Effects of Motor Learning After Upper Limb Peripheral Nerve Injury

NCT04087577 | Completed

• 1 other identifier: 201900433A3
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Peripheral Nerve Injury at Forearm Level (Diagnosis)

Keywords

peripheral nerve injury; motor learning; mirror therapy; physical therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

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

  baseline, 3 months, 6 months

• Minnesota rate of manipulation tests

  baseline, 3 months and 6 months

• Purdue Pegboard Test

  baseline, 3 months and 6 months

• functional MRI activation

  3 months

Study Arms (2)

experimental group

EXPERIMENTAL

conventional physical therapy with mirror therapy

Other: conventional physical therapy; Other: mirror therapy

control group

ACTIVE COMPARATOR

conventional physical therapy

Other: conventional physical therapy

Interventions

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

control group; experimental group

mirror therapy OTHER

mirror therapy

experimental group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

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

Taoyuan District, 333, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Disease; Peripheral Nerve Injuries

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Yueh-Hsia Chen, Master

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 12, 2019
• Study Start: December 19, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 2, 2021

Record last verified: 2020-07

Locations

TW (2)