- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05114044
The Effects of Core Stability Training in Chronic Stroke Patients
29. oktober 2021 opdateret af: Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
The Effects of Core Stability Training on Functional Ability and Muscle Thickness in Chronic Stroke Patients
The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
After being informed about the study all the patients giving written informed consent were assessed.
At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group.
The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks.
Patients were assessed twice: before and after treatment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ankara, Kalkun
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- First onset
- Stroke duration from 6 months to 2 years
- With ability to cooperate
- Independent ambulation or ambulation with assistive device
Exclusion Criteria:
- Uncooperative
- Neglect syndrome
- Surgical history of abdominal and hip region
- Drugs that affect neuromuscular control
- Other neurological disorders
- Serious diseases, unstable medical condition
- BMI ≥ 35
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Core stability group
Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks.
The therapy session takes 45 min; 15 min of the session was core stability training, remaining 30 min were conventional therapy.
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The core stability training were performed 5 days a week for 15 min over a period of 3 weeks.
The conventional therapy were performed 5 days a week for 30 min (remaining time of each session) over a period of 3 weeks.
Duration of each session was 45 min.
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Aktiv komparator: Conventional therapy group
Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks.
The therapy session takes 45 min of conventional therapy.
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The conventional therapy were performed 5 days a week for 45 min over a period of 3 weeks.
Duration of each session was 45 min
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline score of Berg Balance Scale at week 3
Tidsramme: Baseline and week 3 (after treatment)
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Berg Balance Scale is reliable and valid tool to assess balance and functional mobility.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
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Baseline and week 3 (after treatment)
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Change from baseline score of Motricity Index Scale for lower extremity at week 3
Tidsramme: Baseline and week 3 (after treatment)
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The Motricity Index was used to measure strength in upper and lower extremities after stroke.
Assessing lower extremity strength is a 3 item list with each item consisting of a six point scale ranging from 0 to 33 (0, 9, 14, 19, 25, 33).
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Baseline and week 3 (after treatment)
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Change from baseline score of Trunk Control Test at week 3
Tidsramme: Baseline and week 3 (after treatment)
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Trunk Control Test assess four simple aspect of trunk movement.
Total score range: 0 to 100.
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Baseline and week 3 (after treatment)
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Change from baseline score of 6 Minute Walk Test (6MWT) at week 3
Tidsramme: Baseline and week 3 (after treatment)
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6MWT is valid and reliable test to assess walking capacity of stroke patients.
The distance that a patient can walk within six minutes is evaluated.
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Baseline and week 3 (after treatment)
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Change from baseline score of Functional Independence Measure (FIM) at week 3
Tidsramme: Baseline and week 3 (after treatment)
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FIM is valid and reliable scale to assess and grade the functional status of a person based on the level of assistance he or she requires.
FIM is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
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Baseline and week 3 (after treatment)
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Change from baseline score of Trunk Impairment Scale (TIS) at week 3
Tidsramme: Baseline and week 3 (after treatment)
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TIS is a tool to assess static and dynamic sitting balance and trunk coordination in a sitting position.
On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
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Baseline and week 3 (after treatment)
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Change from baseline score of Timed Up and Go Test (TUG) at week 3
Tidsramme: Baseline and week 3 (after treatment)
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TUG test is an assessment tool for measuring mobility in stroke patients.
The TUG times a patient standing from a chair, walking 3 metres and returning to sit down.
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Baseline and week 3 (after treatment)
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Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3
Tidsramme: Baseline and week 3 (after treatment)
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SS-QOL is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Patients must respond to each question of the SS-QOL with reference to the past week.
It is a self-report scale containing 49 items.
Items are rated on a 5-point Likert scale.
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Baseline and week 3 (after treatment)
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Change from baseline measurements Core muscle thickness at week 3
Tidsramme: Baseline and week 3 (after treatment)
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Thickness of five core muscles (rectus abdominis, external oblique, internal oblique, transversus abdominis, multifidus and gluteus medius) are measured by ultrasound.
Paretic and nonparetic side of each patient are assessed twice (at baseline and after treatment).
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Baseline and week 3 (after treatment)
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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)
19. juni 2019
Primær færdiggørelse (Faktiske)
1. oktober 2021
Studieafslutning (Faktiske)
1. oktober 2021
Datoer for studieregistrering
Først indsendt
20. oktober 2021
Først indsendt, der opfyldte QC-kriterier
29. oktober 2021
Først opslået (Faktiske)
9. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. oktober 2021
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23 (SIME)
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