Magic Camp for Children With Hemiplegic Cerebral Palsy
20. února 2020 aktualizováno: Hon K. Yuen, PhD, University of Alabama at Birmingham
The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children with spastic hemiplegic cerebral palsy (CP).
A single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "Magic Camp" on improving upper limb motor function and health-related quality of life (HRQoL) in children with hemiplegic CP.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
This project will employ a single group pretest-posttest design to investigate the impact of a "Magic Camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic CP.
After the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks.
The primary outcome measures will be unimanual function as measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the Children's Hand Experience Questionnaire.
Secondary outcome measures will include HRQoL as measured by the Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.
Typ studie
Intervenční
Zápis (Aktuální)
7
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Alabama
-
Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
9 let až 18 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- spasticity with Modified Ashworth Scale grades between 1 and 3;
- ability to lift the more affected arm 15 cm above a table surface;
- impairment of hand function at levels I to III of the Manual Activity Classification System
- ability to grasp and release light objects with the more affected hand
- largely nonuse of the more affected hand in daily activities as determined by the Pediatric Motor Activity Log
- are interested in learning magic tricks
- have the cognitive and social ability to participate in a camp setting;
- ability to follow directions in English; and
- ability to remember simple sequences of actions to perform magic tricks.
Exclusion Criteria:
- severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use
- dystonia
- severe visual or auditory disorders that prevent learning and carrying out the magic tricks
- serious or recurring medical complications
- participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months
- start muscle relaxant within the last 3 months; or
- plan to move to another state within the next 6 months.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Magic camp intervention
These children are diagnosed with cerebral palsy and we will provide motor control training.
|
Hand-arm bimanual motor skills training
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Časové okno: baseline
|
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by occupational therapy (OT) students to assess the efficiency of unimanual grasp and release of items with six tasks.
Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills
|
baseline
|
|
Bimanual coordination as measured by 3-D kinematic motion analysis
Časové okno: baseline
|
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal.
Each trial ends when the button is pressed.
Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.
Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
|
baseline
|
|
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Časové okno: Baseline
|
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required.
Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items.
Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
|
Baseline
|
|
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Časové okno: Baseline
|
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being.
Items are rated on a 9-point scale, and recoded and transformed into scaled scores (transformed to a scale of 1-100) for each domain.
An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted.
Higher scores represent better health-related quality of life.
|
Baseline
|
|
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
Časové okno: Baseline
|
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample.
Nail samples will be sent to the Bio-Analytical Redox Biology (BARB) Core Laboratory, University of Alabama at Birmingham (UAB) for analysis.
|
Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Časové okno: from baseline to two weeks
|
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by OT students to assess the efficiency of unimanual grasp and release of items with six tasks.
Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills.
|
from baseline to two weeks
|
|
Bimanual coordination as measured by 3-D kinematic motion analysis
Časové okno: from baseline to two weeks
|
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal.
Each trial ends when the button is pressed.
Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
|
from baseline to two weeks
|
|
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Časové okno: from baseline to two weeks
|
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required.
Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items.
Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
|
from baseline to two weeks
|
|
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Časové okno: from baseline to two weeks
|
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being.
Items are rated on a 9-point scale, and recoded and transformed into scaled scores for each domain.
An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted.
Higher scores represent better health-related quality of life.
|
from baseline to two weeks
|
|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Časové okno: from two weeks to three months
|
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by OT students to assess the efficiency of unimanual grasp and release of items with six tasks.
Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills.
|
from two weeks to three months
|
|
Bimanual coordination as measured by 3-D kinematic motion analysis
Časové okno: from two weeks to three months
|
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal.
Each trial ends when the button is pressed.
Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.
Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
|
from two weeks to three months
|
|
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Časové okno: from two weeks to three months
|
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required.
Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items.
Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
|
from two weeks to three months
|
|
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Časové okno: from two weeks to three months
|
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being.
Items are rated on a 9-point scale, and recoded and transformed into scaled scores for each domain.
An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted.
Higher scores represent better health-related quality of life.
|
from two weeks to three months
|
|
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
Časové okno: from baseline to three months
|
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample.
Nail samples will be sent to the BARB Core Laboratory, UAB for analysis.
|
from baseline to three months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Hon K Yuen, PhD, University of Alabama at Birmingham
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
4. června 2018
Primární dokončení (Aktuální)
1. října 2018
Dokončení studie (Aktuální)
31. prosince 2018
Termíny zápisu do studia
První předloženo
2. srpna 2018
První předloženo, které splnilo kritéria kontroly kvality
2. srpna 2018
První zveřejněno (Aktuální)
8. srpna 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. února 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. února 2020
Naposledy ověřeno
1. února 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-300001044
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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produkt vyrobený a vyvážený z USA
Ne
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