Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

Sponsor

Children's Hospital Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT03765034

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Brachial Plexus Palsy	Behavioral: Constrain-induced Movement Therapy Behavioral: Usual Occupational Therapy	N/A

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

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 31, 2014

Actual Study Completion Date :

Dec 31, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Constraint-induced Movement Therapy A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.	Behavioral: Constrain-induced Movement Therapy 8-week therapy program utilizing constraint of the unaffected arm Behavioral: Usual Occupational Therapy 8-week therapy program without constraint of the unaffected arm
Active Comparator: Usual Occupational Therapy Usual and standard care occupational therapy is administered for 8 weeks.	Behavioral: Usual Occupational Therapy 8-week therapy program without constraint of the unaffected arm

Arm

Intervention/Treatment

Experimental: Constraint-induced Movement Therapy

A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.

Behavioral: Constrain-induced Movement Therapy

8-week therapy program utilizing constraint of the unaffected arm

Behavioral: Usual Occupational Therapy

8-week therapy program without constraint of the unaffected arm

Active Comparator: Usual Occupational Therapy

Usual and standard care occupational therapy is administered for 8 weeks.

Behavioral: Usual Occupational Therapy

8-week therapy program without constraint of the unaffected arm

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

julie werner, Clinical Scientist, Children's Hospital Los Angeles

ClinicalTrials.gov Identifier:

NCT03765034

Other Study ID Numbers:

CCI-10-00255

First Posted:

Dec 5, 2018

Last Update Posted:

Dec 5, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neonatal Brachial Plexus Palsy

Study Results

No Results Posted as of Dec 5, 2018