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Exercise Training for Brachial Plexus Injury Following Nerve Transfer

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05859178
Enrollment
0
Registered
2023-05-15
Start date
2026-03-01
Completion date
2026-05-04
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Injury

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.

Interventions

OTHERExercise 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.

Sponsors

University of Alberta
Lead SponsorOTHER
Royal Alexandra Hospital
CollaboratorOTHER
Glenrose Foundation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The assessor will not be involved in treatment delivery. Participants in the control group will carry out sham exercise.

Intervention model description

Participants assigned to the exercise group will perform strengthening exercise. Those assigned to the control group will carry out stretch exercise that is not known to have any effect on nerve regeneration.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Motor nerve conduction studyBaseline, 3, 6 and 9 months post surgerycompound muscle action potential of the biceps muscle. Range: 0-7 mV. Higher scores signify better nerve regeneration

Secondary

MeasureTime frameDescription
magnetic resonance imaging (MRI)Baseline, 3, 6 and 9 months post surgerymuscle bulk of the biceps. Measure in cubic cm. Higher score signifies better nerve regeneration.
dual energy x-rays absorptiometry (DEXA)Baseline, 3, 6 and 9 months post surgerybone density - humerus (g/sq. m). Higher scores denote better outcome
quantitative force measurement for elbow flexion using dynamometer DASH QuestionnaireBaseline, 3, 6 and 9 months post surgeryto assess impairment (N). Higher scores denote better outcome
Canadian Occupational Performance Measure (COPM)Baseline, 3, 6 and 9 months post surgeryto assess handicap and participation (Range 1-5). Higher scores denote better outcome

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026