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Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke

16. november 2020 oppdatert av: Yonsei University

Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.

40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.

Studieoversikt

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Seoul, Korea, Republikken
        • Rekruttering
        • Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
        • Ta kontakt med:
          • Deog Young Kim
          • Telefonnummer: +82-2-2228-3714
          • E-post: KIMDY@yuhs.ac

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. less than 6 months after onset of the stroke
  2. can stand and walk independently 10m
  3. K-MMSE score of at least 15
  4. have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
  5. over 20 years of age.

Exclusion Criteria:

  1. quadriplegia
  2. past history of stroke
  3. past history of Musculoskeletal disease or history of Neurological diseases

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Kontrollgruppe
The control group received the usual gait training.
Eksperimentell: Treningsgruppe

The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK).

Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side.

On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value.

It is designed to induce the maximum weight shift through the archery game.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Step Length Asymmetric Ratio
Tidsramme: before training(0week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
before training(0week)
Step Length Asymmetric Ratio
Tidsramme: during training(2week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
during training(2week)
Step Length Asymmetric Ratio
Tidsramme: after training(4week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
after training(4week)
Step Length Asymmetric Ratio
Tidsramme: Follow up(8week)
Step Length Asymmetric Ratio = paretic step length/non paretic step length
Follow up(8week)
Step Length Asymmetric Index
Tidsramme: before training(0week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
before training(0week)
Step Length Asymmetric Index
Tidsramme: during training(2week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
during training(2week)
Step Length Asymmetric Index
Tidsramme: after training(4week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
after training(4week)
Step Length Asymmetric Index
Tidsramme: Follow up(8week)
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]
Follow up(8week)

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2014

Primær fullføring (Forventet)

1. juni 2021

Studiet fullført (Forventet)

1. juni 2021

Datoer for studieregistrering

Først innsendt

16. november 2020

Først innsendt som oppfylte QC-kriteriene

16. november 2020

Først lagt ut (Faktiske)

20. november 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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