Cerebral PalsyNCT02299284
Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
A study testing Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia in people with Cerebral Palsy, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
A randomized control trial to test the efficacy of a new treatment involving intensive home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive home-based functional lower-limb training in children with hemiplegia. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 2.5 - 12 years with hemiplegia; hemiplegia due to result of prenatal stroke, brain lesion, or malformation (or within the two years of life).
- Children that have the ability to grasp or release objects with the affected hand
- Children who are able to walk independently without the assistance of a device
- Children that have the cognitive capability to follow simple instructions and interact in play activities 2 hours per day with a parent/caregiver.
- Caregivers willing to commit to the entire intervention period of 90 hours over 9 weeks
- Caregivers able to provide one-on-one attention to child during the daily two hours of activities (note: because this is part of a research study, we can only train one caregiver per household)
Who cannot join
- Children that have received Botox or are planning any new treatment within 6 mos. of enrollment in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Teachers College, Columbia University Center for Cerebral Palsy Research
New York, New York, 10027
About this study
A randomized control trial to test the efficacy of a new treatment involving intensive home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive home-based functional lower-limb training in children with hemiplegia. The protocols have been developed at TC Columbia University to be child friendly and draw upon the investigators experience since 1998 with intensive movement therapy in children with cerebral palsy. The aim is to promote either the use/coordination of movement of the hands or improve lower-limb balance, strength, and function. Caregivers will be trained at the investigator center and then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of activities with their child in their own home. The activities will be supervised by the investigators team via computer. Participants do NOT need to live in the New York City area, but a one-time weekend visit to the investigators center is required for training. All measurement and treatment is performed in the home.
Participants are randomized to receive either HABIT or lower-limb training. If caregivers wish, they may chose to be crossed over at the end of the study and trained to receive the other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more information: http://www.tc.edu/centers/cit/
Read the detailed description
The investigators are currently recruiting children with hemiplegia between the ages of 2.5 to 12 years of age to participate in a study examining the effects of extensive practice on affected hand/arm use and lower- limb use. This is a research study that will teach caregivers how to administer either hand-arm bimanual intensive training (HABIT) or lower-limb intensive training in their own home. HABIT aims to improve the use and coordination of both arms in daily function, particularly during the performance of bimanual activities (i.e. buttoning a shirt, cutting with scissors). Lower-limb intensive training aims to improve the quality of lower-limb functioning with a particular focus on functional activities (i.e. getting up from a chair, walking, climbing stairs).
What does participation entail?
- Being randomized to learn to provide either intensive lower- or upper-limb activities in your own home (training will be provided over a a weekend session at our center)
- Getting trained to administer some basic upper- and lower-limb assessments in your own home
- Completing 90 hours of activities over a period of 9 weeks (2 hrs/day, 5 days/week; does not have to be 2 consecutive hours for daily activities)
- Videoconferencing online with a project supervisor at least 1 hour per week during activities
- Learning how to assess your child's motor function for posttesting.
Can I choose to receive upper or lower extremity training if my child qualifies?
- Unfortunately not, it must be randomly assigned as each group will be compared to the other. However, the investigators can provide training tips after completion of the study.
What if my child does not qualify?
- There may be opportunities at a later date or for another study.
- Please contact us at (212)-678-3332 or cpresearch@tc.columbia.edu if you have any questions.
- Conditions
- Cerebral Palsy
- Being tested
- Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
- Keywords
- Spastic, Hemiplegia
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Home-based Bimanual and Lower-limb Training in Young Children With HemiplegiaOther
| Study group | Role | What they receive |
|---|---|---|
| Hand-Arm Bimanual Intensive Therapy (HABIT) | Experimental | HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab Receives: Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia |
| Intensive Functional Lower-Limb Training | Experimental | lower-limb function, strength training, balance, PT, OT, rehab Receives: Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment
measure of bimanual hand-use in spontaneous play setting
Measured: Change from baseline to 9 weeks
10 Meter walk test
measures child's velocity when walking over 10 meters
Measured: Change from baseline to 9 weeks
Secondary outcomes (2)
Assisting Hand Assessment
measure of bimanual hand-use in spontaneous play setting
Measured: Change from baseline to 6 months
10 Meter walk test
measures child's velocity when walking over 10 meters
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Gordon, Ph.D., Study director, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299284
- Sponsor's protocol ID
- 13-219CR
- Status last verified
- May 2017
- First submitted
- 12 Nov 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17044964Ferre CL, Brandao MB, Hung YC, Carmel JB, Gordon AM. Feasibility of caregiver-directed home-based hand-arm bimanual intensive training: a brief report. Dev Neurorehabil. 2015 Feb;18(1):69-74. doi: 10.3109/17518423.2014.948641. Epub 2014 Sep 2.
PubMed 25180530Gordon 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.
