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Completed

NCT Number: NCT03765034

Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

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.

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Key information

Conditions

Neonatal Brachial Plexus Palsy Birth Injuries Brachial Plexus Neuropathies Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Wounds and Injuries

Age range

12 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constrain-induced Movement Therapy

Behavioral

8-week therapy program utilizing constraint of the unaffected arm

Usual Occupational Therapy

Behavioral

8-week therapy program without constraint of the unaffected arm

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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