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

18 giugno 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

19

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 1 anno a 3 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: high-intensity group
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
Altro: 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
Dispositivo: Tapis roulant
Comparatore attivo: low-intensity group
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
Altro: 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
Dispositivo: Tapis roulant

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gross Motor Function Measure Dimension E
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pediatric Evaluation of Disability Index-Mobility Subscale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

California State University, Sacramento

Collaboratori

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

Investigatori

  • Direttore dello studio: David Earwicker, BA,MA, California State University, Sacramento

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2015

Completamento primario (Effettivo)

1 settembre 2018

Completamento dello studio (Effettivo)

1 settembre 2018

Date di iscrizione allo studio

Primo inviato

16 aprile 2015

Primo inviato che soddisfa i criteri di controllo qualità

22 aprile 2015

Primo Inserito (Stima)

23 aprile 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2020

Ultimo verificato

1 giugno 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 13-14-156

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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