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

NCT01643109 | Completed DMC

• 1 other identifier: 12-294
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Cerebral Palsy; Hemiplegia; Constraint Induced Movement Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 1-month after intervention and 6-months

Study Arms (2)

CIMT

EXPERIMENTAL

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

Comparison

NO INTERVENTION

Standard therapy.

Interventions

Casting & CIMT OTHER

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.

CIMT

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (3)

McMaster Children's Hospital, Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Location

Thames Valley Children's Centre, London Health Sciences Centre

London, Ontario, N6G1G9, Canada

Location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darcy L Fehlings, MD MSc

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 17, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

CA (3)