Effects of Early Sensory Reeducation Programs Using Mirror Therapy for Patients With Peripheral Nerve Injuries

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Sensorimotor reeducation programs

About this trial

This is an interventional treatment trial for Sensation Disorders

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Cheng-Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early sensorimotor reeducation intervention

Traditional sensorimotor reeducation intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks

Change from baseline result of Purdue pegboard test at 12 weeks and 24 weeks

Change from baseline result of Minnesota manual dexterity test at 12 weeks and 24 weeks

Change from baseline result of Pinch-holding-up-activity (PHUA) test at 12 weeks and 24 weeks

Secondary Outcome Measures

Change from baseline result of Static two-point discrimination (S2PD) test at 12 weeks and 24 weeks

Full Information

NCT ID

NCT02768857

First Posted

May 5, 2016

Last Updated

May 12, 2016

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02768857

Brief Title

Effects of Early Sensory Reeducation Programs Using Mirror Therapy for Patients With Peripheral Nerve Injuries

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sensation Disorders, Motor Deficit, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early sensorimotor reeducation intervention

Arm Type

Experimental

Arm Description

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.

Arm Title

Traditional sensorimotor reeducation intervention

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sensorimotor reeducation programs

Primary Outcome Measure Information:

Title

Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks

Time Frame