An interventional study of Constraint Therapy in Brachial Plexus Birth Palsy, sponsored by Boston Children's Hospital. Not yet recruiting. Open to participants aged Up to 18 Months. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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:
Infants with brachial plexus birth injury (BPBI) frequently demonstrate early asymmetry in upper extremity use during a critical period of neurodevelopment. Although constraint-induced movement therapy (CIMT) is well established in hemiplegic cerebral palsy and widely used in pediatric neurologic rehabilitation, high-quality evidence supporting its use in infants with BPBI is lacking. Given the potential for early asymmetric motor experience to influence long-term functional development, rigorous evaluation of this intervention in BPBI is needed. The CRIB study will be a randomized controlled trial evaluating the efficacy of a 5-week CIMT program compared to usual therapy in infants with BPBI. This trial will determine whether early CIMT improves spontaneous bimanual upper extremity use and whether gains are sustained at 6 months using blinded, standardized assessments. Results will inform evidence-based rehabilitation strategies during a critical developmental window.
Primary Aim: To determine whether a 5-week program of CIMT improves spontaneous bimanual motor function in infants with BPBI compared with usual therapy at Boston Children's Hospital.
Primary Hypothesis: Infants randomized to CIMT will demonstrate greater early improvement in spontaneous use of the affected upper extremity from baseline to post-intervention (around 1month), with sustained improvement from post-intervention (around 1 month) to 6 months, compared to infants receiving usual therapy.
Secondary Aims and Hypotheses:
Aim 1: To evaluate the effect of CIMT on additional standardized measures of upper extremity function in infants with BPBI compared to usual therapy.
Hypothesis: Infants randomized to CIMT will demonstrate greater improvements in motor function compared to usual therapy across both early and sustained follow-up timepoints.
Aim 2: To evaluate whether wearable activity monitoring using the Fibion sensor provides a quantitative measure of spontaneous upper-extremity use in infants with BPBI at Boston Children's Hospital.
Hypothesis: Wearable activity monitoring using the Fibion tracker will detect reduced spontaneous movement of the affected upper extremity compared with the unaffected extremity at baseline, and will demonstrate increased activity of the affected extremity following intervention.
Aim 3: To evaluate the parental perceived outcomes of their childs real-world arm use over time using the modified Canadian occupational performances measure (COPM)
Hypothesis: Patients undergoing constraint therapy will have higher COPM scoring indicating improved real world function compared to patients that did not undergo therapy
Aim 4: To evaluate if quantifiable central nervous system changes occur in patients with BPBI undergoing constraint therapy compared to the Normal Brain Registry magnetic resonance imaging
Hypothesis: Patients undergoing constraint therapy will show gross structural and neural activity reorganization in the central nervous systems compared do unaffected patients and patients that did not undergo therapy
Boston Children's Hospital is the lead sponsor of 607 studies on the registry; 148 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 19 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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
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
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
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
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
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
Modified Canadian Occupational Performance Measure (COPM)
A 4-question COPM style measure will be used as a compliment to the Mini-AHA by assessing parental perceived outcomes of their child's real-world arm use over time. This measure uses a numerical anchored rating scale grading criteria from 1 to 10 to rate performance and satisfaction of the affected arm use as a family-centered outcome of progressive functional recovery.
Time frame: 18 months of age
Shoulder Ultrasound (US)
Dynamic shoulder ultrasound will be collected to note which patients at enrollment have morphological changes to their shoulder joint which may prevent full shoulder motion. Measures such as alpha angle, percent of posterior humeral head displacement, humeral head size, ossification center identification, and overall humeral head coverage of the glenoid.
Time frame: Pre-intervention
Magnetic Resonance Imaging (MRI)
Multiplanar sequenced T1 and T2 weighted MRI's will be paired with a water diffusion protocol to assess neural activity as well as gross structural differences compared to a control cohort of unaffected, age and sex matched patients\[EV9.1\]\[EV9.2\]. A feed and wrap protocol will be used to avoid the risk of anesthesia. Scans will be reviewed by a neuroradiologist, and objective radiological measures will be captured for quantitative assessment.
Time frame: 18 months of age
Wearable Activity Monitoring (2)
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: \- Angular velocity via Gyroscope in degrees/s 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
Wearable Activity Monitoring (3)
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: * Frequency of affected-limb use in % * Asymmetry Index for gross movement in % 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
No study locations are listed for this record.
Plan to share: No — This clinical trial is a single institution study that will have no outside collaborations. Individual participant data collected during this study will not be shared with other researchers outside of the study team. Data will be maintained securely and used for the purposes described in the study protocol, with participant confidentiality and privacy protected in accordance with applicable institutional and regulatory requirements. Deidentified data may be available upon request upon conclusion of the study.
Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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