Exercise Training for Brachial Plexus Injury Following Nerve Transfer

NCT ID: NCT05859178

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-05-31

Brief Summary

Although peripheral nerve is capable of regrowth following injury, at only 1 mm/day, the slow rate represents a major barrier. Apart from rapid deterioration of the environment supportive of growth, denervated muscles become atrophic and bones osteoporotic. To successfully restore function, in addition to speeding up the nerve regeneration rate, treatments that can also restore muscle and bone mass are essential. Recently, in animal studies, the investigators showed that in addition to accelerating the speed of nerve regeneration, exercise training can also be used to restore muscle bulk and bone density. While promising, given the inter-species differences, the clinical utilities of this treatment need to be directly tested in humans. This will be done using a randomized controlled study design on patients with brachial plexus injury.

Detailed Description

Peripheral nerve injury is common, affecting 3% of patients with limb trauma seen in the emergency department. Of those, young males who are active in the work force are most frequently inflicted. The functional loss does not only carry a huge personal burden but is also associated with substantial healthcare and socioeconomic costs. Indeed, based on data from the National Inpatient Sample in the US, estimated direct healthcare costs for patients who sustained upper limb nerve injury is over $1.2B per year. Although in previous studies the investigators found that conditioning electrical stimulation, a form of activity dependent therapy, enhances nerve regeneration following injury, it did not improve bone density. Therefore, alternative treatments capable of promoting bone formation, restoring muscle bulk and increasing nerve regeneration are needed.

Based on recent discoveries in animal studies, the goal of this randomized controlled clinical trial is to test the hypothesis that exercise training can accelerate nerve regeneration and significantly increase muscle bulk and bone density compared to surgery alone in patients with brachial plexus injury.

To test this hypothesis, patients with brachial plexus injury involving the musculocutaneous nerve will be randomized to the exercise or control group following nerve transfer surgery. This will be done using a redundant branch of the ulnar nerve to reinnervate the biceps muscle. To evaluate the treatment efficacy, compound muscle action potential of the biceps muscle will be used as the primary outcome measure to quantify reinnervation. The following anatomic and functional measures will be used as secondary outcome measures: i) muscle bulk of the biceps using MRI; ii) bone density of the humerus using dual-energy x-ray absorptiometry (DEXA) imaging; iii) quantitative force measurement for elbow flexion; iv) the Disability of Arm, Shoulder and Hand (DASH) instrument to assess disability, and v) the Canadian Occupational Performance Measure for limitations in participation.

Conditions

Brachial Plexus Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise group

Each participant in the exercise group will undergo hand grip exercise for 30 minutes a day, 5 days a week for a total of 12 weeks. To activate the ulnar nerve innervated muscles, the exercise will be done using an electronic hand grip device with adjustable resistance individualized to the strength of each participant.

Group Type: EXPERIMENTAL

Exercise group

Intervention Type: OTHER

Along with nerve transfer surgery, individuals in the exercise group will undergo handgrip exercise for 30 minutes a day, 5 days a week for a total of 12 weeks.

Control group

Participants will carry out a stretch exercise routine that is not known to have any effect on nerve regeneration.

Group Type: EXPERIMENTAL

Exercise group

Intervention Type: OTHER

Along with nerve transfer surgery, individuals in the exercise group will undergo handgrip exercise for 30 minutes a day, 5 days a week for a total of 12 weeks.

Interventions

Exercise group

Along with nerve transfer surgery, individuals in the exercise group will undergo handgrip exercise for 30 minutes a day, 5 days a week for a total of 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adults age 18-60
• electrodiagnostically confirmed brachial plexus injury affecting the musculocutaneous nerve
• able to consent for participation.

Exclusion Criteria

• individuals with additional neurological or musculoskeletal conditions that would affect elbow and hand function

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Alexandra Hospital

OTHER

Sponsor Role: collaborator

Glenrose Foundation

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Central Contacts

Ming Chan

Role: CONTACT

ming.chan@ualberta.ca

780-492-9343

Facility Contacts

Ming Chan

Role: primary

ming.chan@ualberta.ca

780-492-9343

Other Identifiers

Pro00128785

Identifier Type: -

Identifier Source: org_study_id