NCT02768857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

May 5, 2016

Last Update Submit

May 12, 2016

Conditions

Sensation DisordersMotor DeficitRehabilitation

Outcome Measures

Primary Outcomes (4)

  • Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 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

    baseline, 12 weeks and 24 weeks

  • Change from baseline result of Minnesota manual dexterity test at 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

    baseline, 12 weeks and 24 weeks

Secondary Outcomes (1)

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

    baseline, 12 weeks and 24 weeks

Study Arms (2)

Early sensorimotor reeducation intervention

EXPERIMENTAL

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

Traditional sensorimotor reeducation intervention

ACTIVE COMPARATOR

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

Interventions

Sensorimotor reeducation programsBEHAVIORAL
Early sensorimotor reeducation interventionTraditional sensorimotor reeducation intervention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients with deficits in cognition or language comprehension, as well as severe limitations in the range of motion of the upper limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

MeSH Terms

Conditions

Sensation DisordersNeurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 11, 2016

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations

TW(1)