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| Name | Class |
|---|---|
| Burke Medical Research Institute | OTHER |
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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/
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Constraint Induced Movement Therapy | Experimental | Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab |
|
| Hand-Arm Bimanual Intensive Therapy | Experimental | Procedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constraint-induced Movement Therapy | Other |
| ||
| Hand-arm Bimanual Intensive Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Gordon, Ph.D. | Teachers College, Columbia University | Principal Investigator |
| Kathleen Friel, Ph.D. | Burke Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teachers College, Columbia University Center for Cerebral Palsy Research | New York | New York | 10027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17044964 | Background | 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. | |
| 21950396 | Background | Gordon 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CIMT | Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab Constraint-induced Movement Therapy |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality
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| ID | Title | Description |
|---|---|---|
| BG000 | CIMT | Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab Constraint-induced Movement Therapy |
| BG001 | HABIT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality | Posted | Mean | 95% Confidence Interval | seconds | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CIMT | Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab Constraint-induced Movement Therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew M. Gordon | Columbia University | 212.678.3332 | ag275@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2014 | Oct 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| D006184 | Habits |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000098483 | Constraint Induced Movement Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Other |
|
| Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) |
| 16836774 | Result | Charles 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. |
| 16510616 | Result | Gordon 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. |
| 17979861 | Result | Gordon 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. |
| 21700924 | Result | Gordon 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. |
| 34012418 | Result | Friel 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. |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 to complete all tasks. The test was performed on both the more affected and less affected hands. The JTTHF is well-validated and has excellent reliability. | Mean | Standard Deviation | seconds |
|
| Assisting Hand Assessment | The AHA is a validated test for measuring bimanual hand use in children with upper extremity 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. The smallest detectable difference (SDD) for AHA is an improvement of at least 5 units. | Mean | Standard Deviation | logits |
|
| 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 one minute. Both hands were tested. The BBT is valid and reliable for children with CP. | Mean | Standard Deviation | blocks |
|
| Canadian Occupational Performance Measure - Performance | 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. | Mean | Standard Deviation | units on a scale |
|
| Canadian Occupational Performance Measure - Satisfaction | 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. | Mean | Standard Deviation | units on a scale |
|
Constraint Induced Movement Therapy; ipsilateral corticospinal tract |
| OG002 | CIMT; Bilateral CST | Constraint Induced Movement Therapy; bilateral corticospinal tract |
| OG003 | HABIT; Contralateral CST | Hand Arm Bimanual Intensive Training; contralateral corticospinal tract |
| OG004 | HABIT; Ipsilateral CST | Hand Arm Bimanual Intensive Training; ipsilateral corticospinal tract |
| OG005 | HABIT; Bilateral CST | Hand Arm Bimanual Intensive Training; bilateral corticospinal tract |
|
|
| 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. | 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) |
|
|
|
| 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. | 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality | Posted | Mean | 95% Confidence Interval | blocks moved in 1 minute | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) |
|
|
|
| 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). | 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up) |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 1 |
| 41 |
| EG001 | 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 | 0 | 42 | 0 | 42 | 4 | 42 |
| Fall causing broken bone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Post-test |
|
| 6 month follow-up |
|
| Post-test; more affected hand |
|
| 6 month follow-up; more affected hand |
|
| Post-Test; Performance |
|
| 6 month follow-up; Performance |
|
| Pre-Test; Satisfaction |
|
| Post-Test; Satisfaction |
|
| 6 month follow-up; Satisfaction |
|