Bimanual Training in Children With Hemiplegia

NCT01413594 | Completed

• 1 other identifier: 11204
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial of bimanual training in children with hemiplegia. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators will test the hypothesis that bimanual training (HABIT) will result in improved hand function in children with hemiplegia.

Conditions

Hemiplegia; Cerebral Palsy; Children

Keywords

cerebral palsy; constraint-induced therapy; constraint-induced movement therapy; CP; hemiplegia; hand; forced use; motor control; children; HABIT; Hand-arm bimanual intensive therapy; bilateral training; bimanual training; functional therapy; physical therapy; occupational therapy; intensive; pediatric; development; upper extremity; hemiplegic; childhood stroke

Outcome Measures

Primary Outcomes (2)

• Change from baseline in quality of bimanual hand use at 12 months

  Changes in quality of how the two hands are used during manual activity as determined from video analysis.

  12 months

• Change from baseline in manual dexterity at 12 months

  Change from baseline in timed performance of standardized manual activities

  12 months

Secondary Outcomes (3)

• Change from baseline in upper extremity strength at 12 months

  12 months

• Change from baseline in range of upper extremity motion at 12 months

  12 months

• Change from baseline in goal achievement at 12 months

  12 months

Study Arms (2)

HABIT

EXPERIMENTAL

Hand-Arm Bimanual Intensive Therapy (HABIT)

Behavioral: HABIT

Ongoing usual and customary rehabilitation care

NO INTERVENTION

Subjects are tested over 6 months while receiving their ongoing usual and customary care schedule of physical and occupational therapy or following constraint-induced movement therapy received as usual and customary care independent of the study, and then are crossed-over to receive HABIT.

Interventions

HABIT BEHAVIORAL

90 hours of bimanual training over 3 weeks in a day camp environment

Also known as: constraint-induced movement therapy, bimanual training, occupational therapy, physical therapy

HABIT

Eligibility Criteria

• Age: 18 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \*willingness to agree to intervention and testing procedures and travel to the University for participation and testing

You may not qualify if:

• health problems not associated with CP
• uncontrollable seizures
• visual problems that would interfere with carrying out the intervention or testing
• botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study

Sponsors & Collaborators

• Teachers College, Columbia University: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (6)

• Hung YC, Casertano L, Hillman A, Gordon AM. The effect of intensive bimanual training on coordination of the hands in children with congenital hemiplegia. Res Dev Disabil. 2011 Nov-Dec;32(6):2724-31. doi: 10.1016/j.ridd.2011.05.038. Epub 2011 Jun 28.

  PMID: 21715141 BACKGROUND

• Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.

  PMID: 21700924 BACKGROUND

• Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.

  PMID: 17979861 BACKGROUND

• Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.

  PMID: 17044964 BACKGROUND

• Gordon AM, Chinnan A, Gill S, Petra E, Hung YC, Charles J. Both constraint-induced movement therapy and bimanual training lead to improved performance of upper extremity function in children with hemiplegia. Dev Med Child Neurol. 2008 Dec;50(12):957-8. doi: 10.1111/j.1469-8749.2008.03166.x. No abstract available.

  PMID: 19160464 BACKGROUND

• Gordon AM. Two hands are better than one: bimanual skill development in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2010 Apr;52(4):315-6. doi: 10.1111/j.1469-8749.2009.03390.x. Epub 2009 Oct 7. No abstract available.

  PMID: 19811524 BACKGROUND

Related Links

• Center for Cerebral Palsy Research, TC, Columbia University

MeSH Terms

Conditions

Hemiplegia; Cerebral Palsy; Habits

Interventions

Constraint Induced Movement Therapy; Occupational Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Andrew M Gordon, PhD

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 10, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

US (1)