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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Canadian Institutes of Health Research (CIHR) |
Canada,
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 |
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