Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
18 czerwca 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
19
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Washington
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Seattle, Washington, Stany Zjednoczone, 98145
- Seattle Children's Research Institute
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Tacoma, Washington, Stany Zjednoczone, 98416
- University of the Puget Sound
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
1 rok do 3 lata (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: high-intensity group
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
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the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
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Aktywny komparator: low-intensity group
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
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the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Gross Motor Function Measure Dimension E
Ramy czasowe: 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.
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assessed at 6 weeks, 1 month, 4 months from baseline
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Walking Activity Measured by StepWatch
Ramy czasowe: 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.
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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.
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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.
|
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Gross Motor Function Measure Dimension D
Ramy czasowe: 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.
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assessed at 6 weeks, 1 month, 4 months from baseline
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pediatric Evaluation of Disability Index-Mobility Subscale
Ramy czasowe: 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.
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pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
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Timed 10-meter Walk Test
Ramy czasowe: assessed at 6 weeks, at 1-month and at 4-months following the intervention
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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.
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assessed at 6 weeks, at 1-month and at 4-months following the intervention
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Peabody Developmental Motor Scales-2 -Locomotion Subscale
Ramy czasowe: assessed at 6 weeks, at 1-month and at 4-months
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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.
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assessed at 6 weeks, at 1-month and at 4-months
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1-minute Walk Test
Ramy czasowe: assessed at 6 weeks, 1 month, 4 months
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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.
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assessed at 6 weeks, 1 month, 4 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Dyrektor Studium: David Earwicker, BA,MA, California State University, Sacramento
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 lipca 2015
Zakończenie podstawowe (Rzeczywisty)
1 września 2018
Ukończenie studiów (Rzeczywisty)
1 września 2018
Daty rejestracji na studia
Pierwszy przesłany
16 kwietnia 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 kwietnia 2015
Pierwszy wysłany (Oszacować)
23 kwietnia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 lipca 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 czerwca 2020
Ostatnia weryfikacja
1 czerwca 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 13-14-156
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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