- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03681171
Therapeutic Dance Intervention for Children With Cerebral Palsy
20 september 2018 uppdaterad av: Shlomit Aizik
A Pilot Study of a Therapeutic Dance Intervention for Children With Cerebral Palsy
Children with cerebral palsy (CP) have motor impairments that make it challenging for them to participate in standard physical activity (PA) programs.
There is a need to evaluate adapted PA programs for this population.
Dance can promote coordination, posture, muscle strength, motor learning, and executive functioning.
This pilot study evaluated the feasibility and the effects of a new therapeutic ballet intervention specifically designed for children with CP on physiological and executive functions outcomes.
Studieöversikt
Detaljerad beskrivning
8 children with CP (9-14y/o; 75% female) participated in a six-week therapeutic ballet program.
Participants had body composition (DXA), muscle strength (hand-grip dynamometer), habitual physical activity, gait and selective motor control functions, and executive function tasks before and after the intervention.
Follow-up assessments of habitual physical activity, gait and executive functions were completed four to five week post-intervention.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 15 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Cerebral palsy spastic diplegia and/or hemiplegia
- Absence of health problems that would preclude participation in exercise
- Male or female age 9 - 15 years inclusive at the time of consent
- Minimum level of intellectual functioning (e.g., as determined by an IQ score of 80 or above or other education placement and testing indicating sufficient understanding)
- Ability to complete study measures at the assessment
- Ability to participate in dance classes conducted in English
- Interest in learning ballet
- Intact vision
- Intact hearing
- Able to ambulate independently in the community with or without a device
- Intact proprioception in lower extremities
- Able to complete assessment measures and consents in English
- Referral from the child's pediatrician or other physician indicating that the child is physically able to participate in an exercise intervention
Exclusion Criteria:
- Children with a current diagnosis of severe Major Depressive Disorder
- Generalized Anxiety Disorder
- Epilepsy
- Autism
- Other major medical conditions that prohibit full participation and children with severe developmental disorders (e.g., mental retardation, severe autism) or with physical impairments that prohibit full participation were excluded from the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Children with CP
Children with CP (9-15 years old) participated in a therapeutic dance program to improve physical, physiological and cognitive outcomes.
|
Participants attended therapeutic ballet sessions three times per week for six weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Gait (GAITRite© system)
Tidsram: 12 weeks
|
Assessment before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention
|
12 weeks
|
Executive Functions measured by Hearts and Flowers Flanker Tasks
Tidsram: 12 weeks
|
Measures attention and working memory before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
|
12 weeks
|
Executive Functions measured by Stroop Colored Word Test
Tidsram: 12 weeks
|
Measures inhibitory control before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
|
12 weeks
|
Executive Functions measured by BRIEF (Parent Questionnaire)
Tidsram: 12 weeks
|
An 86-item questionnaire
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Tidsram: 8 weeks
|
Assessment of Lean Body Mass
|
8 weeks
|
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Tidsram: 8 weeks
|
Assessment of Percent Body Fat
|
8 weeks
|
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Tidsram: 8 weeks
|
Assessment of bone density
|
8 weeks
|
Muscle Strength
Tidsram: 8 weeks
|
Handgrip (evaluated maximum isometric strength (Kg) before and after six-week therapeutic ballet program.
|
8 weeks
|
CBC
Tidsram: 8 weeks
|
Includes hemoglobin measures for anemia and inflammation factors
|
8 weeks
|
Lipid Panel
Tidsram: 8 weeks
|
CVD risk factors (lipid screen ) before and after six-week therapeutic ballet program
|
8 weeks
|
Habitual Physical Activity assessment
Tidsram: 12 weeks
|
Physical activity was measured using ActiGraph accelerometers before and immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
|
12 weeks
|
Social and Emotional Functioning measured by Self-Efficacy Survey (Child)
Tidsram: 8 weeks
|
Measures individual perceptions of one's capacity to manage one's functioning and control over events before and after six-week therapeutic ballet program.
|
8 weeks
|
Social and Emotional Functioning measured by Self-Perception Profile for Children
Tidsram: 8 weeks
|
Measures Scholastic Competence, Athletic Competence, Social Competence, Physical Appearance, and Behavioral Conduct.
|
8 weeks
|
Social and Emotional Functioning measured by Positive Affect Survey.
