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Intensive Motor Training After Perinatal Stroke to Enhance Walking

NCT ID: NCT01773369

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2020-11-02

Brief Summary

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Early childhood injuries such as perinatal (around birth) stroke are devastating because the child lives with the problem for life, typically close to a normal lifespan. One 'opportunity' presented by a brain injury early in life compared to later in adulthood is that the young brain is much more plastic (malleable) and receptive to interventions. This is particularly true for neural circuits that are still under development. We will test the hypothesis that early (\<2 yr old), intensive leg training will improve walking more than no training or training at \>2 yr old. We will further determine the changes induced by training in motor and sensory pathways.

Detailed Description

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Children 8 mo to 3 yr old with unilateral perinatal stroke will be randomized into either: 1) Immediate Training, or 2) Delayed Training groups. The Immediate Group will train for 3 mo shortly after recruitment. The Delayed Group will go through the same measurements from the time of recruitment and at 3 mo later (with no training in between) to obtain a 3 mo change score which will serve as a control measure for the Immediate Group. The Delayed Group will also train after the 3 mo delay, when all control measures have been taken. Comparison of the improvements made by children who started training \<2 yr old with those \>2 yr old will answer the question if training at \<2 yr old is better than \>2 yr old. Finally, to determine if there are long term effects of this training, we will compare outcomes of these trained children with another group of children with the same injuries but no intensive training (i.e., too old for the training study), when all children turn 4 yr old. Clinical, kinematic and electrophysiological measures will be taken to help us understand not only the efficacy of the treatment, but also the neural mechanisms that might underlie improvements in outcome.

We are measuring outcomes at multiple times because change scores are of most interest. All children change as they age, so it is critical that we compare the change score with and without intervention.

Conditions

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Perinatal Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early treatment group

These children will undergo the intervention (i.e., early leg training) shortly after recruitment. Measures will be taken before, during and after the intervention.

Group Type EXPERIMENTAL

Early leg training

Intervention Type BEHAVIORAL

Children will engage in \~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by a physical therapist in the clinical setting.

Delayed treatment group

These children will undergo the intervention (delayed leg training) after a delay of \~3 months, during which outcome measures will be taken so that they can serve as a control for the early treatment group. Their intervention is identical to the Immediate treatment group.

Group Type EXPERIMENTAL

Delayed leg training

Intervention Type BEHAVIORAL

The training activity will be exactly the same as the Early leg training group, except that it will occur \~3 months after recruitment.

Control group

These children will be recruited close to the age of 4 years old, and will only undergo gait analysis and GMFM-66 scoring.

Group Type NO_INTERVENTION

No interventions assigned to this group

Parent training group

These children will undergo the intervention (i.e., parent leg training) shortly after recruitment. Parents will be trained to provide the intervention instead of a physical therapist. Measures will be taken before, during and after the intervention.

Group Type EXPERIMENTAL

Parent leg training

Intervention Type BEHAVIORAL

Children will engage in \~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by parents in their home or community environment.

Interventions

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Early leg training

Children will engage in \~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by a physical therapist in the clinical setting.

Intervention Type BEHAVIORAL

Delayed leg training

The training activity will be exactly the same as the Early leg training group, except that it will occur \~3 months after recruitment.

Intervention Type BEHAVIORAL

Parent leg training

Children will engage in \~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by parents in their home or community environment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* hemiplegia with confirmation of perinatal stroke through magnetic resonance imaging
* born near term (\> or equal to 36 weeks gestation)
* current age between 8 months to 3.0 years old; or currently 4 years old (control)
* no other neurological disorders
* informed consent from parent or guardian

Exclusion Criteria

* central nervous system injury besides the one-sided stroke
* musculoskeletal problems that limit leg activity
* cognitive, behavioral or developmental impairments that preclude participation in the protocol
* unstable epileptic seizures within the last 6 months
* any contraindications to transcranial magnetic stimulation
* Botox injection in the legs over the last 6 months
Minimum Eligible Age

8 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Innovates Health Solutions

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaynie Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Monica Gorassini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Hurd C, Livingstone D, Brunton K, Smith A, Gorassini M, Watt MJ, Andersen J, Kirton A, Yang JF. Early, Intensive, Lower Extremity Rehabilitation Shows Preliminary Efficacy After Perinatal Stroke: Results of a Pilot Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Jun;36(6):360-370. doi: 10.1177/15459683221090931. Epub 2022 Apr 15.

Reference Type DERIVED
PMID: 35427191 (View on PubMed)

Other Identifiers

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Pro00032297

Identifier Type: -

Identifier Source: org_study_id