Cerebral Palsy, Hemiplegia, Children
Conditions
Keywords
Pediatric, HABIT, CIMT, Cerebral Palsy, Hemiplegia, Children, Therapy
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/
Detailed description
Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches to engage children in fun activities. This study looks at what areas of the brain are responsible for recovery after intensive training. We are trying to understand how the brain responds to movement training and hope that in the future we can develop new treatments for hemiplegia based on what we learn about the brain in this study. To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS will be used in this study, which is considered minimal risk and tolerable to children. If your child has a recurrent history of seizures after two years of age, he/she might not qualify.
Interventions
OTHERHand-arm Bimanual Intensive Therapy
Sponsors
Burke Medical Research Institute
Teachers College, Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of unilateral cerebral palsy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jebsen-Taylor Test of Hand Function | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) | 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. |
| Assisting Hand Assessment | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) | 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. |
| Box and Blocks Test | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CIMT Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Constraint-induced Movement Therapy | 40 |
| 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 | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | CIMT | Total | HABIT |
|---|---|---|---|
| Age, Continuous | 9.33 years STANDARD_DEVIATION 2.83 | 9.46 years STANDARD_DEVIATION 3.12 | 9.58 years STANDARD_DEVIATION 3.42 |
| Assisting Hand Assessment | 56.7 logits STANDARD_DEVIATION 20.7 | 56.0 logits STANDARD_DEVIATION 15.83 | 55.2 logits STANDARD_DEVIATION 8.7 |
| Box and Blocks Test | 18.2 blocks STANDARD_DEVIATION 10.1 | 17.4 blocks STANDARD_DEVIATION 9.94 | 16.6 blocks STANDARD_DEVIATION 9.8 |
| Canadian Occupational Performance Measure - Performance | 2.9 units on a scale STANDARD_DEVIATION 1.1 | 2.95 units on a scale STANDARD_DEVIATION 1.07 | 3.0 units on a scale STANDARD_DEVIATION 1.4 |
| Canadian Occupational Performance Measure - Satisfaction | 3.1 units on a scale STANDARD_DEVIATION 1.6 | 3.2 units on a scale STANDARD_DEVIATION 1.7 | 3.3 units on a scale STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 74 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Jebsen-Taylor Test of Hand Function | 405.1 seconds STANDARD_DEVIATION 306.8 | 403.8 seconds STANDARD_DEVIATION 299.85 | 402.5 seconds STANDARD_DEVIATION 296.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 56 Participants | 30 Participants |
| Sex: Female, Male Female | 13 Participants | 31 Participants | 18 Participants |
| Sex: Female, Male Male | 27 Participants | 48 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 1 / 41 | 4 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 |
Outcome results
Primary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CIMT; Contralateral CST | Assisting Hand Assessment | Post-test | 58.6 units on a scale |
| CIMT; Contralateral CST | Assisting Hand Assessment | Pre-test | 55.4 units on a scale |
| CIMT; Contralateral CST | Assisting Hand Assessment | 6 month follow-up | 58.1 units on a scale |
| CIMT; Ipsilateral CST | Assisting Hand Assessment | Post-test | 54 units on a scale |
| CIMT; Ipsilateral CST | Assisting Hand Assessment | Pre-test | 52.5 units on a scale |
| CIMT; Ipsilateral CST | Assisting Hand Assessment | 6 month follow-up | 54.4 units on a scale |
| CIMT; Bilateral CST | Assisting Hand Assessment | Post-test | 63.7 units on a scale |
| CIMT; Bilateral CST | Assisting Hand Assessment | Pre-test | 62.3 units on a scale |
| CIMT; Bilateral CST | Assisting Hand Assessment | 6 month follow-up | 64.1 units on a scale |
| HABIT; Contralateral CST | Assisting Hand Assessment | Post-test | 65 units on a scale |
| HABIT; Contralateral CST | Assisting Hand Assessment | Pre-test | 61.3 units on a scale |
| HABIT; Contralateral CST | Assisting Hand Assessment | 6 month follow-up | 66.3 units on a scale |
| HABIT; Ipsilateral CST | Assisting Hand Assessment | Post-test | 57.2 units on a scale |
| HABIT; Ipsilateral CST | Assisting Hand Assessment | Pre-test | 54.8 units on a scale |
| HABIT; Ipsilateral CST | Assisting Hand Assessment | 6 month follow-up | 56.5 units on a scale |
