Effects of Motor Learning After Upper Limb Peripheral Nerve Injury

Peripheral Nerve Injury at Forearm Level (Diagnosis) Clinical Trial

Official title:

Effects of Motor Learning After Upper Limb Peripheral Nerve Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087577
• Other study ID #: 201900433A3
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: July 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury at Forearm Level (Diagnosis)
• Wounds and Injuries

Intervention

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
• mirror therapy
mirror therapy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Taiwan	Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months	force in grams	baseline, 3 months, 6 months
Primary	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
Primary	change from baseline in grip power at 3 and 6 months	grip power in kilograms	baseline, 3 months, 6 months
Secondary	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
Secondary	Minnesota rate of manipulation tests	Manipulation tests in seconds	baseline, 3 months and 6 months
Secondary	Purdue Pegboard Test	Manipulation tests in seconds	baseline, 3 months and 6 months
Secondary	functional MRI activation	movement and sensory tests to calcuate z-score by software	3 months