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Effects of Motor Learning After Upper Limb Peripheral Nerve Injury

Primary Purpose

Peripheral Nerve Injury at Forearm Level (Diagnosis)

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
conventional physical therapy
mirror therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury at Forearm Level (Diagnosis) focused on measuring peripheral nerve injury, motor learning, mirror therapy, physical therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing to sign the inform consent
  • Sufficiently communicate in the Chinese language
  • Be able to follow instructions
  • Newly median, ulnar, or radial nerve repair at forearm level in recent 3 weeks

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Central nervous disease
  • A history of nerve entrapment syndrome in recent 1 year
  • Patients with a history of latent neuropathy, such as diabetes, dialysis, and tumor
  • Unable to communicate or comprehend the questionnaires

Sites / Locations

  • Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

conventional physical therapy with mirror therapy

conventional physical therapy

Outcomes

Primary Outcome Measures

change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months
force in grams
change from baseline in two-point discrimination (2PD) at 3 and 6 months
S0-4, higher score indicates better outcome
change from baseline in grip power at 3 and 6 months
grip power in kilograms

Secondary Outcome Measures

change from baseline in upper-extremity functional outcomes at 3 and 6 months
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire ranges from 0-100. Lower score indicates better outcomes.
Minnesota rate of manipulation tests
Manipulation tests in seconds
Purdue Pegboard Test
Manipulation tests in seconds
functional MRI activation
movement and sensory tests to calcuate z-score by software

Full Information

First Posted
August 26, 2019
Last Updated
July 29, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04087577
Brief Title
Effects of Motor Learning After Upper Limb Peripheral Nerve Injury
Official Title
Effects of Motor Learning After Upper Limb Peripheral Nerve Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration. Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life
Detailed Description
The outcome of peripheral nerve injury is related to age, level of injury, the injured nerve, the severity of injury, and the timing and the type of surgery interventions. In addition, high-level peripheral nerve injury would not full recovery, and the prognosis is determined by the nerve regeneration. Conventional physical therapy includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues. However, the nerve regeneration takes several months in high-level median, ulnar or radial nerve injury. Prolonged median or ulnar nerves injury may interfere intrinsic muscular function, and radial nerve injury causes drop hand. Earlier nerve regeneration or motor training is essential for the patients to return to normal life and increase their quality of life. This research aims to explore the effects of mirror therapy for peripheral nerve injury. We will enroll 60 patients who suffer from median, ulnar or radial nerve injury at the level of elbow or proximal forearm. The subjects will be randomized into the mirror-therapy group or the control group. Each group will receive conventional physical therapy (i.e., electrical stimulation, joint range of motion exercise, muscle strengthening training, sensory reeducation training). The mirror-therapy group would be supplemented by motor learning by mirror therapy. The measurements include joint range of motion, pain status, sensibility, grip strength, pinch strength, hand function test and the Disabilities of the Arm, Shoulder and Hand (DASH). Demographic information will be collected and analyzed by the independent t-tests. The outcome variables taken during the three and six months after the interventions would be included. One-way ANOVA are used to compare the difference between measurements. This study may offer an evidence based results to explore the effects of mirror therapy for peripheral nerve regeneration and motor learning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury at Forearm Level (Diagnosis)
Keywords
peripheral nerve injury, motor learning, mirror therapy, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
conventional physical therapy with mirror therapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
conventional physical therapy
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues, sensory relearning
Intervention Type
Other
Intervention Name(s)
mirror therapy
Intervention Description
mirror therapy
Primary Outcome Measure Information:
Title
change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months
Description
force in grams
Time Frame
baseline, 3 months, 6 months
Title
change from baseline in two-point discrimination (2PD) at 3 and 6 months
Description
S0-4, higher score indicates better outcome
Time Frame
baseline, 3 months, 6 months
Title
change from baseline in grip power at 3 and 6 months
Description
grip power in kilograms
Time Frame
baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
change from baseline in upper-extremity functional outcomes at 3 and 6 months
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire ranges from 0-100. Lower score indicates better outcomes.
Time Frame
baseline, 3 months, 6 months
Title
Minnesota rate of manipulation tests
Description
Manipulation tests in seconds
Time Frame
baseline, 3 months and 6 months
Title
Purdue Pegboard Test
Description
Manipulation tests in seconds
Time Frame
baseline, 3 months and 6 months
Title
functional MRI activation
Description
movement and sensory tests to calcuate z-score by software
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing to sign the inform consent Sufficiently communicate in the Chinese language Be able to follow instructions Newly median, ulnar, or radial nerve repair at forearm level in recent 3 weeks Exclusion Criteria: Pregnant or breast-feeding woman Central nervous disease A history of nerve entrapment syndrome in recent 1 year Patients with a history of latent neuropathy, such as diabetes, dialysis, and tumor Unable to communicate or comprehend the questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh-Hsia Chen, Master
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

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Effects of Motor Learning After Upper Limb Peripheral Nerve Injury

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