- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02836587
The Influence of Balance Training on Postural Control in Elderly
19. september 2017 opdateret af: Zdenek Svoboda, Palacky University
Fall related injuries are major health problem which effect especially elderly population.
After experiencing a fall, most of the elderly are unable to resume their previous mobility and the fear of future falls affects their daily life.
Falls in elderly population are often related to balance or gait problems.
The aim of this study is to assess the influence of balance training on postural and motor control of healthy elderly participants.
The study is designed as a parallel interventional study with experimental and control group (allocation ratio 1:1).
Participants' general health, balance abilities, fear of falling and gait stability and variability will be assessed on the baseline measurement, right after and 2 months after the completion of the training programme.
Experimental group will undergo training focused on development of balance abilities and strength twice a week (60 minutes in length each) for 8 weeks.
Participants will receive individualized exercises which will be focused on the main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of lower extremities.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Olomouc, Tjekkiet, 77111
- Faculty of Physical Culture, Palacky University Olomouc
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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
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age 60+
- ability to stand and walk without aid or support
- participation in the institutional program "Falls risk and balance assessment" with successful completion of one year of observation for falls
Exclusion Criteria:
- neuromuscular or orthopaedic impairments that severely limit mobility and balance
- surgery or injury on the musculoskeletal system less than 2 years before baseline measurement
- any acute illness
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: interventional
Experimental group will undergo balance training for 8 weeks.
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The interventional program will last 8 weeks with the intensity of two 60-minutes lectures a week.
Training sessions will be delivered by a physiotherapist to small groups of patients (3-5).
Participants will receive individualized exercises which will be focused on main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of the lower extremities.
The difficulty level will be increased progressively after participant's ability to complete each exercise independently (e.g.
eyes closed, exercises on balance equipment - wobble board, foam etc., addition of a secondary cognitive task).
The training session will consist of a ten-minute warm-up followed by five-minute stretching, 30 minutes of balance training and 15 minutes of stretching and relaxation.
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Ingen indgriben: control
Control group will have no assigned intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change from baseline Berg balance scale score after completing intervention
Tidsramme: 2 months
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2 months
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Change from baseline mean velocity of centre of pressure during quiet stance after completing intervention
Tidsramme: 2 months
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2 months
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Change from baseline stride time variability after completing intervention
Tidsramme: 2 months
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2 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Change from baseline Falls efficacy scale - International score after completing intervention
Tidsramme: 2 months
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2 months
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Change from baseline gait velocity after completing intervention
Tidsramme: 2 months
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2 months
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Change from baseline short-term Lyapunov exponents after completing intervention
Tidsramme: 2 months
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2 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Zdenek Svoboda, Ph.D., Faculty of Physical Culture, Palacky University Olomouc
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
1. september 2016
Primær færdiggørelse (Faktiske)
16. juli 2017
Studieafslutning (Faktiske)
19. september 2017
Datoer for studieregistrering
Først indsendt
7. juni 2016
Først indsendt, der opfyldte QC-kriterier
14. juli 2016
Først opslået (Skøn)
19. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UPOL_FTK_001
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 .
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