Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

NCT00305006 | Completed Results

• 1 other identifier: 08126
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial of bimanual training. 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.

Conditions

Cerebral Palsy; Hemiplegia; Children; Pediatric

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

Outcome Measures

Primary Outcomes (2)

• Change in Score on Assisting Hand Assessment (AHA)

  The Assisting Hand Assessment (AHA) quantifies the effectiveness with which a child with unilateral disability uses his/her affected (assisting) hand in bimanual activity. Scores range from 0-100 units, with higher scores signifying better bimanual performance.

  Baseline, 6 months

• Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)

  The Jebsen-Taylor Test of Hand Function (JTTHF) is a standardized test of simulated functional tasks quantifying the time to complete a battery of unimanual tasks. The activities performed include flipping index cards, object placement, simulated eating, stacking checkers, and manipulating empty and full cans. Scores range from 0-1080 seconds, with a lower score signifying better hand function.

  Baseline, 6 months

Study Arms (2)

CIMT Intervention

EXPERIMENTAL

Participants randomized to this arm were provided with 90 minutes of Constraint-Induced Movement Therapy (CIMT), which requires hand restraint and progression of unimanual tasks.

Procedure: Constraint-Induced Movement Therapy (CIMT)

HABIT Intervention

EXPERIMENTAL

Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.

Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT)

Interventions

Constraint-Induced Movement Therapy (CIMT) PROCEDURE

90 hours

CIMT Intervention

Hand-Arm Bimanual Intensive Therapy (HABIT) PROCEDURE

90 hours

HABIT Intervention

Eligibility Criteria

• Age: 30 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• 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
• Emory University: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (9)

• 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

• Charles JR, Wolf SL, Schneider JA, Gordon AM. Efficacy of a child-friendly form of constraint-induced movement therapy in hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2006 Aug;48(8):635-42. doi: 10.1017/S0012162206001356.

  PMID: 16836774 BACKGROUND

• Gordon AM, Charles J, Wolf SL. Efficacy of constraint-induced movement therapy on involved upper-extremity use in children with hemiplegic cerebral palsy is not age-dependent. Pediatrics. 2006 Mar;117(3):e363-73. doi: 10.1542/peds.2005-1009.

  PMID: 16510616 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

• Steenbergen B, Charles J, Gordon AM. Fingertip force control during bimanual object lifting in hemiplegic cerebral palsy. Exp Brain Res. 2008 Mar;186(2):191-201. doi: 10.1007/s00221-007-1223-6. Epub 2008 Jan 26.

  PMID: 18224309 BACKGROUND

• Schertz M, Gordon AM. Changing the model: a call for a re-examination of intervention approaches and translational research in children with developmental disabilities. Dev Med Child Neurol. 2009 Jan;51(1):6-7. doi: 10.1111/j.1469-8749.2008.03220.x. No abstract available.

  PMID: 19087099 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

• 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 RESULT

Related Links

• Center for cerebral palsy research

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia; Habits

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Limitations and Caveats

Both groups receive treatment.

Results Point of Contact

• Title: Dr. Andrew Gordon
• Organization: Teachers College, Columbia University

ag275@columbia.edu

212-678-3326

Study Officials

• Andrew M Gordon, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: March 20, 2006
• First Posted: March 21, 2006
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2011
• Last Updated: June 1, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-05

Locations

US (1)