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Trial record 2 of 27 for:    "Periventricular Leukomalacia"

Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia

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ClinicalTrials.gov Identifier: NCT03672877
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.

Condition or disease Intervention/treatment Phase
Spastic Diplegia Periventricular Leukomalacia Behavioral: Intensive exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to receive 3 months of intervention immediately (Immediate Group) or to be observed for 6 months (Delay Group). Participants in the Delay Group will be offered the intervention once the observation period is complete.
Masking: Single (Outcomes Assessor)
Masking Description: Physical therapy assessors will be blinded to the child's group assignment.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia From Encephalopathy of Prematurity
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : December 31, 2024


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
Behavioral: Intensive exercise
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.



Primary Outcome Measures :
  1. Change in Gross Motor Functional Measure - 66 Items (GMFM-66) [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.


Secondary Outcome Measures :
  1. Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP) [ 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 ]
    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.



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Ages Eligible for Study:   8 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03672877


Contacts
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Contact: Donna Livingstone, BScPT 780-492-4858 carre@ualberta.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Not yet recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Donna Livingstone, BScPT    780-492-4858    carre@ualberta.ca   
Principal Investigator: Elizabeth Condliffe         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Donna Livingstone, BScPT    780-492-4858    carre@ualberta.ca   
Principal Investigator: Jaynie Yang, PhD         
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Jaynie Yang, Phd Universtiy of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03672877     History of Changes
Other Study ID Numbers: Pro00080569
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: November 2018

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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:
Physical Therapy
Rehabilitation
Walking

Additional relevant MeSH terms:
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Cerebral Palsy
Leukomalacia, Periventricular
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases