- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04985162
Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Ischemic stroke is still the second most common cause of death and one of the leading causes of disability worldwide. Half of all individuals with ischemic stroke do not regain lost body functions until the end of life. Individuals with ischemic stroke are most likely to have impaired cognitive, sensory, and motor functions, but the greatest challenge for health care professionals is impaired motor skills caused by motor nerve cell damage. In order to minimize the degree of disability, it is important to respond quickly to a person's condition. Because it has been shown that lost functions can be taken over by adjacent, non-stroke-affected areas of the cerebral cortex, early rehabilitation is a key factor that can help prevent function limitation by acting in conjunction with spontaneous recovery of body function.
The aim of the study is to assess the effect or ordinary and differential learning based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the second phase of rehabilitation.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-KN(B)-263).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Kaunas, Litauen
- Lithuanian University of Health Sciences, Department of Rehabilitation
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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:
- Patients rehabilitated in Neurorabilitation Departmen of Lithuanian University of Health sciences hospital Kauno Kliniko in the second stage of rehabilitation;
- Stroke for the first time;
- 45-74 m. age;
- Able to go with aids;
- Voluntary consent to participate in the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervention
Intervention group (n=10) received differential learning based physiotherapy program: 3 times a week ordinary physiotherapy, 2 times a week differential learning based on physiotherapy, total 3 weeks
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Differential learning based physiotherapy to improve torso control, balance and gait
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Aktiv komparator: Control
Control group (n=10) received ordinary physiotherapy program 5 times a week, total 3 weeks
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Ordinary physiotherapy program
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Torso control assessment scale
Tidsramme: Baseline to 3 weeks
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The torso control rating scale evaluates torso functions in a variety of locations, whether standing, sitting or performing a mobility assessment task.
Each task was scored from 0 to 3 points: 0 - cannot perform task, 3 - can perfom task independently.
Total test score is 36 and a higher total score meant a better trunk function.
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Baseline to 3 weeks
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Berg balance test
Tidsramme: Baseline to 3 weeks
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The Berg scale is used to assess a subject's static and dynamic balance.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. The maximum obtainable score is 56.
0 points -are awarded to answers portraying the lowest level of function while 4 points are awarded to the highest level of function.
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Baseline to 3 weeks
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Dynamic gait index is used to assess the likelihood of falling. A four-point ordinal scale, ranging from 0-3 points. Total maximum score is 24 points. 0 points indicates the lowest level of function and 3 points - the highest level of function.
Tidsramme: Baseline to 3 weeks
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Dynamic gait index assessed the gait model, provided information about the person's balance while walking
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Baseline to 3 weeks
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- 002 (University of CT Health Center)
Plan for individuelle deltakerdata (IPD)
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