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768857
Effects of Early Sensory Reeducation Programs Using Mirror Therapy for Patients With Peripheral Nerve Injuries
May 12, 2016 updated by: National Cheng-Kung University Hospital
A Touch-Observation and Task-based Mirror Therapy Protocol (MTPTOT) to Improve Sensorimotor Control and Functional Capability of Hands for Patients With Peripheral Nerve Injury
This study evaluated the effects of an integrated program of touch-observation and task-based mirror therapy on sensorimotor function in nerve injury patients.
Before the return of protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session.
Once the patients had regained the protective sense (Value of Semmes-Weinstein monofilament test < 4.31), the discriminative sensory reeducation program was started for the participants in both groups.
The hypothesis was that using the mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield better results with regard to the returning of sensation, sensorimotor control ability and hand function than using a classical reeducation program alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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 Locations
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Tainan, Taiwan, 704
- National Cheng-Kung University Hospital
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- median or ulnar nerve injury,
- a combination of nerve and tendon or vascular injury,
- injury sites between the level of mid-palm and elbow, and
- the protective sensation of the hand is lacking or impaired.
Exclusion Criteria:
- patients with deficits in cognition or language comprehension, as well as severe limitations in the range of motion of the upper limbs.
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early sensorimotor reeducation intervention
The experimental group received 15 minutes of touch-observation and task-based mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session before the returning of the touch of a Semmes-Weinstein monofilament marked 4.31.
Once the patients had regained the protective sense (SWM < 4.31), the mirror therapy program was replaced with a discriminative sensory reeducation program.
Treatment duration was 12 weeks, at a frequency of three sessions per week.
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Active Comparator: Traditional sensorimotor reeducation intervention
The control group received received 15 minutes traditional sensory reeducation program, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session before the returning of the touch of a Semmes-Weinstein monofilament marked 4.31.
Once the patients had regained the protective sense (SWM < 4.31), the protective sensory reeducation program was replaced with a discriminative sensory reeducation program.
Treatment duration was 12 weeks, at a frequency of three sessions per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks
Time Frame: baseline, 12 weeks and 24 weeks
|
baseline, 12 weeks and 24 weeks
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Change from baseline result of Purdue pegboard test at 12 weeks and 24 weeks
Time Frame: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
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Change from baseline result of Minnesota manual dexterity test at 12 weeks and 24 weeks
Time Frame: baseline, 12 weeks and 24 weeks
|
baseline, 12 weeks and 24 weeks
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Change from baseline result of Pinch-holding-up-activity (PHUA) test at 12 weeks and 24 weeks
Time Frame: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline result of Static two-point discrimination (S2PD) test at 12 weeks and 24 weeks
Time Frame: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
December 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 5, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Estimate)
May 16, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-ER-102-389
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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