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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Exercise Training, Cardiac Rehabilitation, Physical Therapy, Exercise Intervention for Brachial Plexus Injury?

While there is no direct evidence for brachial plexus injury, studies show that physical therapy and exercise can improve shoulder function and reduce pain in similar conditions like rotator cuff disorders and subacromial impingement syndrome. ^{1 2 3 4 5}

Is exercise training generally safe for humans?

Exercise training, including physical activity interventions, is generally safe for humans. Studies show that while minor injuries like muscle strains can occur, serious adverse events are rare, especially when starting with low intensity and gradually increasing. Proper screening and supervision can further minimize risks. ^{6 7 8 9 10}

How is the exercise training treatment for brachial plexus injury different from other treatments?

Exercise training for brachial plexus injury is unique because it focuses on improving muscle function and range of motion through physical activities, which can help re-educate muscles and prevent muscle wasting. Unlike surgical or drug treatments, this approach emphasizes rehabilitation through movement and physical therapy techniques, making it a non-invasive option. ^{11 12 13 14 15}

Eligibility Criteria

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 am between 18 and 60 years old.

I have a confirmed nerve injury in my shoulder area.

Exclusion Criteria

I have a condition affecting my elbow or hand function.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development and Assessment of a Patient "Journey Guide" for Adult Traumatic Brachial Plexus Injury. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of supervised physiotherapy versus home exercise in subjects with rotator cuff disorders treated surgically: A systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

THE EFFECT OF AXIOSCAPULAR AND ROTATOR CUFF EXERCISE TRAINING SEQUENCE IN PATIENTS WITH SUBACROMIAL IMPINGEMENT SYNDROME: A RANDOMIZED CROSSOVER TRIAL. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Pain Neuroscience Education on Active Rehabilitation Following Arthroscopic Rotator Cuff Repair: A CONSORT-Compliant Prospective Randomized Single-Blind Controlled Trial. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the American Association of Cardiovascular and Pulmonary Rehabilitation Exercise Risk Stratification Classification Tool Without Exercise Testing. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Physical therapeutic treatment for traumatic brachial plexus injury in adults: A scoping review. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Clinical research of comprehensive rehabilitation in treating brachial plexus injury patients. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Pre-/postoperative therapy for adult plexus injury. [2009]

14. United States pubmed.ncbi.nlm.nih.gov

The effect of a high-quality nursing model employing low-frequency pulse electrical stimulation combined with early systemic functional exercises on the function of the affected limb in brachial plexus injury patients. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Treatment of a brachial plexus injury using kinesiotape and exercise. [2010]