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Completed

NCT Number: NCT04087577

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional physical therapy

Other

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

Other

mirror therapy

Primary outcomes

  1. change from baseline in Semmes-Weinstei monofilaments (SWM) at 3 and 6 months

    Time frame: baseline, 3 months, 6 months

    force in grams

  2. change from baseline in two-point discrimination (2PD) at 3 and 6 months

    Time frame: baseline, 3 months, 6 months

    S0-4, higher score indicates better outcome

  3. change from baseline in grip power at 3 and 6 months

    Time frame: baseline, 3 months, 6 months

    grip power in kilograms

Secondary outcomes

  1. change from baseline in upper-extremity functional outcomes at 3 and 6 months

    Time frame: baseline, 3 months, 6 months

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire ranges from 0-100. Lower score indicates better outcomes.

  2. Minnesota rate of manipulation tests

    Time frame: baseline, 3 months and 6 months

    Manipulation tests in seconds

  3. Purdue Pegboard Test

    Time frame: baseline, 3 months and 6 months

    Manipulation tests in seconds

  4. functional MRI activation

    Time frame: 3 months

    movement and sensory tests to calcuate z-score by software

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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