- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05114044
The Effects of Core Stability Training in Chronic Stroke Patients
29 ottobre 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ankara, Tacchino
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline score of Berg Balance Scale at week 3
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 giugno 2019
Completamento primario (Effettivo)
1 ottobre 2021
Completamento dello studio (Effettivo)
1 ottobre 2021
Date di iscrizione allo studio
Primo inviato
20 ottobre 2021
Primo inviato che soddisfa i criteri di controllo qualità
29 ottobre 2021
Primo Inserito (Effettivo)
9 novembre 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 novembre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 ottobre 2021
Ultimo verificato
1 ottobre 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 23 (SIME)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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