Effects of Motor Learning After Upper Limb Peripheral Nerve Injury

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

Study Overview

• Status: Completed
• Conditions: Peripheral Nerve Injury at Forearm Level (Diagnosis)
• Intervention / Treatment: Other: conventional physical therapy; Other: mirror therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital
  • Taoyuan, Taiwan, 333
    • Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group; conventional physical therapy with mirror therapy	Other: 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, sensory relearning; Other: mirror therapy; mirror therapy
ACTIVE_COMPARATOR: control group; conventional physical therapy	Other: 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, sensory relearning

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 3 months, 6 months
Minnesota rate of manipulation tests	Manipulation tests in seconds	baseline, 3 months and 6 months
Purdue Pegboard Test	Manipulation tests in seconds	baseline, 3 months and 6 months
functional MRI activation	movement and sensory tests to calcuate z-score by software	3 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 19, 2019
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: physical therapy; motor learning; peripheral nerve injury; mirror therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nerve Injuries
• Other Study ID Numbers: 201900433A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No