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

NCT03672877 | Active Not Recruiting

• 1 other identifier: Pro00080569
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Spastic Diplegia; Periventricular Leukomalacia

Keywords

Physical Therapy; Rehabilitation; Walking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP)

  From Baseline to 6 months

• Change in stiffness at the ankle

  From Baseline to 6 months

Study Arms (2)

Immediate training group

EXPERIMENTAL

Children will participate in intensive exercise intervention for 3 months and will be followed for 9 months following the intervention

Behavioral: Intensive exercise

Delay training group

NO INTERVENTION

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.

Interventions

Intensive exercise BEHAVIORAL

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.

Immediate training group

Eligibility Criteria

• Age: 8 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Bilateral motor impairment of the lower extremities
• Periventricular white matter injury from encephalopathy of prematurity
• Able to stand with some support

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jaynie Yang, Phd

  Universtiy of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physical therapy assessors will be blinded to the child's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: January 28, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

CA (2)