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

NCT03672877 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Alberta

    lead OTHER

Principal Investigators

  • Jaynie Yang, Phd · Universtiy of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672877 on ClinicalTrials.gov