Brachial Plexus Birth PalsyCRIBNCT07868029
Constraint Therapy for Brachial Plexus Birth Injury
A study testing Constraint Therapy in people with Brachial Plexus Birth Palsy, run by Boston Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Brachial Plexus Birth Palsy
- What is being tested?
- Constraint Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Constraint Response in Infants With Brachial Plexus Birth Injury
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:
Read more
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
Read the detailed description
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
- Conditions
- Brachial Plexus Birth Palsy
- Being tested
- Constraint Therapy
- Keywords
- Brachial plexus birth injury, Constraint-induced movement therapy, Constraint movement therapy, BPBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-18 months of age
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus Birth PalsyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Bauer, Boston Children's Hospital
- Investigators
- Andrea S Bauer, MD, Principal investigator, Boston Children's Hospital, Harvard School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868029
- Sponsor's protocol ID
- IRB-P00054703
- Acronym
- CRIB
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 40687301Jamali 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.
PubMed 30279705Werner 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.
PubMed 33219706Cui 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.
PubMed 35706479
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint Response in Infants With Brachial Plexus Birth Injury
- ClinicalTrials.gov ID
- NCT07868029
- Acronym / sponsor ID
- CRIB / IRB-P00054703
- Conditions
- Brachial Plexus Birth Palsy
- Keywords
- Brachial plexus birth injury, Constraint-induced movement therapy, Constraint movement therapy, BPBI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 9 Oct 2026 (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.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint Theraphy | Experimental | Other: Constraint TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Constraint TherapyWeeks 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 | Other | Constraint Theraphy |
Primary outcome
Mini-Assisting Hand Assessment
Time frame: 8-18 months of age
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.
9 secondary outcomes
Active Movement Scale
Time frame: 0-18 months of age
Toronto Score
Time frame: 0-18 months of age
Goniometric Range of Motion (AROM)
Time frame: 0-18 months of age
Wearable Activity Monitoring
Time frame: 6-18 months of age
Modified Canadian Occupational Performance Measure (COPM)
Time frame: 18 months of age
Shoulder Ultrasound (US)
Time frame: Pre-intervention
Magnetic Resonance Imaging (MRI)
Time frame: 18 months of age
Wearable Activity Monitoring (2)
Time frame: 6-18 months of age
Wearable Activity Monitoring (3)
Time frame: 6-18 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 40687301Gotlieb-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.
- Background: PubMed 30279705Jamali 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.
- Background: PubMed 33219706Werner 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.
- Background: PubMed 35706479Cui 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.
- Individual participant dataSharing planned: 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.
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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.
Andrea S Bauer, MD principal investigator
Boston Children's Hospital, Harvard School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Therapy in people with Brachial Plexus Birth Palsy, run by Boston Children's Hospital.
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 3 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan S Vienneau, BS (617-919-6065, evan.vienneau@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Assisting Hand Assessment (time frame: 8-18 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868029, which also lists 4 linked publications.
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 9 Oct 2026.