Cerebral PalsyNCT02918890

Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia

A study testing Constraint-induced Movement Therapy and Hand-arm Bimanual Intensive Therapy in people with Cerebral Palsy and Hemiplegia, run by Teachers College, Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Cerebral Palsy, Hemiplegia, Children
What is being tested?: Constraint-induced Movement Therapy and Hand-arm Bimanual Intensive Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: Sep 2014to 31 Jan 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of unilateral cerebral palsy

Who cannot join

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

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

Other trials in United States

About this study

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/

Read the 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.

Conditions: Cerebral Palsy, Hemiplegia, Children
Being tested: Constraint-induced Movement Therapy, Hand-arm Bimanual Intensive Therapy
Keywords: Pediatric, HABIT, CIMT, Cerebral Palsy, Hemiplegia, Children, Therapy
Medical subject headings: Cerebral Palsy, Hemiplegia, Habits

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Constraint-induced Movement TherapyOther
Hand-arm Bimanual Intensive TherapyOther

Study groups in NCT02918890
Study group	Role	What they receive
Constraint Induced Movement Therapy	Experimental	Procedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab Receives: Other: Constraint-induced Movement Therapy
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 Receives: Other: Hand-arm Bimanual Intensive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

Secondary outcomes (1)

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).
Measured: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201431 Jan 2019

First posted29 Sep 2016 (estimated)
Study startSep 2014
Primary completionJan 2019
Study completion31 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)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: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02918890
Sponsor's protocol ID: 14-140
Status last verified: Oct 2024
First submitted: 27 Sep 2016
Last updated: 16 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
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 17044964
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.
PubMed 21950396
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.
PubMed 16836774
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.
PubMed 16510616
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.
PubMed 17979861
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.
PubMed 21700924
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.
PubMed 34012418

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
ClinicalTrials.gov ID: NCT02918890
Acronym / sponsor ID: 14-140
Conditions: Cerebral Palsy, Hemiplegia, Children
Keywords: Pediatric, HABIT, CIMT, Cerebral Palsy, Hemiplegia, Children, Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Teachers College, Columbia UniversityUniversity, hospital or other
Collaborators: Burke Medical Research Institute
Study start: Sep 2014
Primary completion: Jan 2019 (actual)
Study completion: 31 Jan 2019 (actual)
First posted: 29 Sep 2016 (estimated)
Results: Posted 16 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Constraint Induced Movement Therapy	Experimental	Other: Constraint-induced Movement TherapyProcedure: Constraint-Induced Movement Therapy 90 hours Other Name: CIT, CI Therapy, restraint therapy, PT, OT, rehab
Hand-Arm Bimanual Intensive Therapy	Experimental	Other: Hand-arm Bimanual Intensive TherapyProcedure: Hand-Arm Bimanual Intensive Therapy (HABIT) 90 hours Other Name: HABIT, bimanual training, bilateral training, restraint therapy, PT, OT, rehab

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Diagnosis of unilateral cerebral palsy

Key exclusion criteria (6 listed)

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

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
Constraint-induced Movement Therapy	Other	Constraint Induced Movement Therapy
Hand-arm Bimanual Intensive Therapy	Other	Hand-Arm Bimanual Intensive Therapy

Primary outcome

Jebsen-Taylor Test of Hand Function
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

Canadian Occupational Performance Measure
Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)

Results and safety

Results posted to the registry on 16 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CIMT	41	41
HABIT	42	41

Primary outcome: Jebsen-Taylor Test of Hand Function

Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up). Mean (95% Confidence Interval). Unit: seconds

