- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01643109
Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint (OBI_CIMT)
Childhood Hemiplegic CP Integrated Neuroscience Discovery Network (CP-NET) Theme IIIa: Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary research objective is to evaluate neuroimaging predictors of a positive response to CIMT in children with hemiplegic CP secondary to a middle cerebral artery territory stroke (MCA). A focus on the MCA territory is chosen as (1) it targets children with significant hand impairment who have the potential to benefit from CIMT, (2) is the most common neuropathological subtype, and (3) allows for enhanced homogeneity for the matching of case and comparison groups. The primary research question is: In children aged 7 to 16 years with hemiplegic CP secondary to an MCA stroke, are there neuroimaging predictors of a positive response to CIMT, a positive response being defined by an improvement in the Assisting Hands Assessment (AHA) one month after CIMT?
Neuroimaging predictor variables include laterality index (LI) of the primary M1 and S1 areas on fMRI, IHI evaluated by resting state fMRI, dissociation of the M1 and S1 for the hemiplegic hand measured by fMRI, size and vascular distribution of the MCA lesion with T2 weighted MRI, and white matter tract abnormality with Diffusion Tensor Imaging (DTI). We hypothesize that a negative LI, a non-dissociated M1 and S1, low IHI, small size of infarction, and large size of the contralateral corticospinal tract will predict a positive response to constraint. An evaluation of the neuroimaging predictor variables on the persistence of a positive response to CIMT at 6 months as measured by the AHA will also be explored. A secondary objective will evaluate change in the neuroimaging variables from baseline to one month post CIMT by comparing children in the case group who have received CIMT and a comparison group who are matched on baseline QUEST scores.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8L 8E7
- McMaster Children's Hospital, Hamilton Health Sciences
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London, Ontario, Canada, N6G1G9
- Thames Valley Children's Centre, London Health Sciences Centre
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Toronto, Ontario, Canada, M4G1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Hemiplegic CP secondary to an MCA infarct
- Age between 7 and 16 years
- Ability to co-operate, understand, and follow simple instructions for neuro-imaging outcome measurement: The functional MRI protocol will require some cooperation and the child will need to lie still in a confined place for approximately 45-60 min.
- No previous CIMT within 12-months of study entry or Botulinum toxin upper limb injections within 6-months of study entry.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CIMT
A standardized CIMT protocol will be administered over a three week period.
The first week will consist of wearing a below elbow cast on the non-hemiplegic limb followed by a two week CIMT camp (5 hours per day, 5 days per week) where the child/youth wears a constraint splint on the non-hemiplegic hand.
The two week camp will follow a standardized CIMT camp protocol ("Hand2Hand" developed at HBKRH) that includes activities that focus on unilateral hemiplegic hand activity in the first week and increasing incorporation of bilateral hand activities in the second week.
The camp protocol for CIMT is based on camp protocols utilized successfully in other paediatric research studies.
|
A standardized CIMT protocol will be administered over a three week period.
The first week will consist of wearing a below elbow cast on the non-hemiplegic limb followed by a two week CIMT camp (5 hours per day, 5 days per week) where the child/youth wears a constraint splint on the non-hemiplegic hand.
The two week camp will follow a standardized CIMT camp protocol ("Hand2Hand" developed at HBKRH) that includes activities that focus on unilateral hemiplegic hand activity in the first week and increasing incorporation of bilateral hand activities in the second week.
The camp protocol for CIMT is based on camp protocols utilized successfully in other paediatric research studies.
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No Intervention: Comparison
Standard therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Assisted Hand Assessment
Time Frame: baseline, 1-month after intervention and 6-months
|
The primary outcome measure for this study will be the assisted hand assessment (AHA).
This test is the gold standard in paediatric constraint research to assess the use of the assisting hand in bilateral activities (hand use) in children with hemiplegic CP with established reliability, validity and responsiveness.
Importantly it has undergone the rigour of a Rasch analysis in its development.
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baseline, 1-month after intervention and 6-months
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Collaborators and Investigators
Investigators
- Principal Investigator: Darcy L Fehlings, MD MSc, Holland Bloorview Kids Rehabilitation Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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