The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
31. januar 2022 oppdatert av: Areum Jensen, San Jose State University
Cerebral palsy (CP) is a neurodevelopmental disorder and is the most common childhood disability.
CP is characterized by abnormal development, impaired motor function, and muscular and skeletal abnormalities.
Due to their diminished musculoskeletal function, individuals with CP suffer a high rate of moderate to severe bone fractures, which can lead to further immobility.
Optimizing muscle and bone health with exercise may be important in minimizing fractures from limited mobility, and fundamental for maximizing health-related quality of life.
The main purpose of this research is to investigate the effect of exercise training on musculoskeletal system in individuals with CP, with the goal of reducing the incidence of falls and fractures.
To accomplish these aims, musculoskeletal health will be assessed using various physiological techniques (e.g., Dual energy X-ray Absorptiometry, Humac Norm Isokinematic System, Biodex Balance System) before, during, and after one year of exercise training in individuals with CP.
In addition, various functional mobility tests to quantify fitness levels will be performed.
Findings may lead to the development of novel therapeutic interventions targeted at improving musculoskeletal health in individuals with CP.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
29
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
San Jose, California, Forente stater, 95192
- San Jose State University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- those who can follow simple commands and walk independently with or without the use of an assistance apparatus (within Classification level I-III, based on Gross Motor Functioning Classification System, GMFCS) and have cerebral palsy will be included in the study. The rationale for such inclusion criteria (level I-III) is to make sure they can perform some leg exercise and tests.
Exclusion Criteria:
- If subjects have a history or symptoms of cardiovascular, renal, hepatic, or respiratory diseases, they will be excluded in the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Resistance/strength training
|
Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Height measurement
Tidsramme: 1 minute
|
Height (cm) will be measured using a standard beam scale with height rod.
This anthropometric measurement is used to assess general body size.
Body mass index is calculated and reported.
|
1 minute
|
|
Body composition
Tidsramme: 8 minutes
|
Whole body Dual energy X-ray absorptiometry (DXA) will be measured to assess overall body composition for the mass of the bone, muscle, and fat in the whole body.
For those who do not complete DXA due to severe spasticity, a bioelectrical impedance technique (BIA) using 4 electrode unit Biodynamics Model 310 Body Composition Analyzer will be used to quantify fat mass, fat free mass, and water content.
BIA does not use x-ray; thus, participants will not be exposed additional radiation.
|
8 minutes
|
|
Muscular strength
Tidsramme: 15 minutes
|
Participants will perform leg press, leg curl, and leg extension at submaximal level to predict 1-Repetition Masimum using Brzycki equations.
In addition, participants will perform knee extension and flexion testing using Humac Norm Isokinetic Dynamometer to measure isometric and isokinetic muscular strength in hamstrings and quadriceps.
|
15 minutes
|
|
Balance and related fall risks
Tidsramme: 20 minutes
|
Berg Balance Scale and Biodex Balance System will be used to assess balance and related fall risks.
The Berg Balance Scale is a valid and reliable tool to assess populations with gait and balance issues.
By completing 14 assessments with varying multiple tasks, participants will receive a point per task to have a final score which indicate the balance and risk of fall.
Biodex Balance System assesses neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on both static and unstable surface.
These tests will provide a quantified value for fall risk screening and conditioning status.
|
20 minutes
|
|
Bone mineral density
Tidsramme: 8 minutes
|
Bone mineral content and density using regional Dual energy X-ray absorptiometry (DXA) will be measured at regions of lumbar spine (L2-4), proximal femur at the hip joint, and forearm.
T- and Z-scores of each region will be calculated to detect bone mineral density as well as the changes due to the intervention.
|
8 minutes
|
|
Weight measurement
Tidsramme: 1 minute
|
Weight (kg) will be measured using a standard beam scale with height rod.
This anthropometric measurement is used to assess general body size.
Body mass index is calculated and reported.
|
1 minute
|
|
Waist and hip circumferences
Tidsramme: 2 minutes
|
Waist and hip circumference (cm) will be measured using a measuring tape.
These anthropometric measurements are used to assess general body size.
|
2 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Mohamed Abousalem, Ph.D, SJSU
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. januar 2018
Primær fullføring (Faktiske)
1. desember 2021
Studiet fullført (Faktiske)
1. desember 2021
Datoer for studieregistrering
Først innsendt
23. august 2021
Først innsendt som oppfylte QC-kriteriene
27. september 2021
Først lagt ut (Faktiske)
7. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- F17081
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
We understand the importance of data sharing and archiving for our scholarly community and to society at large.
We are willing to share our data as for a significant contribution to the scientific community.
Upon request, we will submit an share our data with public as recommended.
However, as a part of informed consent process and to meet the confidentiality, we will not share any personal information of our research participants
IPD-delingstidsramme
The data will become available 2 years after our manuscripts are published and for additional 3 years.
Tilgangskriterier for IPD-deling
Access to Individual Patient Data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan as well as the execution of a Data Sharing Agreement.
For more information or to submit a request, please contact areum.jensen@sjsu.edu
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Statistisk analyseplan (SAP)
- Informert samtykkeskjema (ICF)
- Klinisk studierapport (CSR)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .