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The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy

31. januar 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Jose, California, Forenede Stater, 95192
        • San Jose State University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Resistance/strength training
Adfærdsmæssigt: Exercise training
Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

San Jose State University

Efterforskere

  • Studieleder: Mohamed Abousalem, Ph.D, SJSU

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. januar 2018

Primær færdiggørelse (Faktiske)

1. december 2021

Studieafslutning (Faktiske)

1. december 2021

Datoer for studieregistrering

Først indsendt

23. august 2021

Først indsendt, der opfyldte QC-kriterier

27. september 2021

Først opslået (Faktiske)

7. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F17081

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)
  • Klinisk undersøgelsesrapport (CSR)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cerebral Parese

Kliniske forsøg med Exercise training

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