| HABIT; Bilateral CST | Assisting Hand Assessment | Pre-test | 54.5 units on a scale |
| HABIT; Bilateral CST | Assisting Hand Assessment | 6 month follow-up | 56.7 units on a scale |
| HABIT; Bilateral CST | Assisting Hand Assessment | Post-test | 56.6 units on a scale |
Primary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CIMT; Contralateral CST | Box and Blocks Test | Post-test; more affected hand | 25.6 blocks moved in 1 minute |
| CIMT; Contralateral CST | Box and Blocks Test | Pre-test; more affected hand | 18.9 blocks moved in 1 minute |
| CIMT; Contralateral CST | Box and Blocks Test | 6 month follow-up; more affected hand | 23.4 blocks moved in 1 minute |
| CIMT; Ipsilateral CST | Box and Blocks Test | Post-test; more affected hand | 19.2 blocks moved in 1 minute |
| CIMT; Ipsilateral CST | Box and Blocks Test | Pre-test; more affected hand | 16.6 blocks moved in 1 minute |
| CIMT; Ipsilateral CST | Box and Blocks Test | 6 month follow-up; more affected hand | 19.7 blocks moved in 1 minute |
| CIMT; Bilateral CST | Box and Blocks Test | Post-test; more affected hand | 27 blocks moved in 1 minute |
| CIMT; Bilateral CST | Box and Blocks Test | Pre-test; more affected hand | 21.4 blocks moved in 1 minute |
| CIMT; Bilateral CST | Box and Blocks Test | 6 month follow-up; more affected hand | 24.7 blocks moved in 1 minute |
| HABIT; Contralateral CST | Box and Blocks Test | Post-test; more affected hand | 27 blocks moved in 1 minute |
| HABIT; Contralateral CST | Box and Blocks Test | Pre-test; more affected hand | 26 blocks moved in 1 minute |
| HABIT; Contralateral CST | Box and Blocks Test | 6 month follow-up; more affected hand | 31.3 blocks moved in 1 minute |
| HABIT; Ipsilateral CST | Box and Blocks Test | Post-test; more affected hand | 19.2 blocks moved in 1 minute |
| HABIT; Ipsilateral CST | Box and Blocks Test | Pre-test; more affected hand | 16.2 blocks moved in 1 minute |
| HABIT; Ipsilateral CST | Box and Blocks Test | 6 month follow-up; more affected hand | 19.3 blocks moved in 1 minute |
| HABIT; Bilateral CST | Box and Blocks Test | Pre-test; more affected hand | 14 blocks moved in 1 minute |
| HABIT; Bilateral CST | Box and Blocks Test | 6 month follow-up; more affected hand | 18.2 blocks moved in 1 minute |
| HABIT; Bilateral CST | Box and Blocks Test | Post-test; more affected hand | 18.7 blocks moved in 1 minute |
Primary
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CIMT; Contralateral CST | Jebsen-Taylor Test of Hand Function | Post-test; more affected hand | 224 seconds |
| CIMT; Contralateral CST | Jebsen-Taylor Test of Hand Function | Pre-test; more affected hand | 323.6 seconds |
| CIMT; Contralateral CST | Jebsen-Taylor Test of Hand Function | 6 month follow-up; more affected hand | 266.1 seconds |
| CIMT; Ipsilateral CST | Jebsen-Taylor Test of Hand Function | Post-test; more affected hand | 354.1 seconds |
| CIMT; Ipsilateral CST | Jebsen-Taylor Test of Hand Function | Pre-test; more affected hand | 479.5 seconds |
| CIMT; Ipsilateral CST | Jebsen-Taylor Test of Hand Function | 6 month follow-up; more affected hand | 342.4 seconds |
| CIMT; Bilateral CST | Jebsen-Taylor Test of Hand Function | Post-test; more affected hand | 175.9 seconds |
| CIMT; Bilateral CST | Jebsen-Taylor Test of Hand Function | Pre-test; more affected hand | 265.6 seconds |
| CIMT; Bilateral CST | Jebsen-Taylor Test of Hand Function | 6 month follow-up; more affected hand | 213.3 seconds |
| HABIT; Contralateral CST | Jebsen-Taylor Test of Hand Function | Post-test; more affected hand | 98.9 seconds |
| HABIT; Contralateral CST | Jebsen-Taylor Test of Hand Function | Pre-test; more affected hand | 121.3 seconds |
| HABIT; Contralateral CST | Jebsen-Taylor Test of Hand Function | 6 month follow-up; more affected hand | 146 seconds |
| HABIT; Ipsilateral CST | Jebsen-Taylor Test of Hand Function | Post-test; more affected hand | 378.6 seconds |
| HABIT; Ipsilateral CST | Jebsen-Taylor Test of Hand Function | Pre-test; more affected hand | 435.7 seconds |
| HABIT; Ipsilateral CST | Jebsen-Taylor Test of Hand Function | 6 month follow-up; more affected hand | 380.2 seconds |
| HABIT; Bilateral CST | Jebsen-Taylor Test of Hand Function | Pre-test; more affected hand | 377.3 seconds |
| HABIT; Bilateral CST | Jebsen-Taylor Test of Hand Function | 6 month follow-up; more affected hand | 323.8 seconds |
| HABIT; Bilateral CST | Jebsen-Taylor Test of Hand Function | Post-test; more affected hand | 316.8 seconds |
Secondary
Canadian Occupational Performance Measure
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).
