Constraint Therapy for Brachial Plexus Birth Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorBoston Children's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Constraint Therapy

    Other intervention

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Constraint TheraphyExperimental treatment 1 intervention
Group B: Normal TherapyNo intervention 0 interventions

Trial outcomes

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.

Time frame
8-18 months of age

Secondary outcomes

1

Active Movement Scale

The Active Movement Scale (AMS) is an ordinal clinical scale used to quantify active joint motion in infants and children with brachial plexus birth injury. The scale evaluates active movement across several joints of the upper extremity including shoulder abduction, shoulder external rotation, elbow flexion, elbow extension, wrist extension, and finger movements. Movements are scored on an 8-point scale (0-7) based on the presence and range of active motion both with gravity eliminated and against gravity. A higher score indicates more function of the affected limb. Scores are assigned through standardized clinical examination performed by trained clinicians. The AMS has been widely used in BPBI populations and demonstrates strong inter-rater reliability and validity for assessing motor recovery following brachial plexus injury.

Time frame
0-18 months of age
2

Toronto Score

The Toronto Test Score is a standardized clinical assessment used to evaluate motor recovery in infants with brachial plexus birth injury. The instrument evaluates muscle function across multiple upper extremity muscle groups using standardized manual muscle testing and movement observation. Individual muscle group scores from 0 to 2 are combined to generate domain-specific and total scores ranging from 0 to 10, which reflects overall upper extremity motor function. A higher score indicates more function of the affected limb The Toronto Score has been used extensively in BPBI clinical research and longitudinal outcome studies and provides a complementary measure of motor recovery alongside the AMS.

Time frame
0-18 months of age
3

Goniometric Range of Motion (AROM)

Active range of motion of the affected upper extremity will be assessed using standard goniometric measurement techniques performed by trained clinicians. Joints assessed will include: * Shoulder abduction * Shoulder external rotation * Elbow flexion * Elbow extension * Wrist extension Goniometric measurements provide quantitative assessment of joint mobility and are commonly used in clinical evaluation of children with BPBI to monitor recovery of joint-specific motor function.

Time frame
0-18 months of age
4

Wearable Activity Monitoring

Spontaneous upper extremity movement will also be evaluated using wearable activity sensors (Fibion accelerometer). Sensors will be placed on both upper extremities to capture continuous movement data during daily activities. The Fibion sensor provides objective quantification of limb activity through accelerometry-based motion detection. Metrics derived from the device will include: o Acceleration X, Y, and Z axis in m/s2 These measures will provide a continuous, objective estimate of spontaneous upper extremity use over 2-3 day data collection periods, complementing observational and clinical assessment measures.

Time frame
6-18 months of age

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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