PubMed 17979861Surana BK, Ferre CL, Dew AP, Brandao M, Gordon AM, Moreau NG. Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Oct;33(10):862-872. doi: 10.1177/1545968319868719. Epub 2019 Aug 22.
PubMed 31434537
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT02299284
- Acronym / sponsor ID
- 13-219CR
- Conditions
- Cerebral Palsy
- Keywords
- Spastic, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized control trial to test the efficacy of a new treatment involving intensive home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive home-based functional lower-limb training in children with hemiplegia. The protocols have been developed at TC Columbia University to be child friendly and draw upon the investigators experience since 1998 with intensive movement therapy in children with cerebral palsy. The aim is to promote either the use/coordination of movement of the hands or improve lower-limb balance, strength, and function. Caregivers will be trained at the investigator center and then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of activities with their child in their own home. The activities will be supervised by the investigators team via computer. Participants do NOT need to live in the New York City area, but a one-time weekend visit to the investigators center is required for training. All measurement and treatment is performed in the home.
Participants are randomized to receive either HABIT or lower-limb training. If caregivers wish, they may chose to be crossed over at the end of the study and trained to receive the other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more information: http://www.tc.edu/centers/cit/
Detailed description
The investigators are currently recruiting children with hemiplegia between the ages of 2.5 to 12 years of age to participate in a study examining the effects of extensive practice on affected hand/arm use and lower- limb use. This is a research study that will teach caregivers how to administer either hand-arm bimanual intensive training (HABIT) or lower-limb intensive training in their own home. HABIT aims to improve the use and coordination of both arms in daily function, particularly during the performance of bimanual activities (i.e. buttoning a shirt, cutting with scissors). Lower-limb intensive training aims to improve the quality of lower-limb functioning with a particular focus on functional activities (i.e. getting up from a chair, walking, climbing stairs).
What does participation entail?
- Being randomized to learn to provide either intensive lower- or upper-limb activities in your own home (training will be provided over a a weekend session at our center)
- Getting trained to administer some basic upper- and lower-limb assessments in your own home
- Completing 90 hours of activities over a period of 9 weeks (2 hrs/day, 5 days/week; does not have to be 2 consecutive hours for daily activities)
- Videoconferencing online with a project supervisor at least 1 hour per week during activities
- Learning how to assess your child's motor function for posttesting.
Can I choose to receive upper or lower extremity training if my child qualifies?
- Unfortunately not, it must be randomly assigned as each group will be compared to the other. However, the investigators can provide training tips after completion of the study.
What if my child does not qualify?
- There may be opportunities at a later date or for another study.
- Please contact us at (212)-678-3332 or cpresearch@tc.columbia.edu if you have any questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand-Arm Bimanual Intensive Therapy (HABIT) | Experimental | Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With HemiplegiaHABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab |
| Intensive Functional Lower-Limb Training | Experimental | Other: Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegialower-limb function, strength training, balance, PT, OT, rehab |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between the ages of 2.5 - 12 years with hemiplegia; hemiplegia due to result of prenatal stroke, brain lesion, or malformation (or within the two years of life).
- Children that have the ability to grasp or release objects with the affected hand
- Children who are able to walk independently without the assistance of a device
- Children that have the cognitive capability to follow simple instructions and interact in play activities 2 hours per day with a parent/caregiver.
- Caregivers willing to commit to the entire intervention period of 90 hours over 9 weeks
Key exclusion criteria (1 listed)
- Children that have received Botox or are planning any new treatment within 6 mos. of enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia | Other | Hand-Arm Bimanual Intensive Therapy (HABIT), Intensive Functional Lower-Limb Training |
Primary outcome
Assisting Hand Assessment
Time frame: Change from baseline to 9 weeks
measure of bimanual hand-use in spontaneous play setting
10 Meter walk test
Time frame: Change from baseline to 9 weeks
measures child's velocity when walking over 10 meters
2 secondary outcomes
Assisting Hand Assessment
Time frame: Change from baseline to 6 months
10 Meter walk test
Time frame: Change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 17044964Charles 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.
- Results publication: PubMed 25180530Ferre CL, Brandao MB, Hung YC, Carmel JB, Gordon AM. Feasibility of caregiver-directed home-based hand-arm bimanual intensive training: a brief report. Dev Neurorehabil. 2015 Feb;18(1):69-74. doi: 10.3109/17518423.2014.948641. Epub 2014 Sep 2.
- Results publication: PubMed 17979861Gordon 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.
- Derived from this study: PubMed 31434537Surana BK, Ferre CL, Dew AP, Brandao M, Gordon AM, Moreau NG. Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Oct;33(10):862-872. doi: 10.1177/1545968319868719. Epub 2019 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Gordon, Ph.D. study director
Teachers College, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia in people with Cerebral Palsy, run by Teachers College, Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting Hand Assessment (time frame: Change from baseline to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299284, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.