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

Periventricular Leukomalacia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03672877
• Other study ID #: Pro00080569
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Alberta
• Contact: Donna Livingstone, BScPT
• Phone: 780-492-4858
• Email: carre[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Leukomalacia, Periventricular
• Periventricular Leukomalacia
• Spastic Diplegia

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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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