Trial Outcomes & Findings for Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia (NCT NCT02918890)
NCT ID: NCT02918890
Last Updated: 2024-12-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
CIMT
Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Constraint-induced Movement Therapy
|
HABIT
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Hand-arm Bimanual Intensive Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
Contralateral
|
7
|
3
|
|
Overall Study
Ipsilateral
|
26
|
30
|
|
Overall Study
Bilateral
|
7
|
6
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
Baseline characteristics by cohort
| Measure |
CIMT
n=40 Participants
Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Constraint-induced Movement Therapy
|
HABIT
n=39 Participants
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Hand-arm Bimanual Intensive Therapy
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.33 years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
9.58 years
STANDARD_DEVIATION 3.42 • n=7 Participants
|
9.46 years
STANDARD_DEVIATION 3.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Jebsen-Taylor Test of Hand Function
|
405.1 seconds
STANDARD_DEVIATION 306.8 • n=5 Participants
|
402.5 seconds
STANDARD_DEVIATION 296.5 • n=7 Participants
|
403.8 seconds
STANDARD_DEVIATION 299.85 • n=5 Participants
|
|
Assisting Hand Assessment
|
56.7 logits
STANDARD_DEVIATION 20.7 • n=5 Participants
|
55.2 logits
STANDARD_DEVIATION 8.7 • n=7 Participants
|
56.0 logits
STANDARD_DEVIATION 15.83 • n=5 Participants
|
|
Box and Blocks Test
|
18.2 blocks
STANDARD_DEVIATION 10.1 • n=5 Participants
|
16.6 blocks
STANDARD_DEVIATION 9.8 • n=7 Participants
|
17.4 blocks
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Canadian Occupational Performance Measure - Performance
|
2.9 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
2.95 units on a scale
STANDARD_DEVIATION 1.07 • n=5 Participants
|
|
Canadian Occupational Performance Measure - Satisfaction
|
3.1 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)Population: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality
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.
Outcome measures
| Measure |
CIMT; Contralateral CST
n=7 Participants
Constraint Induced Movement Therapy; contralateral corticospinal tract
|
CIMT; Ipsilateral CST
n=26 Participants
Constraint Induced Movement Therapy; ipsilateral corticospinal tract
|
CIMT; Bilateral CST
n=7 Participants
Constraint Induced Movement Therapy; bilateral corticospinal tract
|
HABIT; Contralateral CST
n=3 Participants
Hand Arm Bimanual Intensive Training; contralateral corticospinal tract
|
HABIT; Ipsilateral CST
n=30 Participants
Hand Arm Bimanual Intensive Training; ipsilateral corticospinal tract
|
HABIT; Bilateral CST
n=6 Participants
Hand Arm Bimanual Intensive Training; bilateral corticospinal tract
|
|---|---|---|---|---|---|---|
|
Jebsen-Taylor Test of Hand Function
Pre-test; more affected hand
|
323.6 seconds
Interval 89.9 to 557.3
|
479.5 seconds
Interval 358.5 to 600.5
|
265.6 seconds
Interval 46.6 to 484.6
|
121.3 seconds
Interval -183.9 to 426.5
|
435.7 seconds
Interval 331.2 to 540.2
|
377.3 seconds
Interval 122.4 to 632.1
|
|
Jebsen-Taylor Test of Hand Function
Post-test; more affected hand
|
224 seconds
Interval 47.4 to 400.7
|
354.1 seconds
Interval 254.5 to 453.7
|
175.9 seconds
Interval -28.8 to 380.7
|
98.9 seconds
Interval -170.5 to 368.4
|
378.6 seconds
Interval 281.3 to 476.0
|
316.8 seconds
Interval 90.8 to 542.8
|
|
Jebsen-Taylor Test of Hand Function
6 month follow-up; more affected hand
|
266.1 seconds
Interval 109.5 to 422.7
|
342.4 seconds
Interval 233.0 to 451.9
|
213.3 seconds
Interval 13.6 to 413.0
|
146 seconds
Interval -152.0 to 444.0
|
380.2 seconds
Interval 274.2 to 486.2
|
323.8 seconds
Interval 152.0 to 495.5
|
PRIMARY outcome
Timeframe: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)Population: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality
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.
Outcome measures
| Measure |
CIMT; Contralateral CST
n=7 Participants
Constraint Induced Movement Therapy; contralateral corticospinal tract
|
CIMT; Ipsilateral CST
n=26 Participants
Constraint Induced Movement Therapy; ipsilateral corticospinal tract
|
CIMT; Bilateral CST
n=7 Participants
Constraint Induced Movement Therapy; bilateral corticospinal tract
|
HABIT; Contralateral CST
n=3 Participants
Hand Arm Bimanual Intensive Training; contralateral corticospinal tract
|
HABIT; Ipsilateral CST
n=30 Participants
Hand Arm Bimanual Intensive Training; ipsilateral corticospinal tract
|
HABIT; Bilateral CST
n=6 Participants
Hand Arm Bimanual Intensive Training; bilateral corticospinal tract
|
|---|---|---|---|---|---|---|
|
Assisting Hand Assessment
Pre-test
|
55.4 units on a scale
Interval 50.4 to 60.5
|
52.5 units on a scale
Interval 48.5 to 56.6
|
62.3 units on a scale
Interval 57.1 to 67.5
|
61.3 units on a scale
Interval 57.9 to 64.8
|
54.8 units on a scale
Interval 51.4 to 58.1
|
54.5 units on a scale
Interval 48.1 to 60.9
|
|
Assisting Hand Assessment
Post-test
|
58.6 units on a scale
Interval 52.6 to 64.5
|
54 units on a scale
Interval 50.2 to 57.8
|
63.7 units on a scale
Interval 57.6 to 69.8
|
65 units on a scale
Interval 57.9 to 72.1
|
57.2 units on a scale
Interval 54.1 to 60.3
|
56.6 units on a scale
Interval 49.4 to 63.6
|
|
Assisting Hand Assessment
6 month follow-up
|
58.1 units on a scale
Interval 52.4 to 63.9
|
54.4 units on a scale
Interval 50.3 to 58.4
|
64.1 units on a scale
Interval 57.8 to 70.5
|
66.3 units on a scale
Interval 62.9 to 69.8
|
56.5 units on a scale
Interval 53.4 to 59.5
|
56.7 units on a scale
Interval 50.5 to 62.8
|
PRIMARY outcome
Timeframe: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)Population: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality
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.
Outcome measures
| Measure |
CIMT; Contralateral CST
n=7 Participants
Constraint Induced Movement Therapy; contralateral corticospinal tract
|
CIMT; Ipsilateral CST
n=26 Participants
Constraint Induced Movement Therapy; ipsilateral corticospinal tract
|
CIMT; Bilateral CST
n=7 Participants
Constraint Induced Movement Therapy; bilateral corticospinal tract
|
HABIT; Contralateral CST
n=3 Participants
Hand Arm Bimanual Intensive Training; contralateral corticospinal tract
|
HABIT; Ipsilateral CST
n=30 Participants
Hand Arm Bimanual Intensive Training; ipsilateral corticospinal tract
|
HABIT; Bilateral CST
n=6 Participants
Hand Arm Bimanual Intensive Training; bilateral corticospinal tract
|
|---|---|---|---|---|---|---|
|
Box and Blocks Test
Pre-test; more affected hand
|
18.9 blocks moved in 1 minute
Interval 14.7 to 23.1
|
16.6 blocks moved in 1 minute
Interval 12.1 to 21.1
|
21.4 blocks moved in 1 minute
Interval 15.0 to 27.9
|
26 blocks moved in 1 minute
Interval 19.2 to 32.8
|
16.2 blocks moved in 1 minute
Interval 12.5 to 19.9
|
14 blocks moved in 1 minute
Interval 7.9 to 20.1
|
|
Box and Blocks Test
Post-test; more affected hand
|
25.6 blocks moved in 1 minute
Interval 21.0 to 30.1
|
19.2 blocks moved in 1 minute
Interval 13.9 to 24.4
|
27 blocks moved in 1 minute
Interval 20.5 to 33.5
|
27 blocks moved in 1 minute
Interval 20.6 to 33.4
|
19.2 blocks moved in 1 minute
Interval 15.6 to 22.8
|
18.7 blocks moved in 1 minute
Interval 10.0 to 27.4
|
|
Box and Blocks Test
6 month follow-up; more affected hand
|
23.4 blocks moved in 1 minute
Interval 18.7 to 28.0
|
19.7 blocks moved in 1 minute
Interval 14.6 to 24.8
|
24.7 blocks moved in 1 minute
Interval 17.4 to 31.9
|
31.3 blocks moved in 1 minute
Interval 19.7 to 42.9
|
19.3 blocks moved in 1 minute
Interval 15.6 to 23.0
|
18.2 blocks moved in 1 minute
Interval 9.5 to 26.9
|
SECONDARY outcome
Timeframe: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)Population: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality
The COPM is a structured interview in which the individuals are asked to identify up to five functional goals. In this study, parents reported their child's functional goals. Parents rated how well children perform each goal (COPM-Performance), and how satisfied they were with the child's performance (COPM-Satisfaction). The same caregiver was interviewed before and after the intervention. A change of 2 or more points in each scale of COPM is considered a minimum clinically important difference (MCID). The COPM has been validated for parents of children with disabilities. A high score means a better outcome (range 0-10).
