- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06657989
Optimal intensitet af reaktiv balancetræning for raske ældre voksne
Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Avril Mansfield, PhD
- Telefonnummer: 7831 416-597-3422
- E-mail: avril.mansfield@uhn.ca
Undersøgelse Kontakt Backup
- Navn: David Jagroop
- Telefonnummer: 7614 416-597-3422
- E-mail: david.jagroop@uhn.ca
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2A2
- Rekruttering
- University Health Network
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Kontakt:
- David Jagroop
- Telefonnummer: 7614 416-597-3422
- E-mail: david.jagroop@uhn.ca
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Community-dwelling older adults (65-80 years old)
Exclusion Criteria:
- Unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
- Score below normative values on the Montreal Cognitive Assessment;
- Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
- Have insufficient English language comprehension such that they cannot understand instructions;
- Have contraindications to reactive balance training such as severe osteoporosis; and/or
- Are currently attending physiotherapy or supervised exercise.
Studieplan
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: High intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 3 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
Andre navne:
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Aktiv komparator: Moderate intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to moderate-intensity RBT will experience perturbations at 100% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 2 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
Andre navne:
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Sham-komparator: Walking control group
Participants assigned to the walking control group will complete 36 trials of unperturbed walking in each training session. |
Overground walking |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of reactive steps
Tidsramme: Two weeks
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Learning rate for number of steps to recover from 'backward fall' balance perturbations |
Two weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Step initiation time
Tidsramme: One week and 12 weeks post-training
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Time from perturbation onset time to foot off time |
One week and 12 weeks post-training
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Step execution time
Tidsramme: One week and 12 weeks post-training
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Time from foot off to foot contact of the first step |
One week and 12 weeks post-training
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Step length
Tidsramme: One week and 12 weeks post-training
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Difference in foot position from foot off to foot contact |
One week and 12 weeks post-training
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Braking impulse
Tidsramme: One week and 12 weeks post-training
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Antero-posterior shear force generated over time on step contact |
One week and 12 weeks post-training
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Mechanical margin of stability
Tidsramme: One week and 12 weeks post-training
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Distance between the extrapolated centre of mass (incorporating centre of mass position and velocity) and the edge of the base of support |
One week and 12 weeks post-training
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Balance evaluation systems test
Tidsramme: One week and 12 weeks post-training
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Scale ranges from 0-100, with higher scores indicating better outcome |
One week and 12 weeks post-training
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Falls efficacy scale - International
Tidsramme: One week, 12 weeks, and 12 months post-training
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Scale range: 10-100; higher values indicate worse outcome |
One week, 12 weeks, and 12 months post-training
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Forekomst af skadelig fald
Tidsramme: 12 måneder efter træning
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12 måneder efter træning
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Antal deltagere med frygt for at falde
Tidsramme: En uge, 12 uger og 12 måneder efter træning
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En uge, 12 uger og 12 måneder efter træning
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Antal deltagere med aktivitetsindskrænkning på grund af frygt for at falde
Tidsramme: En uge, 12 uger og 12 måneder efter træning
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En uge, 12 uger og 12 måneder efter træning
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Fall incidence
Tidsramme: 12 months post-training
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Falls in daily life |
12 months post-training
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5-level EuroQoL health status measure (EQ-5D-5L)
Tidsramme: One week, 12 weeks, and 12 months post-training
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Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome |
One week, 12 weeks, and 12 months post-training
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Avril Mansfield, PhD, University Health Network, Toronto
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24-5665
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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