Clinical trial NCT03672877: Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia
Official title: Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia From Encephalopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spastic Diplegia
Periventricular Leukomalacia
Keywords: Physical Therapy
Rehabilitation
Walking
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gross Motor Functional Measure - 66 Items (GMFM-66)
timeFrame: From Baseline to 6 months
Secondary outcomes:
measure: Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP)
timeFrame: From Baseline to 6 months
measure: Change in stiffness at the ankle
timeFrame: From Baseline to 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Universtiy of Alberta
name: Jaynie Yang, Phd
role: PRINCIPAL_INVESTIGATOR
References: