Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia

November 4, 2020 updated by: University of Alberta

Early Intensive Exercise to Improve Walking in Children With Spastic 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 motor function in the legs in young children with spastic diplegia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP), most often affecting the legs, called spastic diplegia. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (Botox) 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 with mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. Building on the success with early, intensive therapy for children with perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 3 mo. The delay period controls for improvement without treatment. These children will also receive treatment after the delay period. The therapy will be guided by physical therapists, and similar to the project on perinatal stroke. Children who live beyond commuting distance from the centres will form a 3rd group, whose parents will be coached by therapists to train the child at home. This group will show whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old, they will be compared to other 4-yr-old children with the same diagnosis, but no training, to determine if there are long term benefits. The investigators anticipate that like the children with perinatal stroke, early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2G4
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Group
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
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.
Other Names:
  • Therapist training
Experimental: Delay Group
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
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.
Other Names:
  • Therapist training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months
Time Frame: Baseline, 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in forces during treadmill walking over 3 months
Time Frame: Baseline, 3 months
The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaynie Yang, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00072587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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