Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures
16. maj 2016 opdateret af: Bijan Najafi, University of Arizona
Explore the benefit of the game-based virtual reality system in improving lower extremity kinematics and balance in patients suffering from disease/disorders including Diabetes, Cancer, Multiple Sclerosis, Arthritis, Parkinson's disease, Cognitive Disorders, Brain Injury, Stroke or Frailty.
A four to six weeks of training with 2 training session/week will be provided.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Individuals suffering from certain disorders/diseases including diabetes, arthritis, cancer, osteoarthritis, stroke, Parkinson's disease, cognitive impairment or brain Injury are more likely to experience a fall or a fall-related injury than healthy individuals during to impaired postural stability or diminished joint perception.
Under certain circumstance they may also experience pain, depression, anxiety, and a decreased quality of life.
The investigators' research has been designed to provide exercise training using non-invasive body-worn sensors (similar to those used in an iPhone®) to provide real-time visual information about joint motion in a virtual environment.
These sensors will be worn using a vest, t-shirt or elastic band.
The investigators will, 1) assess changes in participant's perception of lower extremity position while they perform these exercises; 2) motivate and guide simple exercise performance in the clinic/home, using an interactive game-like scheme; and 3) assess changes in participant's postural stability and gait as a result of provided exercise training.
The information gathered will provide new understanding about more helpful rehabilitation strategies that improve postural stability in patient population.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
200
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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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- Rekruttering
- University of Arizona
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Kontakt:
- Bijan S Najafi, PhD
- Telefonnummer: 713-798-0477
- E-mail: najafi.bijan@gmail.com
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Diagnosis of:
- diabetes
- cancer
- multiple sclerosis
- arthritis
- Parkinson's disease
- cognitive disorders
- brain injury
- frailty
- stroke
Exclusion Criteria:
- conditions not related to specific disorders affecting balance and gait
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Exergame
inertial sensor based system (wearable sensors, LEGSys, Biosensics LLC) will be used for balance training with computerized feedback.
The balance training program is focused on lower extremities including ankle joint exercise and virtual obstacle crossing tasks.
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Subjects will perform progressive and computerized foot and ankle exercises which include weight shifting, ankle reaching task while standing, and virtual obstacle crossing task (i.e.
balancing on single leg) using wearable sensors technology (Exergaming) equipment).
Subjects will perform these exercises for 4-6 weeks, twice per week.
The duration of exercise per session is anticipated to be 30-45 minutes.
Andre navne:
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Aktiv komparator: Home based balance training
The control group will ask to perform a home based program includes similar exercise components as proposed in the experimental group, however without computerized feedback.
Exercises include postural balance tasks, such as backward and forward weight shifting, as well as dynamic balance exercises, such as marching in place (comparable to virtual obstacle crossing in experimental group).
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Subjects in the control group will ask to perform a standard home based balance program for 4-6 weeks.
The home based program includes similar exercise components as proposed in the experimental group, however without computerized feedback and Exergaming equipment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Balance
Tidsramme: 4-6 weeks
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Balance will be quantified by measuring area of sway of center of mass (with unit of cm2) during quite standing according to Romberg's protocol and using validated instrument (BalanSens, Biosensics, MA, USA)
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4-6 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in gait Speed
Tidsramme: 4-6 weeks
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Gait Speed (with unit of m/sec) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
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4-6 weeks
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Change in Stride length
Tidsramme: 4-6 weeks
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Stride Length (with unit of meter) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
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4-6 weeks
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Change in Stride time
Tidsramme: 4-6 weeks
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Stride time (with unit of second) will be measured using validated wearable technology (LEGSys, Biosensics, MA, USA) and during walking with habitual and fast speed walking
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4-6 weeks
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Change in number of walking steps per day
Tidsramme: 4-6 weeks
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Average of walking steps (no unit) per day will be measured during 48 hours of daily physical activity monitoring using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
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4-6 weeks
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Change in average of walking bout
Tidsramme: 4-6 weeks
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Daily average of walking bout (continuous walking without stop, with unit of steps) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
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4-6 weeks
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Change in average of standing bout
Tidsramme: 4-6 weeks
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Daily average of standing bout (continuous standing without changing in posture with unit of seconds) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
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4-6 weeks
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Change in average of longest walking bout
Tidsramme: 4-6 weeks
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Daily average of longest walking bout (longest continuous walking without stop per day, with unit of steps) will be measured over 48 hours monitoring of physical activity using a validated wearable sensor technology (PAMSys, Biosensics, MA, USA)
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4-6 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 2014
Primær færdiggørelse (Forventet)
1. december 2016
Studieafslutning (Forventet)
1. august 2017
Datoer for studieregistrering
Først indsendt
8. juni 2015
Først indsendt, der opfyldte QC-kriterier
16. maj 2016
Først opslået (Skøn)
19. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Sygdomme i immunsystemet
- Demyeliniserende autoimmune sygdomme, CNS
- Autoimmune sygdomme i nervesystemet
- Demyeliniserende sygdomme
- Autoimmune sygdomme
- Sår og skader
- Neurokognitive lidelser
- Parkinsonlidelser
- Basal Ganglia Sygdomme
- Bevægelsesforstyrrelser
- Synukleinopatier
- Neurodegenerative sygdomme
- Kraniocerebralt traume
- Traumer, nervesystemet
- Multipel sclerose
- Parkinsons sygdom
- Hjerneskader
- Kognitionsforstyrrelser
Andre undersøgelses-id-numre
- 1409482826
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 .