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Home-based Motor Imagery for Gait Stability in Older Adults. A Cross-over Feasibility Study. (MIGS-F) (MIGS-F)

5 agosto 2019 aggiornato da: Roger Hilfiker, University of Applied Sciences of Western Switzerland

Home-based Motor Imagery Intervention for the Improvement of Gait Stability in Elderly Persons. A Cross-over Feasibility Study.

Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in patients with neurological diseases or in healthy elderly persons with exercises.

There is evidence that mental practice, also called motor imagery, the imagination of performing a movement, can also improve an activity or balance. The effective performance and the imagination of a task activates some overlapping central areas and neural networks, which might explain the improvements after motor imagery.

The investigators set out to test the feasibility of such a study using an open label randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to evaluate whether the instructions are clear, the intervention and the study procedures are acceptable and to assess the proportion of participants withdraw from the study (drop outs). Secondary aims are the assessment of between group differences in the changes of the gait stability.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in patients with neurological diseases or in healthy elderly persons with exercises.

There is evidence that mental practice, also called motor imagery, the imagination of performing a movement, can also improve an activity or balance. The effective performance and the imagination of a task activates some overlapping central areas and neural networks, which might explain the improvements after motor imagery.

These "non-physical kind of training" modalities could be used in patients who are immobilized temporarily (bedridden because of non-chronic disease, infection etc.), or in those who are not allowed to charge their leg normally (e.g. postoperative phase of joint replacement or fractures), or it can be used in combination with physical exercises, or in the preparation of the physical exercise training (either skilling up phase or as a preparation to increase safety of physical exercises). In persons above 40 years of age, motor imagery could provide a sound exercise modality for tasks that are not easy to perform with real performance. For example, walking on slippery underground such as ice, walking on a small trail in some altitude, avoiding running dogs or cats on a sidewalk, or catching up after stumbling can be either difficult to exercise in reality or might be too dangerous in reality. Imaging one's performance in such difficult environments or situations might lead to better gait stability, improved reactions in these situations and thus probably to reduced falls frequency.

Gait stability can be estimated with the local dynamic stability, which is based on chaos theory, i.e. the maximal Lyapunov exponent, is strongly influenced by the sensorimotor balance system and is widely used for measuring gait stability.

In the future, the investigators plan a large scale randomized open label cross-over study to test whether nine sessions of motor imagery improve walking stability, measured with the Lyapunov Exponent.

To prepare this future study, the investigators set out to test the feasibility of such a study with a feasibility study using an open label randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to evaluate whether the instructions are clear, the intervention and the study procedures are acceptable and to assess the proportion of participants withdraw from the study (drop outs). Secondary aims are the assessment of between group differences in the changes of the gait stability.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svizzera
    • Valais
      • Leukerbad, Valais, Svizzera, 3954
        • Reclutamento
        • Hochschule für Gesundheit HES-SO Valais-Wallis
        • Contatto:
          • Roger Hilfiker
          • Numero di telefono: 0041796883490

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 40 years old or older
  • Able to walk bout 100 meter, with or without walking aids, but without the help of a person or an ambulator

Exclusion Criteria:

  • Walking with an ambulator (Rollator)
  • No able to understand German

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control
Participants will be allowed to perform all usual activities but should refrain from performing the motor imagery exercises.
Sperimentale: Motor imagery

The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example:

"Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally" The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks.
Altro: Motor imagery

The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example:

"Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally" The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite Endpoint "feasibility"
Lasso di tempo: Immediately after the end of the both Intervention periods (week 6)

Combination of the following three parts:

Part 1: one question about the understandability of the exercises Part 2: one question about the acceptability of the whole study process Part 3: Finishing the whole study: Did the participant finish the whole study, i.e. all three test sessions and at least some session of motor imagery exercises (based on the exercise calendar)?
Immediately after the end of the both Intervention periods (week 6)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence to the motor imagery exercises
Lasso di tempo: Immediately after the end of the first intervention periods (week 3)
The adherence to the motor imagery exercises will be assessed with a exercise calendar with a sheet for each of the three weeks. On each day of the calendar the exercises were shortly described and the participants can just check whether he has done that exercise and can state how many minute he or she has exercises that day (only motor imagery exercises).
Immediately after the end of the first intervention periods (week 3)
Change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical"
Lasso di tempo: Immediately after the end of the first period (week 3)

The "first" endpoint for effectiveness is the change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical". The Lyapunov Exponent is calculated based on the 4 times 30 meter walk test in normal speed.

For these tests, the participants wear normal clothes and normal shoes (same shoes at all three test sessions). The test will be performed in a 35 meter long corridor.

The participant starts walking with his normal speed, walks 30 meters and stops. He turns 180°, waits ten seconds and starts walking again the 30 meters. He repeats this until he has four series of 30 meters. The data will be stored after each participant on a portable computer in coded form. The Lyapunov Exponent is then calculated later in R (statistical software) and the mean over all four series is taken.
Immediately after the end of the first period (week 3)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Applied Sciences of Western Switzerland

Investigatori

  • Investigatore principale: Roger Hilfiker, School of Health Sciences, HES-SO Valais-Wallis

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2016

Completamento primario (Anticipato)

1 giugno 2021

Completamento dello studio (Anticipato)

1 settembre 2021

Date di iscrizione allo studio

Primo inviato

7 febbraio 2016

Primo inviato che soddisfa i criteri di controllo qualità

23 febbraio 2016

Primo Inserito (Stima)

29 febbraio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PHYVS2016-1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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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