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

Primary Purpose

Spastic Diplegia, Periventricular Leukomalacia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intensive exercise
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Diplegia focused on measuring Physical Therapy, Rehabilitation, Walking

Eligibility Criteria

8 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's HospitalRecruiting
  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate training group

Delay training group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 13, 2018
Last Updated
May 1, 2023
Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03672877
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegia, Periventricular Leukomalacia
Keywords
Physical Therapy, Rehabilitation, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Physical therapy assessors will be blinded to the child's group assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate training group
Arm Type
Experimental
Arm Description
Children will participate in intensive exercise intervention for 3 months and will be followed for 9 months following the intervention
Arm Title
Delay training group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Gross Motor Functional Measure - 66 Items (GMFM-66)
Description
This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.
Time Frame
From Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change on Pediatric Quality of Life Measure module for cerebral palsy (PedsQL CP)
Description
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.
Time Frame
From Baseline to 6 months
Title
Change in stiffness at the ankle
Description
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.
Time Frame
From Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Livingstone, BScPT
Phone
780-492-4858
Email
carre@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaynie Yang, Phd
Organizational Affiliation
Universtiy of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Barnes, BScPT
Phone
780-492-4858
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Elizabeth Condliffe
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Barnes, BScPT
Phone
780-492-4858
Email
carre@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Jaynie Yang, PhD

12. IPD Sharing Statement

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

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