Outcome measures
| Measure |
CIMT; Contralateral CST
n=7 Participants
Constraint Induced Movement Therapy; contralateral corticospinal tract
|
CIMT; Ipsilateral CST
n=26 Participants
Constraint Induced Movement Therapy; ipsilateral corticospinal tract
|
CIMT; Bilateral CST
n=7 Participants
Constraint Induced Movement Therapy; bilateral corticospinal tract
|
HABIT; Contralateral CST
n=3 Participants
Hand Arm Bimanual Intensive Training; contralateral corticospinal tract
|
HABIT; Ipsilateral CST
n=30 Participants
Hand Arm Bimanual Intensive Training; ipsilateral corticospinal tract
|
HABIT; Bilateral CST
n=6 Participants
Hand Arm Bimanual Intensive Training; bilateral corticospinal tract
|
|---|---|---|---|---|---|---|
|
Canadian Occupational Performance Measure
Pre-Test; Performance
|
2.5 score on a scale
Interval 1.2 to 3.8
|
2.9 score on a scale
Interval 2.5 to 3.3
|
3.2 score on a scale
Interval 2.5 to 3.9
|
3.5 score on a scale
Interval 3.2 to 3.7
|
2.8 score on a scale
Interval 2.3 to 3.4
|
3.6 score on a scale
Interval 2.9 to 4.2
|
|
Canadian Occupational Performance Measure
Post-Test; Performance
|
4.8 score on a scale
Interval 3.3 to 6.4
|
5.7 score on a scale
Interval 5.0 to 6.4
|
6.3 score on a scale
Interval 5.3 to 7.4
|
5.9 score on a scale
Interval 4.6 to 7.1
|
6.4 score on a scale
Interval 5.8 to 7.0
|
6.5 score on a scale
Interval 5.0 to 8.1
|
|
Canadian Occupational Performance Measure
6 month follow-up; Performance
|
5.3 score on a scale
Interval 4.6 to 6.1
|
6 score on a scale
Interval 5.3 to 6.7
|
6.6 score on a scale
Interval 5.7 to 7.4
|
6.9 score on a scale
Interval 5.5 to 8.4
|
6.1 score on a scale
Interval 5.5 to 6.6
|
6.5 score on a scale
Interval 4.9 to 8.0
|
|
Canadian Occupational Performance Measure
Pre-Test; Satisfaction
|
2.9 score on a scale
Interval 1.9 to 4.0
|
3.2 score on a scale
Interval 2.6 to 3.8
|
3 score on a scale
Interval 1.8 to 4.3
|
4.4 score on a scale
Interval 2.1 to 6.7
|
3.3 score on a scale
Interval 2.6 to 4.0
|
2.7 score on a scale
Interval 2.1 to 3.3
|
|
Canadian Occupational Performance Measure
Post-Test; Satisfaction
|
5.7 score on a scale
Interval 3.8 to 7.7
|
6.4 score on a scale
Interval 5.5 to 7.3
|
7.2 score on a scale
Interval 6.0 to 8.4
|
6.1 score on a scale
Interval 3.7 to 8.5
|
7 score on a scale
Interval 6.4 to 7.7
|
6.8 score on a scale
Interval 5.5 to 8.1
|
|
Canadian Occupational Performance Measure
6 month follow-up; Satisfaction
|
6.3 score on a scale
Interval 5.0 to 7.5
|
6.6 score on a scale
Interval 5.9 to 7.3
|
7.3 score on a scale
Interval 6.5 to 8.2
|
7.7 score on a scale
Interval 5.9 to 9.5
|
6.5 score on a scale
Interval 5.8 to 7.1
|
6.8 score on a scale
Interval 5.5 to 8.1
|
Adverse Events
CIMT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HABIT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CIMT
n=41 participants at risk
Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Constraint-induced Movement Therapy
|
HABIT
n=42 participants at risk
Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab
Hand-arm Bimanual Intensive Therapy
|
|---|---|---|
|
Nervous system disorders
Seizure
|
2.4%
1/41 • 6 months
|
4.8%
2/42 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fall causing broken bone
|
0.00%
0/41 • 6 months
|
4.8%
2/42 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place