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CIMT; Contralateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Performance | 5.3 score on a scale |
| CIMT; Contralateral CST | Canadian Occupational Performance Measure | Pre-Test; Satisfaction | 2.9 score on a scale |
| CIMT; Contralateral CST | Canadian Occupational Performance Measure | Post-Test; Performance | 4.8 score on a scale |
| CIMT; Contralateral CST | Canadian Occupational Performance Measure | Pre-Test; Performance | 2.5 score on a scale |
| CIMT; Contralateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Satisfaction | 6.3 score on a scale |
| CIMT; Contralateral CST | Canadian Occupational Performance Measure | Post-Test; Satisfaction | 5.7 score on a scale |
| CIMT; Ipsilateral CST | Canadian Occupational Performance Measure | Post-Test; Satisfaction | 6.4 score on a scale |
| CIMT; Ipsilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Performance | 6 score on a scale |
| CIMT; Ipsilateral CST | Canadian Occupational Performance Measure | Pre-Test; Satisfaction | 3.2 score on a scale |
| CIMT; Ipsilateral CST | Canadian Occupational Performance Measure | Post-Test; Performance | 5.7 score on a scale |
| CIMT; Ipsilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Satisfaction | 6.6 score on a scale |
| CIMT; Ipsilateral CST | Canadian Occupational Performance Measure | Pre-Test; Performance | 2.9 score on a scale |
| CIMT; Bilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Satisfaction | 7.3 score on a scale |
| CIMT; Bilateral CST | Canadian Occupational Performance Measure | Post-Test; Satisfaction | 7.2 score on a scale |
| CIMT; Bilateral CST | Canadian Occupational Performance Measure | Pre-Test; Satisfaction | 3 score on a scale |
| CIMT; Bilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Performance | 6.6 score on a scale |
| CIMT; Bilateral CST | Canadian Occupational Performance Measure | Pre-Test; Performance | 3.2 score on a scale |
| CIMT; Bilateral CST | Canadian Occupational Performance Measure | Post-Test; Performance | 6.3 score on a scale |
| HABIT; Contralateral CST | Canadian Occupational Performance Measure | Pre-Test; Performance | 3.5 score on a scale |
| HABIT; Contralateral CST | Canadian Occupational Performance Measure | Pre-Test; Satisfaction | 4.4 score on a scale |
| HABIT; Contralateral CST | Canadian Occupational Performance Measure | Post-Test; Satisfaction | 6.1 score on a scale |
| HABIT; Contralateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Satisfaction | 7.7 score on a scale |
| HABIT; Contralateral CST | Canadian Occupational Performance Measure | Post-Test; Performance | 5.9 score on a scale |
| HABIT; Contralateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Performance | 6.9 score on a scale |
| HABIT; Ipsilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Satisfaction | 6.5 score on a scale |
| HABIT; Ipsilateral CST | Canadian Occupational Performance Measure | Pre-Test; Performance | 2.8 score on a scale |
| HABIT; Ipsilateral CST | Canadian Occupational Performance Measure | Pre-Test; Satisfaction | 3.3 score on a scale |
| HABIT; Ipsilateral CST | Canadian Occupational Performance Measure | Post-Test; Satisfaction | 7 score on a scale |
| HABIT; Ipsilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Performance | 6.1 score on a scale |
| HABIT; Ipsilateral CST | Canadian Occupational Performance Measure | Post-Test; Performance | 6.4 score on a scale |
| HABIT; Bilateral CST | Canadian Occupational Performance Measure | Post-Test; Performance | 6.5 score on a scale |
| HABIT; Bilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Satisfaction | 6.8 score on a scale |
| HABIT; Bilateral CST | Canadian Occupational Performance Measure | 6 month follow-up; Performance | 6.5 score on a scale |
| HABIT; Bilateral CST | Canadian Occupational Performance Measure | Pre-Test; Performance | 3.6 score on a scale |
| HABIT; Bilateral CST | Canadian Occupational Performance Measure | Pre-Test; Satisfaction | 2.7 score on a scale |
| HABIT; Bilateral CST | Canadian Occupational Performance Measure | Post-Test; Satisfaction | 6.8 score on a scale |