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

Status

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

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.

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 (Actual)

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.
12

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 Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung University Hospital

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

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

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.
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.
Behavioral: Sensorimotor reeducation programs
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.
Behavioral: Sensorimotor reeducation programs

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
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
Change from baseline result of Purdue pegboard test at 12 weeks and 24 weeks
Time Frame: baseline, 12 weeks and 24 weeks
baseline, 12 weeks and 24 weeks
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
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
baseline, 12 weeks and 24 weeks

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
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
baseline, 12 weeks and 24 weeks

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.
National Cheng-Kung University Hospital

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

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.
December 1, 2014

Primary Completion (Actual)

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.
October 1, 2015

Study Completion (Actual)

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.
October 1, 2015

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).
May 5, 2016

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.
May 10, 2016

First Posted (Estimate)

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.
May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
May 16, 2016

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.
May 12, 2016

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.
May 1, 2016

More Information

Terms related to this study

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.
  • 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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