- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04637737
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
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
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken
- Rekruttering
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
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Ta kontakt med:
- Deog Young Kim
- Telefonnummer: +82-2-2228-3714
- E-post: KIMDY@yuhs.ac
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- less than 6 months after onset of the stroke
- can stand and walk independently 10m
- K-MMSE score of at least 15
- have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
- over 20 years of age.
Exclusion Criteria:
- quadriplegia
- past history of stroke
- past history of Musculoskeletal disease or history of Neurological diseases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: Kontrollgruppe
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The control group received the usual gait training.
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Eksperimentell: Treningsgruppe
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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 |
|---|---|---|
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Step Length Asymmetric Ratio
Tidsramme: before training(0week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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before training(0week)
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Step Length Asymmetric Ratio
Tidsramme: during training(2week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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during training(2week)
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Step Length Asymmetric Ratio
Tidsramme: after training(4week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
|
after training(4week)
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Step Length Asymmetric Ratio
Tidsramme: Follow up(8week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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Follow up(8week)
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Step Length Asymmetric Index
Tidsramme: before training(0week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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before training(0week)
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Step Length Asymmetric Index
Tidsramme: during training(2week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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during training(2week)
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Step Length Asymmetric Index
Tidsramme: after training(4week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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after training(4week)
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Step Length Asymmetric Index
Tidsramme: Follow up(8week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
|
Follow up(8week)
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4-2014-0383
Plan for individuelle deltakerdata (IPD)
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