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Magic Camp for Children With Hemiplegic Cerebral Palsy

20 febbraio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

7

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
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • University of Alabama at Birmingham

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 9 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Magic camp intervention
These children are diagnosed with cerebral palsy and we will provide motor control training.
Comportamentale: Magic camp intervention
Hand-arm bimanual motor skills training

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

University of Alabama at Birmingham

Investigatori

  • Investigatore principale: Hon K Yuen, PhD, University of Alabama at Birmingham

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)

4 giugno 2018

Completamento primario (Effettivo)

1 ottobre 2018

Completamento dello studio (Effettivo)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

2 agosto 2018

Primo inviato che soddisfa i criteri di controllo qualità

2 agosto 2018

Primo Inserito (Effettivo)

8 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 febbraio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 febbraio 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB-300001044

Piano per i dati dei singoli partecipanti (IPD)

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

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

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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