Tidsram: 8 weeks
|
Measures feelings of pleasurable engagement with the environment (happiness, joy, excitement, engagement).
|
8 weeks
|
Social and Emotional Functioning measured by Perceived Stress Self-Report Scale
Tidsram: 8 weeks
|
Asks participants to rate how they have felt over the last month
|
8 weeks
|
Social and Emotional Functioning measured by Strengths and Difficulties Questionnaire (SDQ)
Tidsram: 8 weeks
|
SDQ is a brief questionnaire that assesses children's emotional problems
|
8 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Shlomit Aizik, PhD, University of California, Irvine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 juni 2016
Primärt slutförande (Faktisk)
1 augusti 2016
Avslutad studie (Faktisk)
1 september 2016
Studieregistreringsdatum
Först inskickad
30 augusti 2018
Först inskickad som uppfyllde QC-kriterierna
20 september 2018
Första postat (Faktisk)
21 september 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 september 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 september 2018
Senast verifierad
1 september 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2016-2682
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Cerebral pares
-
University of Southern CaliforniaRekrytering
-
Fondazione Policlinico Universitario Agostino Gemelli...Avslutad
-
Sofregen Medical, Inc.AvslutadStämbandsförlamning | Stämbandsatrofi | Vocal Fold PalsyFörenta staterna
-
UMC UtrechtAvslutadKardiopulmonell bypass | Cerebral perfusion | Cerebral syresättningNederländerna
-
University College, LondonSmiths Medical, ASD, Inc.AvslutadStämbandsförlamning | Dysfoni | Muskelspänningsdysfoni | Vocal Fold Palsy | PresbylarynxStorbritannien
-
Xuanwu Hospital, BeijingAnmälan via inbjudanDynamisk cerebral autoreglering | Halspulsåderstent | Cerebral artärstenosKina
-
Changhai HospitalRekrytering
-
Huashan HospitalHar inte rekryterat ännu
-
Seoul National University HospitalHar inte rekryterat ännu
-
China Medical University, ChinaAvslutad
Kliniska prövningar på Therapeutic Dance
-
Boston Medical CenterHar inte rekryterat ännuSubstansmissbruk | Problem med psykisk hälsaFörenta staterna
-
Babes-Bolyai UniversityAktiv, inte rekryterandeREThink Game | Behandling som vanligtRumänien
-
Cognoa, Inc.AvslutadAutismspektrumstörningFörenta staterna
-
Universidad Miguel Hernandez de ElcheHospital Universitario San Juan de AlicanteAvslutadRyggsmärta Nedre delen av ryggen KroniskSpanien
-
NightWareRationalPsych; Center for International Emergency Medical ServicesAvslutadSömnstörning | Sömninitiering och underhållsstörningar | Stresssyndrom | Stridsstörningar | Mardröm | Posttraumatisk stressyndrom | Mardrömmar, REM-sömntyp | Mardrömmar associerade med kronisk posttraumatisk stressyndromFörenta staterna
-
University of VermontNational Institute of Arthritis and Musculoskeletal and Skin Diseases... och andra samarbetspartnersAvslutadKronisk smärta och återfallsförebyggandeFörenta staterna
-
National Institute of Diabetes and Digestive and...University of PennsylvaniaAvslutadInterstitiell cystit | Smärtsamt blåssyndrom | Kronisk prostatit | Kroniskt bäckensmärta syndromFörenta staterna
-
Fresenius Medical Care Deutschland GmbHX-act Cologne Clinical Research GmbHHar inte rekryterat ännu
-
Alliance for International Medical ActionInstitut National de la Santé Et de la Recherche Médicale, France; Institut... och andra samarbetspartnersAvslutadGlobal akut undernäring (GAM)Burkina Faso
-
Universidade Federal de Sao CarlosAvslutad