Brachial Plexus InjuryPhase 2NCT05859178
Exercise Training for Brachial Plexus Injury Following Nerve Transfer
A Phase 2 study testing Exercise group in people with Brachial Plexus Injury, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- Exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2026to 4 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults age 18-60
- electrodiagnostically confirmed brachial plexus injury affecting the musculocutaneous nerve
- able to consent for participation.
Who cannot join
- individuals with additional neurological or musculoskeletal conditions that would affect elbow and hand function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Training to Improve Nerve Regeneration and Function in Patients With Brachial Plexus Injury Following Nerve Transfer - a Randomized Controlled Clinical 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.
Read the 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
- Being tested
- Exercise group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Exercise group |
| Control group | Experimental | Participants will carry out a stretch exercise routine that is not known to have any effect on nerve regeneration. Receives: Other: Exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor nerve conduction study
compound muscle action potential of the biceps muscle. Range: 0-7 mV. Higher scores signify better nerve regeneration
Measured: Baseline, 3, 6 and 9 months post surgery
Secondary outcomes (4)
magnetic resonance imaging (MRI)
muscle bulk of the biceps. Measure in cubic cm. Higher score signifies better nerve regeneration.
Measured: Baseline, 3, 6 and 9 months post surgery
dual energy x-rays absorptiometry (DEXA)
bone density - humerus (g/sq. m). Higher scores denote better outcome
Measured: Baseline, 3, 6 and 9 months post surgery
quantitative force measurement for elbow flexion using dynamometer DASH Questionnaire
to assess impairment (N). Higher scores denote better outcome
Measured: Baseline, 3, 6 and 9 months post surgery
Canadian Occupational Performance Measure (COPM)
to assess handicap and participation (Range 1-5). Higher scores denote better outcome
Measured: Baseline, 3, 6 and 9 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Mar 2026 (estimated)
- Primary completion4 May 2026
- Study completion4 May 2026
Why it stopped: logistical issues, study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital, Glenrose Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859178
- Sponsor's protocol ID
- Pro00128785
- Status last verified
- May 2026
- First submitted
- 5 Apr 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training to Improve Nerve Regeneration and Function in Patients With Brachial Plexus Injury Following Nerve Transfer - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05859178
- Acronym / sponsor ID
- Pro00128785
- Conditions
- Brachial Plexus Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistical issues, study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital, Glenrose Foundation
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise groupEach 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. |
| Control group | Experimental | Other: Exercise groupParticipants will carry out a stretch exercise routine that is not known to have any effect on nerve regeneration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults age 18-60
- electrodiagnostically confirmed brachial plexus injury affecting the musculocutaneous nerve
- able to consent for participation.
Key exclusion criteria (1 listed)
- individuals with additional neurological or musculoskeletal conditions that would affect elbow and hand function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise groupAlong 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. | Other | Control group, Exercise group |
Primary outcome
Motor nerve conduction study
Time frame: Baseline, 3, 6 and 9 months post surgery
compound muscle action potential of the biceps muscle. Range: 0-7 mV. Higher scores signify better nerve regeneration
4 secondary outcomes
magnetic resonance imaging (MRI)
Time frame: Baseline, 3, 6 and 9 months post surgery
dual energy x-rays absorptiometry (DEXA)
Time frame: Baseline, 3, 6 and 9 months post surgery
quantitative force measurement for elbow flexion using dynamometer DASH Questionnaire
Time frame: Baseline, 3, 6 and 9 months post surgery
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, 3, 6 and 9 months post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise group in people with Brachial Plexus Injury, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor nerve conduction study (time frame: Baseline, 3, 6 and 9 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.