Neonatal Brachial Plexus Palsy
Conditions
Brief 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.
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.
Interventions
BEHAVIORALConstrain-induced Movement Therapy
8-week therapy program utilizing constraint of the unaffected arm
BEHAVIORALUsual Occupational Therapy
8-week therapy program without constraint of the unaffected arm
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assisting Hand Assessment 5.0 | 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. |
Outcome results
None listed