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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01643109
First received: July 12, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Hemiplegic Cerebral Palsy
Other: Casting & CIMT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Holland Bloorview Kids Rehabilitation Hospital:

Primary Outcome Measures:
  • Change from baseline in Assisted Hand Assessment [ Time Frame: baseline, 1-month after intervention and 6-months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Casting & 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.
No Intervention: Comparison
Standard therapy.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643109

Locations
Canada, Ontario
McMaster Children's Hospital, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 8E7
Thames Valley Children's Centre, London Health Sciences Centre
London, Ontario, Canada, N6G1G9
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G1R8
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
Principal Investigator: Darcy L Fehlings, MD MSc Holland Bloorview Kids Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01643109     History of Changes
Other Study ID Numbers: 12-294
Study First Received: July 12, 2012
Last Updated: September 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Cerebral Palsy
Hemiplegia
Constraint Induced Movement Therapy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014