Constraint Therapy for Brachial Plexus Birth Injury

NCT07868029 | Not Yet Recruiting

• 1 other identifier: IRB-P00054703
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trail is to learn if constraint physical therapy is a better treatment than normal physical therapy for infants with a brachial plexus birth injury. The main question it aims to answer is: If constraint physical therapy can give participants earlier and better function than normal physical therapy. Researchers will compare participants receiving constraint physical therapy to participants receiving normal therapy to see if their strength and recovery is better. Participants/families will:

• Undergo constraint or normal physical therapy for 5 weeks
• Wear a research motion tracking device to measure movement
• Answer questionnaires about if they see improvement in arm use
• Visit clinical 1 and 6 months after therapy for checkups and tests
• Obtain medical imaging of their shoulders, brain and spinal cord

Conditions

Brachial Plexus Birth Palsy

Keywords

Brachial plexus birth injury; Constraint-induced movement therapy; Constraint movement therapy; BPBI

Outcome Measures

Primary Outcomes (1)

• Mini-Assisting Hand Assessment

  The primary outcome will be spontaneous bimanual upper-extremity function as measured by the Mini-Assisting Hand Assessment (Mini-AHA). The Mini-Assisting Hand Assessment (Mini-AHA) will be used as a standardized observational assessment for patients 8-12 months old. The Mini-AHA is an adaptation of the Assisting Hand Assessment (AHA) specifically designed for children approximately 8-18 months of age who have unilateral upper limb impairment. The Mini-AHA uses a structured play session lasting 10-15 minutes during which the child interacts with a standardized set of age-appropriate toys designed to elicit a range of bimanual actions (e.g., grasping, stabilizing, manipulating). Sessions are video-recorded and later scored by certified Mini-AHA/AHA raters using a detailed scoring manual on a scale from 0 to 100, with a higher score indicating more function of the limb.

  8-18 months of age

Secondary Outcomes (9)

• Active Movement Scale

  0-18 months of age

• Toronto Score

  0-18 months of age

• Goniometric Range of Motion (AROM)

  0-18 months of age

• Wearable Activity Monitoring

  6-18 months of age

• Modified Canadian Occupational Performance Measure (COPM)

  18 months of age

Study Arms (2)

Constraint Theraphy

EXPERIMENTAL

Participants in the constraint therapy group will undergo 5 weeks of intensive therapy (3 weeks constrained and 2 weeks un-constrained) 3 times per week for 2-hour sessions each. During the days not in outpatient therapy, at home therapy will be administered for 2 hours by their caretaker.

Other: Constraint Therapy

Normal Therapy

NO INTERVENTION

These participants will not receive any modification to their normal physical therapy course that is currently recommended as standard of care. This course can include early intervention, at home exercises, and out-patient physical therapy of unspecified quantities.

Interventions

Constraint Therapy OTHER

Weeks 1-3: Force use stage Direct therapy - 2 times per week, 2-hour sessions Parent home program - 2 hours daily, sessions of therapy should be at least 15 minutes each, non-injured arm movement is restricted for the entirety of these parent guided sessions Sessions should be done wearing movement restrictive brace on non-affected arm Weeks 4-5: Bilateral training phase Direct occupational or therapy 2 times per week, 2-hour sessions Parent home program - 2-hour daily sessions of therapy, at least 15 minutes per session. No active constraint

Constraint Theraphy

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of a unilateral upper trunk brachial plexus birth injury (C5/6 or C5-7) with intact distal function
• Age 6 months to 12 months
• Willingness to participate and be randomized

You may not qualify if:

• Prior upper extremity surgery related to brachial plexus birth injury
• Glenohumeral dysplasia requiring an operation during the study timeline
• Known neurologic/neuromuscular disorder or global developmental delay that would confound upper extremity motor assessment

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related Publications (4)

• Gotlieb-Horowitz M, Robbins V, Ferrante V, DeRosa TM, Behbahani M, Koehler SM. Uses of constraint-induced movement therapy (CIMT) in patients with brachial plexus birth injuries (BPBI). J Hand Microsurg. 2025 Jul 3;17(5):100316. doi: 10.1016/j.jham.2025.100316. eCollection 2025 Sep.

  PMID: 40687301 BACKGROUND

• Jamali AR, Amini M. The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. Iran J Child Neurol. 2018 Fall;12(4):16-27.

  PMID: 30279705 BACKGROUND

• Werner JM, Berggren J, Loiselle J, Lee GK. Constraint-induced movement therapy for children with neonatal brachial plexus palsy: a randomized crossover trial. Dev Med Child Neurol. 2021 May;63(5):545-551. doi: 10.1111/dmcn.14741. Epub 2020 Nov 21.

  PMID: 33219706 BACKGROUND

• Cui Z, Liu L, Chen X, Zeng H, Zheng S, Wu D. Single Blind Randomized Controlled Trial of Modified Constraint-Induced Movement Therapy in Infants With the Sequelas of Unilateral Brachial Plexus Injury. Front Hum Neurosci. 2022 May 30;16:900214. doi: 10.3389/fnhum.2022.900214. eCollection 2022.

  PMID: 35706479 BACKGROUND

MeSH Terms

Interventions

Constraint Induced Movement Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Andrea S Bauer, MD

  Boston Children's Hospital, Harvard School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan S Vienneau, BS

CONTACT

617-919-6065; evan.vienneau@childrens.harvard.edu

Sara Olenich, MS

CONTACT

617-355-1119; sara.olenich@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Orthopedic Hand and Nerve Surgeon

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share