Cerebral Palsy, Hemiplegia, Children, Pediatric
Conditions
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
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.
Detailed 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/.
Interventions
90 hours
PROCEDUREHand-Arm Bimanual Intensive Therapy (HABIT)
90 hours
Sponsors
Thrasher Research Fund
Emory University
Teachers College, Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on Assisting Hand Assessment (AHA) | Baseline, 6 months | 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. |
| Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF) | Baseline, 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from clinics in the NYC area, and online support groups from June 2007 to July 2009. Participants were firs screened via e-mail and/or telephone and potentially invited to receive an on-site physical examination or an examination videotaped by their physical occupational therapist.
Participants by arm
| Arm | Count |
|---|---|
| CIMT 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. | 21 |
| HABIT Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to complete pretest | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | HABIT | Total | CIMT |
|---|---|---|---|
| Age, Continuous | 6.4 years STANDARD_DEVIATION 1.11 | 6.3 years STANDARD_DEVIATION 2 | 6.3 years STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 27 Participants | 15 Participants |
| Sex: Female, Male Female | 10 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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.
Time frame: Baseline, 6 months
Population: Subject sample size calculation based on prior data. intention to treat (ITT) was used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CIMT | Change in Score on Assisting Hand Assessment (AHA) | 0.42 score |
| HABIT | Change in Score on Assisting Hand Assessment (AHA) | 0.56 score |
Comparison: ANOVAp-value: <0.01ANOVA
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.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CIMT | Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF) | -141.7 score |
| HABIT | Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF) | -131.2 score |