Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
1 other identifier
interventional
83
1 country
1
Brief Summary
A randomized control trial examining the relationship between changes in hand function and brain plasticity following intensive therapy. Two treatment approaches are used: constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at TC Columbia University to be child friendly and draw upon our extensive experience with constraint-induced movement therapy in children with cerebral palsy. Our center has been providing interventions camps for children with cerebral palsy since 1998. The interventions are performed in a 15 day day-camp setting with several children and at least one interventionist per child. The aim of the intervention is to improve the use of the affected hand and quality of overall movement in a fun, social setting. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedResults Posted
Study results publicly available
December 16, 2024
CompletedDecember 16, 2024
October 1, 2024
4.3 years
September 27, 2016
August 5, 2024
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Jebsen-Taylor Test of Hand Function
The JTTHF measures the time taken to complete six unimanual tasks, which include flipping cards, moving small objects, and lifting cans. The total score is the amount of time taken (in seconds) to complete all tasks. A lower score means a better outcome.
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Assisting Hand Assessment
The AHA is a validated test for measuring bimanual hand use in children with UE impairments. The AHA measures the use of the more affected hand in bimanual activities during a play-like testing session. Sessions were videotaped and scored off-site by a blinded evaluator. The AHA has excellent validity, reliability (0.97-0.99) and responsiveness to change. The AHA units were used for the analysis (range 0-100). The smallest detectable difference (SDD) for AHA is an improvement of at least 5 units. A higher score means a better outcome.
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Box and Blocks Test
The BBT measures how many blocks (2.5 cm3) an individual can move from one box, over a barrier, to an adjacent box in 1 min. Both hands were tested. The BBT is valid and reliable for children with CP. A higher score means a better outcome.
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Secondary Outcomes (1)
Canadian Occupational Performance Measure
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Study Arms (2)
Constraint Induced Movement Therapy
EXPERIMENTALProcedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Hand-Arm Bimanual Intensive Therapy
EXPERIMENTALProcedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of unilateral cerebral palsy
You may not qualify if:
- Current medical illness unrelated to CP
- Seizure disorder
- Current use of medications know to lower the seizure threshold
- Metallic object(s) in body, other than dental fillings
- Pregnancy
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Teachers College, Columbia University Center for Cerebral Palsy Research
New York, New York, 10027, United States
Related Publications (7)
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: 17044964BACKGROUNDGordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
PMID: 21950396BACKGROUNDCharles 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: 16836774RESULTGordon 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: 16510616RESULTGordon 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: 17979861RESULTGordon 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: 21700924RESULTFriel KM, Ferre CL, Brandao M, Kuo HC, Chin K, Hung YC, Robert MT, Flamand VH, Smorenburg A, Bleyenheuft Y, Carmel JB, Campos T, Gordon AM. Improvements in Upper Extremity Function Following Intensive Training Are Independent of Corticospinal Tract Organization in Children With Unilateral Spastic Cerebral Palsy: A Clinical Randomized Trial. Front Neurol. 2021 May 3;12:660780. doi: 10.3389/fneur.2021.660780. eCollection 2021.
PMID: 34012418RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were not an equal number of participants with each CST connectivity pattern. Although we did have a large number of participants with ipsilateral connectivity, we had a small number of children with purely a contralateral pattern. However, the responsiveness of these individuals across studies is not in doubt, and the findings held true even when the contralateral and bilateral groups were combined.
Results Point of Contact
- Title
- Dr. Andrew M. Gordon
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Gordon, Ph.D.
Teachers College, Columbia University
- PRINCIPAL INVESTIGATOR
Kathleen Friel, Ph.D.
Burke Neurological Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2016
First Posted
September 29, 2016
Study Start
September 1, 2014
Primary Completion
January 1, 2019
Study Completion
January 31, 2019
Last Updated
December 16, 2024
Results First Posted
December 16, 2024
Record last verified: 2024-10