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Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy

18 juni 2020 bijgewerkt door: Katrin Mattern-Baxter, California State University, Sacramento
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.

Hypotheses

  • A more intensive protocol of treadmill training will increase walking onset in young children with CP.
  • A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.

Specific Aims

  • To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
  • To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.

Study design •Prospective randomized controlled trial

Study population

•Two groups of 12 children with CP under the age of 3 years and are not walking yet will receive either home-based high-intensity treadmill training or low-intensity treadmill training. The children will be assessed before, immediately after, at 1-month and at 4-months following the intervention via standardized outcome measures.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

19

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Washington
      • Seattle, Washington, Verenigde Staten, 98145
        • Seattle Children's Research Institute
      • Tacoma, Washington, Verenigde Staten, 98416
        • University of the Puget Sound

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 jaar tot 3 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.

  • Because young children often are not formally diagnosed with CP until 2 years of age, we will include children

    • who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
    • who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
    • who have been identified as high-risk for a motor disability by a physician

Exclusion Criteria:

  • a history of uncontrolled seizures
  • a diagnosis of a genetic disorder
  • cardiac or orthopedic contraindications for standing and walking
  • orthopedic surgery in the past 6 months
  • use of spasticity-reducing medication or Botox injections in the past 6 months

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: high-intensity group
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
Ander: home-based treadmill training
the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Apparaat: Loopband
Actieve vergelijker: low-intensity group
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
Ander: home-based treadmill training
the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Apparaat: Loopband

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gross Motor Function Measure Dimension E
Tijdsspanne: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
assessed at 6 weeks, 1 month, 4 months from baseline
Walking Activity Measured by StepWatch
Tijdsspanne: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.
StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
Gross Motor Function Measure Dimension D
Tijdsspanne: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.
assessed at 6 weeks, 1 month, 4 months from baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pediatric Evaluation of Disability Index-Mobility Subscale
Tijdsspanne: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
The Pediatric Evaluation of Disability Index is a valid and reliable tool that provides an assessment of a child's functional status and performance via observation and parent report.The Mobility Subscale examines the child's functional skills related to movement. There are a total of 13 motor categories on the Mobility Subscale, with 5 possible motor skills in each category, for a total of 65 distinct motor skills. Skills are marked as 0 (not observed) or 1 (observed) and added.There are a total of 65 possible points with a range of 0-65 points on the Mobility Subscale. Higher scores indicate greater function.Scores are reported as changes from baseline.
pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
Timed 10-meter Walk Test
Tijdsspanne: assessed at 6 weeks, at 1-month and at 4-months following the intervention
The child's walking speed is recorded over 10 meters if the child is able to walk with or without an assistive device. The speed is timed and reported in seconds. Fewer seconds indicate a faster walking speed. Time in seconds is reported as change from baseline.
assessed at 6 weeks, at 1-month and at 4-months following the intervention
Peabody Developmental Motor Scales-2 -Locomotion Subscale
Tijdsspanne: assessed at 6 weeks, at 1-month and at 4-months
Peabody Developmental Motor Scales-2 is a norm-referenced standardized test of gross and fine motor performance for children from birth through age 5.The Locomotion Subscale examines the ability of the child to move through space. It contains a total of 89 motor skills. The child is rated on each skill on a scale of 0 (unable), 1 (partial) or 2 (complete) and the scores are added for a total possible raw score of 178 and a range of 0-178. Higher raw scores indicate a better outcome.The raw scores can be converted to standard scores, age equivalents and percentiles Raw scores of the Locomotion subscale are reported based on changes from baseline.
assessed at 6 weeks, at 1-month and at 4-months
1-minute Walk Test
Tijdsspanne: assessed at 6 weeks, 1 month, 4 months
The child's walking distance is measured in meters over 1 minute at their self-selected walking speed if the child is able to walk with or without an assistive device.The walking distance is reported in meters. More meters indicate more distance covered. Values are reported in meters as changes from baseline.
assessed at 6 weeks, 1 month, 4 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

California State University, Sacramento

Medewerkers

Seattle Children's Hospital
Thrasher Research Fund
University of Puget Sound

Onderzoekers

  • Studie directeur: David Earwicker, BA,MA, California State University, Sacramento

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2015

Primaire voltooiing (Werkelijk)

1 september 2018

Studie voltooiing (Werkelijk)

1 september 2018

Studieregistratiedata

Eerst ingediend

16 april 2015

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2015

Eerst geplaatst (Schatting)

23 april 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2020

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2020

Laatst geverifieerd

1 juni 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 13-14-156

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

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