Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00305006
Other study ID # 08126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2007
Est. completion date February 2011

Study information

Verified date May 2021
Source Teachers College, Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1998 with constraint-induced movement therapy in children with cerebral palsy. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. We have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date February 2011
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 30 Months to 14 Years
Eligibility Inclusion Criteria: willingness to agree to intervention and testing procedures and travel to the University for participation and testing. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Constraint-Induced Movement Therapy (CIMT)
90 hours
Hand-Arm Bimanual Intensive Therapy (HABIT)
90 hours

Locations

Country Name City State
United States Teachers College, Columbia University New York New York

Sponsors (3)

Lead Sponsor Collaborator
Teachers College, Columbia University Emory University, Thrasher Research Fund

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2