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

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.

Study Overview

• Status: Recruiting
• Conditions: Spastic Diplegia; Periventricular Leukomalacia
• Intervention / Treatment: Behavioral: Intensive exercise

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donna Livingstone, BScPT; Phone Number: 780-492-4858; Email: carre@ualberta.ca

Study Locations

• Canada
  • 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: 8 months to 3 years (Child)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gross Motor Functional Measure - 66 Items (GMFM-66)	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)	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	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: University of Alberta
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jaynie Yang, Phd, Universtiy of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Therapy; Walking
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Infant, Newborn, Diseases; Infant, Premature, Diseases; Encephalomalacia; Cerebral Palsy; Leukomalacia, Periventricular
• Other Study ID Numbers: Pro00080569

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No