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Perinatal StrokeNCT01773369

Intensive Motor Training After Perinatal Stroke to Enhance Walking

A study testing Early leg training, Delayed leg training and Parent leg training in people with Perinatal Stroke, run by University of Alberta at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 8 months to 4 years
Conditions the study is for
Perinatal Stroke
What is being tested?
Early leg training, Delayed leg training and Parent leg training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesCanada
Study dates
1 Nov 2012to 2 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 months to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Alberta Children's Hospital

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta, T6G 2G4

Other trials in Canada

About this study

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.

Read the detailed description

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.

Being tested
Early leg training, Delayed leg training, Parent leg training
Keywords
cerebral palsy, physical therapy, rehabilitation, hemiplegia
Medical subject headings
Cerebral Palsy, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early leg trainingBehavioural

    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 leg trainingBehavioural

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

  • Parent leg trainingBehavioural

    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.

Study groups in NCT01773369
Study groupRoleWhat they receive
Early treatment groupExperimentalThese children will undergo the intervention (i.e., early leg training) shortly after recruitment. Measures will be taken before, during and after the intervention.
Receives: Behavioral: Early leg training
Delayed treatment groupExperimentalThese 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.
Receives: Behavioral: Delayed leg training
Control groupNo interventionThese children will be recruited close to the age of 4 years old, and will only undergo gait analysis and GMFM-66 scoring.
Parent training groupExperimentalThese 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.
Receives: Behavioral: Parent leg training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline

    This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), monthly measures will occur thereafter for 6 months, then one final assessment when the child turns 4 years old, for a total of 9 measures.

    Measured: Pre baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months and at 4 years of age

Secondary outcomes (5)

  1. Change in kinematics and forces during treadmill walking from baseline

    The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), then after each of the training/delay periods, for a total of 5 measures.

    Measured: Pre baseline, 3 months, 6 months

  2. Change in tendon reflexes from baseline

    The patellar tendon reflexes will be induced by tapping the left and right tendon using a reflex hammer. The response in leg muscles will be recorded with surface electromyography. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.

    Measured: Pre baseline, 3 months, 6 months and at 4 years of age

  3. Change in transcranial magnetic stimulation from baseline

    Transcranial magnetic stimulation (TMS) is a non-invasive way to activate brain cells. A single or double pulse is applied over the motor area of the brain (feels like a tap to the head), and the response is measured in leg muscles using electromyography. The safety concern is that people who are prone to seizures or have implants in their head should not have TMS. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.

    Measured: Pre baseline, 3 months, 6 months, at 4 years of age

  4. Change in activity monitored at home from baseline

    The child will wear a small activity monitor on each ankle for 3 days, so that we can determine how active the child is at home. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old, for a total of 5 measures.

    Measured: Pre baseline, 3 months, 6 months, at 4 years of age

  5. Gait analysis

    The child's walking over ground will be recorded with video cameras, force plates and surface electromyography to determine their walking pattern at 4 years old. This measure will be taken just once when the child is age 4 yr old

    Measured: At 4 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2013 (estimated)
  2. Study start1 Nov 2012
  3. Primary completion25 Jun 2019
  4. Study completion2 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01773369
Sponsor's protocol ID
Pro00032297
Status last verified
Nov 2020
First submitted
30 Nov 2012
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35427191

Questions about this trial

What is this clinical trial studying?

A study testing Early leg training, Delayed leg training and Parent leg training in people with Perinatal Stroke, run by University of Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline (time frame: Pre baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months and at 4 years of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01773369, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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