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- Klinische proef NCT06657989
Optimale intensiteit van reactieve evenwichtstraining voor gezonde oudere volwassenen
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Avril Mansfield, PhD
- Telefoonnummer: 7831 416-597-3422
- E-mail: avril.mansfield@uhn.ca
Studie Contact Back-up
- Naam: David Jagroop
- Telefoonnummer: 7614 416-597-3422
- E-mail: david.jagroop@uhn.ca
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5G 2A2
- Werving
- University Health Network
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Contact:
- David Jagroop
- Telefoonnummer: 7614 416-597-3422
- E-mail: david.jagroop@uhn.ca
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Actieve vergelijker: 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.
Andere namen:
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Sham-vergelijker: Walking control group
Participants assigned to the walking control group will complete 36 trials of unperturbed walking in each training session. |
Overground walking |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of reactive steps
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Step initiation time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Schadelijke valincidentie
Tijdsspanne: 12 maanden na de training
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12 maanden na de training
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Aantal deelnemers met valangst
Tijdsspanne: Eén week, twaalf weken en twaalf maanden na de training
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Eén week, twaalf weken en twaalf maanden na de training
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Aantal deelnemers met activiteitsbeperking vanwege valangst
Tijdsspanne: Eén week, twaalf weken en twaalf maanden na de training
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Eén week, twaalf weken en twaalf maanden na de training
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Fall incidence
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Avril Mansfield, PhD, University Health Network, Toronto
Studie record data
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Studie voltooiing (Geschat)
Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 24-5665
Plan Individuele Deelnemersgegevens (IPD)
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