Measure	CIMT; Contralateral CST n = 7	CIMT; Ipsilateral CST n = 26	CIMT; Bilateral CST n = 7	HABIT; Contralateral CST n = 3	HABIT; Ipsilateral CST n = 30	HABIT; Bilateral CST n = 6
Pre-test; more affected hand	323.6 (89.9 to 557.3)	479.5 (358.5 to 600.5)	265.6 (46.6 to 484.6)	121.3 (-183.9 to 426.5)	435.7 (331.2 to 540.2)	377.3 (122.4 to 632.1)
Post-test; more affected hand	224 (47.4 to 400.7)	354.1 (254.5 to 453.7)	175.9 (-28.8 to 380.7)	98.9 (-170.5 to 368.4)	378.6 (281.3 to 476)	316.8 (90.8 to 542.8)
6 month follow-up; more affected hand	266.1 (109.5 to 422.7)	342.4 (233 to 451.9)	213.3 (13.6 to 413)	146 (-152 to 444)	380.2 (274.2 to 486.2)	323.8 (152 to 495.5)

Population analysed: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality

Primary outcome: Assisting Hand Assessment

Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up). Mean (95% Confidence Interval). Unit: units on a scale

Measure	CIMT; Contralateral CST n = 7	CIMT; Ipsilateral CST n = 26	CIMT; Bilateral CST n = 7	HABIT; Contralateral CST n = 3	HABIT; Ipsilateral CST n = 30	HABIT; Bilateral CST n = 6
Pre-test	55.4 (50.4 to 60.5)	52.5 (48.5 to 56.6)	62.3 (57.1 to 67.5)	61.3 (57.9 to 64.8)	54.8 (51.4 to 58.1)	54.5 (48.1 to 60.9)
Post-test	58.6 (52.6 to 64.5)	54 (50.2 to 57.8)	63.7 (57.6 to 69.8)	65 (57.9 to 72.1)	57.2 (54.1 to 60.3)	56.6 (49.4 to 63.6)
6 month follow-up	58.1 (52.4 to 63.9)	54.4 (50.3 to 58.4)	64.1 (57.8 to 70.5)	66.3 (62.9 to 69.8)	56.5 (53.4 to 59.5)	56.7 (50.5 to 62.8)

Population analysed: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality

Primary outcome: Box and Blocks Test

Time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up). Mean (95% Confidence Interval). Unit: blocks moved in 1 minute

Measure	CIMT; Contralateral CST n = 7	CIMT; Ipsilateral CST n = 26	CIMT; Bilateral CST n = 7	HABIT; Contralateral CST n = 3	HABIT; Ipsilateral CST n = 30	HABIT; Bilateral CST n = 6
Pre-test; more affected hand	18.9 (14.7 to 23.1)	16.6 (12.1 to 21.1)	21.4 (15 to 27.9)	26 (19.2 to 32.8)	16.2 (12.5 to 19.9)	14 (7.9 to 20.1)
Post-test; more affected hand	25.6 (21 to 30.1)	19.2 (13.9 to 24.4)	27 (20.5 to 33.5)	27 (20.6 to 33.4)	19.2 (15.6 to 22.8)	18.7 (10 to 27.4)
6 month follow-up; more affected hand	23.4 (18.7 to 28)	19.7 (14.6 to 24.8)	24.7 (17.4 to 31.9)	31.3 (19.7 to 42.9)	19.3 (15.6 to 23)	18.2 (9.5 to 26.9)

Population analysed: 1 participant (CIMT) and 2 participants (HABIT) were excluded from analysis due to inability to determine corticospinal tract laterality

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CIMT	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41
HABIT	0 of 42 (0%)	4 of 42 (9.5%)	0 of 42

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Background: PubMed 21950396Gordon 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.
Results publication: PubMed 16836774Charles 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.
Results publication: PubMed 16510616Gordon 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.
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.
Results publication: PubMed 21700924Gordon 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.
Results publication: PubMed 34012418Friel 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.

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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. principal investigator

Teachers College, Columbia University

Kathleen Friel, Ph.D. principal investigator

Burke Neurological Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 6 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 16 Dec 2024. 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?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Jebsen-Taylor Test of Hand Function (time frame: Baseline (pre-test), within 2 days after treatment (post-test), 6 months after treatment (follow-up)). The study lists 3 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 NCT02918890, which also lists 7 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 16 Dec 2024.