- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672877
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia From Encephalopathy of Prematurity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children born prematurely are at risk of brain injury that can result in cerebral palsy, most often affecting both legs. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (botulinum toxin) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work in mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young.
Building on our success with early, intensive therapy for children with perinatal stroke, we will apply intensive therapy for the legs in children with cerebral palsy involving both legs. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 6 months. The delay period controls for improvement without treatment. The children in the Delay Group will have the option to receive the same treatment after the delay period. The therapy will be guided by physical therapists, and centered on play. Measures will be taken before, during and after the delay and treatment periods. Measures will include clinical scores of motor development, proficiency of walking, participation at home, and physiological measures of motor and sensory function. All children will be followed until they turn 4 yr old, to determine if there are long term benefits. The cost-effectiveness of the intervention will be evaluated by a health economist. We anticipate that early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Donna Livingstone, BScPT
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Recruiting
- Alberta Children's Hospital
-
Principal Investigator:
- Elizabeth Condliffe
-
Contact:
- Michelle Barnes, BScPT
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
-
Edmonton, Alberta, Canada, T6G 2G4
- Recruiting
- University of Alberta
-
Principal Investigator:
- Jaynie Yang, PhD
-
Contact:
- Michelle Barnes, BScPT
- Phone Number: 780-492-4858
- Email: carre@ualberta.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Bilateral motor impairment of the lower extremities
- Periventricular white matter injury from encephalopathy of prematurity
- Able to stand with some support
Exclusion Criteria:
- Substantial upper extremity involvement - Manual Abilities Classification System (MACS) Level ≥3
- Uncontrolled epilepsy or infantile spasms in the past 6 months
- Cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
- Botulinum toxin-A (BTX-A) injections in the legs in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate training group
Children will participate in intensive exercise intervention for 3 months and will be followed for 9 months following the intervention
|
Intensive, child-initiated activities of the lower extremities including walking (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities.
Small weights will be added to the ankle and foot to increase the intensity of the exercise.
Sessions will be one hour long, 4 days a week.
A physical therapist or designate will supervise sessions.
|
No Intervention: Delay training group
Children will be assessed for 6 months with no intervention.
After the 6 month period children will be given the same intervention as the immediate group and followed for 3 months after the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Gross Motor Functional Measure - 66 Items (GMFM-66)
Time Frame: From Baseline to 6 months
|
This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.
|
From Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP)
Time Frame: From Baseline to 6 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.
|
From Baseline to 6 months
|
Change in stiffness at the ankle
Time Frame: From Baseline to 6 months
|
The portable spasticity assessment device (PSAD) will be used to measure response to stretch in the ankle plantarflexors.
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.
|
From Baseline to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaynie Yang, Phd, Universtiy of Alberta
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00080569
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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