- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01547988
Training Improves Balance Control
Improving Balance Control and Self-Reported Lower Extremity Function in Community Dwelling Older Adults - A Randomized Control Study
The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways.
The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- NeuroMuscular Research Center, Boston University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 65 years or older
- Independently ambulatory (cane acceptable; not walker)
- Score better than 45 on the Berg Balance Scale
- Higher than 24 Mini-Mental Score
Exclusion Criteria:
- Severe focal muscle weakness or visual impairment
- Known neurological disorders (including stroke, Parkinson disease)
- Metastatic cancer
- Use of medication that impairs balance or strength
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Balance Training Intervention
The Balance Training Intervention group received 24 training sessions over three months that included perturbation as well as dual-task exercises.
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The intervention group participated in a total of 24 one-hour training sessions over a period of 12 weeks.
The training program utilized different size balls as a general tool in a series of progressively more difficult exercises targeting sitting, standing, and gait-related balance control.
The program included exercises at five different levels of progressively more challenging balance exercises.
Levels 1-4 focused on voluntarily controlled balance exercises, whereas level 5 also included perturbation exercises to trigger automatic compensatory stepping responses.
All levels included attention-demanding dual task exercises that required subjects to simultaneously perform motor and cognitive activities.
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Nessun intervento: Reference Group
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The intervention group participated in a total of 24 one-hour training sessions over a period of 12 weeks.
The training program utilized different size balls as a general tool in a series of progressively more difficult exercises targeting sitting, standing, and gait-related balance control.
The program included exercises at five different levels of progressively more challenging balance exercises.
Levels 1-4 focused on voluntarily controlled balance exercises, whereas level 5 also included perturbation exercises to trigger automatic compensatory stepping responses.
All levels included attention-demanding dual task exercises that required subjects to simultaneously perform motor and cognitive activities.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Reaction time of dual task step execution
Lasso di tempo: 12 weeks
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Subjects stand on a force platform and are asked to execute a step as rapidly as possible following a tactile stimulus on their heel while performing a cognitive attention demanding task (Stroop task - call out colors of words that are names of colors, e.g. the word "BLUE" is presented in yellow letters).
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12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Late Life Functional Disability Index - LLFDI
Lasso di tempo: 12 weeks
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Self-reported measure of function
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12 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lars IE Oddsson, PhD, NeuroMuscular Research Center, Boston University
Pubblicazioni e link utili
Pubblicazioni generali
- Lars I. E. Oddsson, Patrick Boissy and Itshak Melzer. How to improve gait and balance function in elderly individuals-compliance with principles of training. European Review of Aging and Physical Activity Volume 4, Number 1, 15-23, DOI: 10.1007/s11556-007-0019-9
- Melzer I, Oddsson LI. The effect of a cognitive task on voluntary step execution in healthy elderly and young individuals. J Am Geriatr Soc. 2004 Aug;52(8):1255-62. doi: 10.1111/j.1532-5415.2004.52353.x.
- Melzer I, Shtilman I, Rosenblatt N, Oddsson LI. Reliability of voluntary step execution behavior under single and dual task conditions. J Neuroeng Rehabil. 2007 May 29;4:16. doi: 10.1186/1743-0003-4-16.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- RRF 2001-056
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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