Neonatal Brachial Plexus PalsyNCT03765034
Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
A study testing Constrain-induced Movement Therapy and Usual Occupational Therapy in people with Neonatal Brachial Plexus Palsy, run by Children's Hospital Los Angeles.
Trial summary
This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one. Read more about this study
- Who is it for?
- Ages 12 months to 5 years
- Conditions the study is for
- Neonatal Brachial Plexus Palsy
- What is being tested?
- Constrain-induced Movement Therapy and Usual Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant has perinatal brachial plexus injury
- Participant walking at time of study inception
- Ability to cooperate with interventions and assessment
- Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study
Who cannot join
- Co-morbid diagnosis not related to perinatal brachial plexus injury
- Flaccidity of the involved upper extremity or no observable hand function
- Planned surgery or drug intervention during the study period
- Allergy or intolerance to constraint intervention materials
About this study
Official title: Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial
This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.
Read the detailed description
Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.
Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.
- Conditions
- Neonatal Brachial Plexus Palsy
- Being tested
- Constrain-induced Movement Therapy, Usual Occupational Therapy
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constrain-induced Movement TherapyBehavioural
8-week therapy program utilizing constraint of the unaffected arm
Usual Occupational TherapyBehavioural
8-week therapy program without constraint of the unaffected arm
| Study group | Role | What they receive |
|---|---|---|
| Constraint-induced Movement Therapy | Experimental | A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks. Receives: Behavioral: Constrain-induced Movement Therapy; Behavioral: Usual Occupational Therapy |
| Usual Occupational Therapy | Active comparator | Usual and standard care occupational therapy is administered for 8 weeks. Receives: Behavioral: Usual Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment 5.0
Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100.
Measured: change from baseline at 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2010
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, julie werner, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765034
- Sponsor's protocol ID
- CCI-10-00255
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03765034
- Acronym / sponsor ID
- CCI-10-00255
- Conditions
- Neonatal Brachial Plexus Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 5 Dec 2018 (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.
This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.
Detailed description
Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.
Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-induced Movement Therapy | Experimental | Behavioral: Constrain-induced Movement Therapy, Behavioral: Usual Occupational TherapyA passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks. |
| Usual Occupational Therapy | Active comparator | Behavioral: Usual Occupational TherapyUsual and standard care occupational therapy is administered for 8 weeks. |
Who may qualify
- Ages
- 12 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participant has perinatal brachial plexus injury
- Participant walking at time of study inception
- Ability to cooperate with interventions and assessment
- Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study
Key exclusion criteria (4 listed)
- Co-morbid diagnosis not related to perinatal brachial plexus injury
- Flaccidity of the involved upper extremity or no observable hand function
- Planned surgery or drug intervention during the study period
- Allergy or intolerance to constraint intervention materials
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 |
|---|---|---|
| Constrain-induced Movement Therapy8-week therapy program utilizing constraint of the unaffected arm | Behavioural | Constraint-induced Movement Therapy |
| Usual Occupational Therapy8-week therapy program without constraint of the unaffected arm | Behavioural | Constraint-induced Movement Therapy, Usual Occupational Therapy |
Primary outcome
Assisting Hand Assessment 5.0
Time frame: change from baseline at 8 weeks and 16 weeks
Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Constrain-induced Movement Therapy and Usual Occupational Therapy in people with Neonatal Brachial Plexus Palsy, run by Children's Hospital Los Angeles.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting Hand Assessment 5.0 (time frame: change from baseline at 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2018.