Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients

16. november 2022 opdateret af: Murat Akıncı, Ankara Yildirim Beyazıt University
The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. When we look at the literature on virtual reality applications on balance and walking, it is seen that some systems are beneficial while some systems have no effect. This raises the possibility that virtual reality applications may produce different results due to the task in the exercise, patient motivation or any other reason. There is a need to investigate whether virtual reality applications have different effects, if any, what is the source of this and what care should be taken in the development of these applications in the future. Therefore, we focused on investigating the different effects of Lokomat virtual reality applications.

Studieoversigt

Detaljeret beskrivelse

Stroke is an important health problem worldwide. Emotional, cognitive, sensory and motor problems occur with stroke. Motor problems are especially balance and walking problems and they are related to each other. So balance and gait rehabilitation are primary goals in stroke.

Although the first study to support the efficacy of Lokomat is that Lokomat is superior to conventional physiotherapy in walking, there are also studies reporting that there is no difference between the effects of Lokomat and conventional physiotherapy and that conventional physiotherapy is superior. In the light of all these studies, the effectiveness of applying robotic systems together with conventional physiotherapy is widely accepted.

Robot Assisted Walking Training has many components such as guiding force, walking speed, body weight support. Virtual reality is one of these components and there is literature in which Lokomat virtual reality applications are effective on balance and walking. Although the virtual reality effect is emphasized for Lokomat, there is a lack of literature on the specific effect of different virtual reality applications. In our study, it was aimed to examine the changes caused by different Lokomat virtual reality applications in the spatiotemporal parameters of balance and gait.

Method: This study was conducted to examine the effects of Lokomat VR applications on balance and spatiotemporal parameters of gait in patients with chronic stroke; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 56 individuals with chronic stroke included our study. All individuals have been informed about the study and read and signed the consent form stating that they voluntarily participated in the study. For balance evaluation we used Berg Balance Scale and Huber 360 device, which measures postural stability and limits of stability. And for gait evaluation we used 10 MWT, 6 MWT and spatiotemporal gait analysis for C-Mill VR+.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Ankara, Kalkun, 06000
        • Ankara City Hospital

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

  • Inclusion Criteria:

    • Clinical diagnosis is stroke
    • The time period have to be chronic period (+6 months)
    • The patient must have the ability to walk with or without support
    • The patiens should be able to understand Lokomat exercises
  • Exclusion Criteria:

    • Any condition that may prevent walking with Lokomat
    • Not volunteering to participate in the study

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
Eksperimentel: Lokomat Group I (Endurance)
  • Faster application used with Lokomat gait training
  • Conventional Physiotherapy
  • Faster application (using for Endurance) : 3 days in a week for 6 weeks,very season was 40 min.
  • Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Eksperimentel: Lokomat Group II (Attention and Motivation)
  • Smile and Gabarello applications used with Lokomat gait training
  • Conventional Physiotherapy
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
  • Smile application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min.
  • Gabarello application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min.
  • Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Eksperimentel: Lokomat Group III (Activity Timing)
  • High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training
  • Conventional Physiotherapy
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
  • High Flyer application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 20 min.
  • Treasures application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min.
  • Curve Pursuit application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min.
  • Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Andet: Control
-Only Conventional Physiotherapy
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 6 MWT
Tidsramme: 6 weeks after treatment
6 Minutes Walk Test is a test using for walking distance. We evaluated the change in walking distance with 6 MWT.
6 weeks after treatment
Change in 10 MWT
Tidsramme: 6 weeks after treatment
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
6 weeks after treatment
Change in BBS
Tidsramme: 6 weeks after treatment
Berg Balance Scale used for balance assesment. The scale consists of 14 items and each item gets a score between 0-4. As a result, the person evaluated gets a score between 0-56 on the berg balance scale. A higher score means the person has better balance skills.
6 weeks after treatment
Change in Limits of Stability
Tidsramme: 6 weeks after treatment
Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS. In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step. We used Huber 360 device to evaluate the LoS.
6 weeks after treatment
Change in Spatiotemporal Gait Analysis
Tidsramme: 6 weeks after treatment

Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters.

  • Spatial parameters:

    • Step Length
    • Step Width
    • Stride Length
  • Temporal Parameters

    • Step Time
    • Stride Time
    • Stance Time
    • Swing Time
    • Double Support Time We used C-Mill device to evaluate the spatiotemporal parameters.
6 weeks after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Spatial Symmetry
Tidsramme: 6 weeks after treatment
It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
6 weeks after treatment
Change in Temporal Symmetry
Tidsramme: 6 weeks after treatment
For temporal symmetry we used the description "Gait Symmetry". Gait symmetry is calculated by the ratio of the hemiplegic side sway phase to the hemiplegic side stance phase ratio and the ratio of the non-hemiplegic side sway phase to the non-hemiplegic side stance phase ratio.
6 weeks after treatment
Change in Postural Stability
Tidsramme: 6 weeks after treatment
Postural stability refers to the ability to maintain your body in a position to effectively complete a task or demand, using large muscle groups at the shoulders, trunk, and hips. We used Huber 360 device to evaluate the postural staiblity. The assesments were combination of opened and closed eyes. We recorded the COP vellocity and area.
6 weeks after treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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 (Faktiske)

11. november 2021

Primær færdiggørelse (Faktiske)

1. juni 2022

Studieafslutning (Faktiske)

1. juni 2022

Datoer for studieregistrering

Først indsendt

8. juni 2022

Først indsendt, der opfyldte QC-kriterier

11. juni 2022

Først opslået (Faktiske)

15. juni 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Robot Asisted Gait Training with Lokomat (Endurance)

3
Abonner