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Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke

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ClinicalTrials.gov Identifier: NCT03672864
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Brain Canada
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
A prospective, single blind, parallel group, randomized control trial to determine if early, intensive leg exercise delivered by a physical therapist and a parent in combination improves gross motor function more than standard of care.

Condition or disease Intervention/treatment Phase
Perinatal Stroke Behavioral: Intensive exercise Not Applicable

Detailed Description:

A prospective, randomized controlled trial at 3 healthcare centres: Edmonton, Calgary and Ottawa. The period of participation for each child is 12 months. The Immediate Group will have 3 months of intervention and 9 months follow-up. The Delay Group will be followed for 6 months (control period), then given the opportunity to receive the same intervention and followed for 3 months after the intervention.

The intervention will be delivered by clinicians in the rehabilitation centres in partnership with the child's parents. Therapists will provide training 2 days a week and will coach the parents to provide the training at home for 2 days a week.

The intervention will consist of child-initiated, intensive leg activities for one hour a day, four days a week for 12 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Assessing therapists are blinded to the child's group assignment.
Primary Purpose: Treatment
Official Title: Parent Therapist Partnership to Provide Early, Intensive Exercise to Enhance Walking Outcomes in Children With Perinatal Stroke
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Group
The intervention is intensive exercise, delivered over 12 weeks beginning on admission to the study. The group will then be followed for 9 months post intervention.
Behavioral: Intensive exercise
Intensive, child-initiated movement of the lower extremity: 1 hour/day, 4 days/week, 2 sessions delivered by a physical therapist, 2 delivered by a parent. All activities are play based, and exercise intensity is enhanced by small weights placed on the dorsum of the foot and the ankle of the affected limb. Intervention is delivered over 12 weeks for a target of 48 hours of training.

No Intervention: Delay Group
The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention.



Primary Outcome Measures :
  1. Change in Gross Motor Function Measure (GMFM-66) from baseline [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    A 66 item criterion referenced observational measure of gross motor skills designed for children with cerebral palsy.


Secondary Outcome Measures :
  1. Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) from baseline [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    A questionnaire format completed by parents including 5 scales: 1) daily activities, 2) movement and balance, 3) pain and hurt, 4) fatigue, and 5) eating activities.

  2. Change in stiffness at the ankle [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    We will use a newly developed device for measuring spasticity, called Portable Spasticity Assessment Device (PSAD). A hand-held segment of the device is applied to a limb segment to measure the forces applied by the hand to the limb and the motion of the limb. Disposable, surface electromyographic electrodes are applied to the skin of the limb to measure the muscle activity. In this way, the reflex contractions and the stiffness of the limb can be measured simultaneously. The data is recorded in real time on a laptop computer and saved for further analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 8 months - 2 years old
  • MRI evidence of unilateral, ischemic perinatal stroke
  • Signs of hemiparesis in the arm, leg or both
  • Parental agreement to adhere to the training and testing schedule

Exclusion Criteria:

  • Clinical signs of bilateral involvement
  • Unstable epileptic seizures
  • Cognitive, behavioural or development impairments that preclude participation in the protocol
  • Botulinum toxin injections or surgery in the legs over the last 6 months
  • Concurrent Constraint Induced Movement Therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672864


Contacts
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Contact: Donna Livingstone 780-492-4858 carre@ualberta.ca
Contact: Jaynie Yang 780-492-2894 jaynie@ualberta.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Donna Livingstone, BScPT    780-492-4858    carre@ualberta.ca   
Principal Investigator: Elizabeth Condliffe, MD, Phd         
Glenrose Rehabilitation Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Donna Livingstone    780-492-4858    carre@ualberta.ca   
Canada, Ontario
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada
Contact: Donna Livingstone, BScPT    780-492-4858    carre@ualberta.ca   
Principal Investigator: Anna McCormick, MD         
Sponsors and Collaborators
University of Alberta
Brain Canada
Investigators
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Principal Investigator: Jaynie Yang University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03672864     History of Changes
Other Study ID Numbers: Pro00078553
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Walking
Intensive exercise
Rehabilitation
Cerebral Palsy
Early intervention
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases