- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03620279
Magic Camp for Children With Hemiplegic Cerebral Palsy
torstai 20. helmikuuta 2020 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
7
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Alabama
-
Birmingham, Alabama, Yhdysvallat, 35294
- University of Alabama at Birmingham
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
9 vuotta - 18 vuotta (Lapsi, Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Magic camp intervention
These children are diagnosed with cerebral palsy and we will provide motor control training.
|
Hand-arm bimanual motor skills training
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Hon K Yuen, PhD, University of Alabama at Birmingham
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 4. kesäkuuta 2018
Ensisijainen valmistuminen (Todellinen)
Maanantai 1. lokakuuta 2018
Opintojen valmistuminen (Todellinen)
Maanantai 31. joulukuuta 2018
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 2. elokuuta 2018
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 2. elokuuta 2018
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 8. elokuuta 2018
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 24. helmikuuta 2020
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 20. helmikuuta 2020
Viimeksi vahvistettu
Lauantai 1. helmikuuta 2020
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB-300001044
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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Ei
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Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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