Exercise Training for Brachial Plexus Injury Following Nerve Transfer

Brachial Plexus Injury Clinical Trial

Official title:

Exercise Training to Improve Nerve Regeneration and Function in Patients With Brachial Plexus Injury Following Nerve Transfer - a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05859178
• Other study ID #: Pro00128785
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: Ming Chan
• Phone: 780-492-9343
• Email: ming.chan[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Glenrose Foundation, Royal Alexandra Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor nerve conduction study	compound muscle action potential of the biceps muscle. Range: 0-7 mV. Higher scores signify better nerve regeneration	Baseline, 3, 6 and 9 months post surgery
Secondary	magnetic resonance imaging (MRI)	muscle bulk of the biceps. Measure in cubic cm. Higher score signifies better nerve regeneration.	Baseline, 3, 6 and 9 months post surgery
Secondary	dual energy x-rays absorptiometry (DEXA)	bone density - humerus (g/sq. m). Higher scores denote better outcome	Baseline, 3, 6 and 9 months post surgery
Secondary	quantitative force measurement for elbow flexion using dynamometer DASH Questionnaire	to assess impairment (N). Higher scores denote better outcome	Baseline, 3, 6 and 9 months post surgery
Secondary	Canadian Occupational Performance Measure (COPM)	to assess handicap and participation (Range 1-5). Higher scores denote better outcome	Baseline, 3, 6 and 9 months post surgery