Exercise Training for Brachial Plexus Injury

Overseen By Ming Chan, MD, FRCPC

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Neurological, musculoskeletal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise training (also known as cardiac rehabilitation or physical therapy) can benefit individuals with brachial plexus injuries, which impact the nerves controlling arm and hand movements. Researchers seek to discover whether exercises like hand grip workouts can accelerate nerve healing and enhance muscle and bone strength. Participants will either engage in these specific exercises or follow a stretching routine. Individuals with a confirmed brachial plexus injury affecting the musculocutaneous nerve who can provide consent are suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise training is safe for humans?

Research shows that exercise can be safe and beneficial for people with brachial plexus injuries. Studies have found that exercise significantly improves muscle strength and sensation, allowing most individuals to perform these exercises without issues.

Exercise training includes activities that strengthen muscles and enhance their function, often aiding recovery from injuries like brachial plexus. The exercises used in these studies have not caused serious side effects. Instead, they strengthen muscles and bones and improve their function.

In summary, current research indicates that exercise training for brachial plexus injuries is safe and offers a promising recovery method without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about this trial because it explores how exercise training can aid recovery in brachial plexus injuries, a nerve injury typically managed with physical therapy, surgery, or pain medications. The unique feature of this approach is the use of an electronic hand grip device that offers adjustable resistance tailored to each participant's strength, aiming to specifically activate the ulnar nerve muscles. This method is different from typical stretching or passive exercises, as it actively engages specific muscles, potentially enhancing nerve regeneration and functional recovery. The trial seeks to find out whether this targeted exercise regimen could become an effective, non-invasive treatment option for those with brachial plexus injuries.

What evidence suggests that exercise training is effective for brachial plexus injury?

Research has shown that exercise can benefit individuals with brachial plexus injury. Studies have found that rehabilitation, including exercise, improves strength, movement, and overall function. Exercise also aids in rebuilding muscle and bone often lost after nerve injury. In animal studies, exercise even accelerated nerve regrowth. This trial will compare two approaches: participants in the exercise group will perform hand grip exercises, while those in the control group will follow a stretch exercise routine. Although these results are promising, confirming them in human studies is crucial to ensure similar benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with a specific nerve injury in the arm called brachial plexus injury, confirmed by special nerve tests. Participants must be able to give consent. Those with other conditions affecting arm and hand function cannot join.

Inclusion Criteria

Able to consent for participation

I have a confirmed nerve injury in my shoulder area.

Exclusion Criteria

I have a condition affecting my elbow or hand function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hand grip exercise for 30 minutes a day, 5 days a week for a total of 12 weeks

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Assessments at 3, 6, and 9 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training

Trial Overview

The study is testing if exercise training can help people recover from brachial plexus injuries by speeding up nerve healing and improving muscle and bone health. It's a randomized controlled trial, meaning participants are randomly assigned to either the exercise group or a control group.

How Is the Trial Designed?

Group I: Exercise group Experimental Treatment 1 Intervention

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 II: Control group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Royal Alexandra Hospital

Collaborator

Trials

20

Recruited

9,300+

Glenrose Foundation

Collaborator

Trials

10

Recruited

2,500+

Published Research Related to This Trial

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

The journey guide, an educational tool created for patients with traumatic brachial plexus injury (BPI), received a high satisfaction score of 8.4 out of 10, indicating it effectively addresses patient education needs and improves understanding of their condition.

Qualitative feedback from 19 participants highlighted that the guide is particularly useful immediately after injury and serves as an effective organizational tool, although suggestions for improvement included enhancing visual elements and fostering community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Assessment of a Patient "Journey Guide" for Adult Traumatic Brachial Plexus Injury. Navarro, B., Liebendorfer, A., Voorhees, M., et al.[2023]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

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