Clinical trial NCT04087577: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Injury at Forearm Level (Diagnosis)
Keywords: peripheral nerve injury
motor learning
mirror therapy
physical therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months
timeFrame: baseline, 3 months, 6 months
measure: change from baseline in two-point discrimination (2PD) at 3 and 6 months
timeFrame: baseline, 3 months, 6 months
measure: change from baseline in grip power at 3 and 6 months
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: change from baseline in upper-extremity functional outcomes at 3 and 6 months
timeFrame: baseline, 3 months, 6 months
measure: Minnesota rate of manipulation tests
timeFrame: baseline, 3 months and 6 months
measure: Purdue Pegboard Test
timeFrame: baseline, 3 months and 6 months
measure: functional MRI activation
timeFrame: 3 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yueh-Hsia Chen, Master
role: PRINCIPAL_INVESTIGATOR
References: