Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

Neonatal Brachial Plexus Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765034
• Other study ID #: CCI-10-00255
• Status: Completed
• Phase: N/A
• Start date: January 1, 2010
• Est. completion date: December 31, 2014

Study information

• Verified date: December 2018
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Brachial Plexus Palsy

Intervention

Behavioral:
• Constrain-induced Movement Therapy
8-week therapy program utilizing constraint of the unaffected arm
• Usual Occupational Therapy
8-week therapy program without constraint of the unaffected arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline at 8 weeks and 16 weeks