Trial Outcomes & Findings for Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy (NCT NCT00305006)

Last Updated: 2021-06-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2021-06-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	22	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0
Overall Study Failure to complete pretest	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CIMT n=21 Participants 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.	HABIT n=21 Participants Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.	Total n=42 Participants Total of all reporting groups
Age, Continuous	6.3 years STANDARD_DEVIATION 2.2 • n=5 Participants	6.4 years STANDARD_DEVIATION 1.11 • n=7 Participants	6.3 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: Subject sample size calculation based on prior data. intention to treat (ITT) was used.

Outcome measures

Outcome measures
Measure	CIMT n=21 Participants 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.	HABIT n=21 Participants Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
Change in Score on Assisting Hand Assessment (AHA)	0.42 score Interval 0.08 to 0.76	0.56 score Interval 0.23 to 0.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CIMT n=21 Participants 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.	HABIT n=21 Participants Participants randomized to this arm were provided with 90 minutes of Hand-Arm Bimanual Intensive Therapy (HABIT), which requires that tasks are progressed bimanually.
Change in Score on the Jebsen-Taylor Test of Hand Function (JTTHF)	-141.7 score Interval -195.4 to -88.0	-131.2 score Interval -185.0 to -77.5

Adverse Events

CIMT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HABIT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Gordon

Teachers College, Columbia University

Phone: 212-678-3326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place