Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia

NCT03166293 | Completed

• 1 other identifier: Pro00072587
• Study Type: interventional
• Target: 4
• 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 motor function in the legs in young children with spastic diplegia.

Conditions

Spastic Diplegia

Keywords

Cerebral Palsy; Physical Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months

  This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.

  Baseline, 3 months

Secondary Outcomes (1)

• Change in forces during treadmill walking over 3 months

  Baseline, 3 months

Study Arms (2)

Immediate Group

EXPERIMENTAL

Children will participate in intensive leg training with a physical therapist 1 hour/day, 4 days/week for 12 weeks. Children will continue to receive standard physical therapy care. Children will be followed for one year from the time of enrollment in the study.

Behavioral: Intensive leg training with a physical therapist

Delay Group

EXPERIMENTAL

Children will be monitored for 3 months with no intervention. Children will participate in intensive leg training with a physical therapist after the 3 month delay period. Training will be 1 hour/day, 4 days/week for 12 weeks. They will continue to receive standard care throughout. Children will be followed for one year from the time of enrollment in the study.

Behavioral: Intensive leg training with a physical therapist

Interventions

Intensive leg training with a physical therapist BEHAVIORAL

Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (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. A physical therapist will supervise sessions.

Also known as: Therapist training

Delay Group; Immediate Group

Eligibility Criteria

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

You may qualify if:

• children aged 8 mo - 3 yr old
• Evidence of periventricular white matter injury on diagnostic imaging
• clinical evidence of spastic diplegia

You may not qualify if:

• born before gestational age of 25 weeks
• birth weight \<1000g (to exclude confounds related to extreme prematurity and low birth weights)
• MRI evidence of diffuse injury to the cerebral or cerebellar cortex
• uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
• cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
• Botulinum toxin (BTX-A) injections in the last 6 months
• Predicted GMFCS 4 or 5

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jaynie Yang, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Monica Gorassini, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive 3 months of intervention or 3 months of observation. Participants in the observation group will be offered the intervention once the observation period is complete

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: June 1, 2017
• Primary Completion: January 4, 2019
• Study Completion: November 3, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)