NCT05859178

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
38mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026May 2029

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2.8 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

April 5, 2023

Last Update Submit

February 4, 2026

Conditions

Brachial Plexus Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • magnetic resonance imaging (MRI)

    Baseline, 3, 6 and 9 months post surgery

  • dual energy x-rays absorptiometry (DEXA)

    Baseline, 3, 6 and 9 months post surgery

  • quantitative force measurement for elbow flexion using dynamometer DASH Questionnaire

    Baseline, 3, 6 and 9 months post surgery

  • Canadian Occupational Performance Measure (COPM)

    Baseline, 3, 6 and 9 months post surgery

Study Arms (2)

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.

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.

Other: Exercise group

Interventions

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.

Control groupExercise group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults age 18-60
  • electrodiagnostically confirmed brachial plexus injury affecting the musculocutaneous nerve
  • able to consent for participation.

You may not qualify if:

  • individuals with additional neurological or musculoskeletal conditions that would affect elbow and hand function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C9, Canada

Location

Central Study Contacts

Ming Chan

CONTACT

780-492-9343ming.chan@ualberta.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The assessor will not be involved in treatment delivery. Participants in the control group will carry out sham exercise.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 15, 2023

Study Start

March 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)