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Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint (OBI_CIMT)

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Casting & CIMT
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Cerebral Palsy, Hemiplegia, Constraint Induced Movement Therapy

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster Children's Hospital, Hamilton Health Sciences
  • Thames Valley Children's Centre, London Health Sciences Centre
  • Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CIMT

Comparison

Arm Description

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.

Standard therapy.

Outcomes

Primary Outcome Measures

Change from baseline in Assisted Hand Assessment
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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2012
Last Updated
January 11, 2016
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01643109
Brief Title
Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint
Acronym
OBI_CIMT
Official Title
Childhood Hemiplegic CP Integrated Neuroscience Discovery Network (CP-NET) Theme IIIa: Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
CIMT has shown great promise in helping children and adults regain lost function in a disabled limb by forcing its use through an intensive motor training program and constraining the unaffected arm with a cast. However, relatively little is known about the underlying mechanisms of CIMT in hemiplegic CP. This project will use an integrated translation model to explore neuroimaging predictors of a positive clinical response to CIMT.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Cerebral Palsy, Hemiplegia, Constraint Induced Movement Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIMT
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Standard therapy.
Intervention Type
Other
Intervention Name(s)
Casting & CIMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Assisted Hand Assessment
Description
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.
Time Frame
baseline, 1-month after intervention and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcy L Fehlings, MD MSc
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital, Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Facility Name
Thames Valley Children's Centre, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G1G9
Country
Canada
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G1R8
Country
Canada

12. IPD Sharing Statement

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Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint

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