- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05244850
The Relationship of Trunk Control With Lower Extremity Sense, Balance and Gait in Stroke
Panoramica dello studio
Descrizione dettagliata
When the literature is examined, it is stated that the best functional results are revealed by a good postural control. Because the trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. It provides trunk control, static and dynamic posture, upright posture of the body, and selective trunk movements. Studies have emphasized the importance of intensive rehabilitation therapy targeting trunk control after stroke. Several randomized controlled trials have looked at the effects of trunk exercises in people with stroke. Saeys and colleagues have shown that the effects of trunk exercises improve standing balance and mobility as well as trunk performance.
There are only a few clinical assessment tools in the literature to evaluate trunk performance. The Trunk Disorder Scale examines static and dynamic sitting balance and trunk coordination. "Postural Assessment Scale for Stroke Patients" (PASS) was developed to evaluate postural control and balance in detail in stroke patients. This scale helps to evaluate postural control and balance of stroke patients, to predict prognosis, to shape treatment, and to observe time-dependent development.
In the literature, the rate of sensory problems accompanying stroke is given differently. In the study conducted by Kim and Choi-Kwon in 67 individuals with acute stroke, two-point discrimination, localization identification, position sense, and stereognosis senses were evaluated and it was found that these senses were affected in 85% of the individuals. In another study, it was stated that sensory impairment in the lower extremities affected gait speed, gait symmetry, standing and walking balance.
However, the relationship between trunk control and lower extremity sense of stroke individuals has not been examined in the literature. In addition, studies on balance and walking have not been sufficiently observed.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Kahramanmaraş, Tacchino
- Kahramanmaraş Sütçü İmam University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Able to walk 10 m without physical assistance,
- Lower extremity functions are in stages 2-6 according to Brunnstrom motor recovery stages,
- At least 3 days and at most 24 months have passed since the stroke,
- Stroke individuals with a score of 7 or higher on the Hodkinson Mental score
Exclusion Criteria:
- Having neurological and orthopedic problems that may affect walking other than stroke,
- Having a history of cardiovascular and rheumatological diseases that prevent daily activities,
- Lesion or fracture in the lower extremity,
- Lower extremity spasticity 4 according to the modified Ashworth Scale,
- Individuals with aphasia and communication disorders
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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One group
Stroke patients
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Misure
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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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Trunk Impairment Scale
Lasso di tempo: At baseline
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The Trunk Impairment Scale consists of 3 subscales: static sitting balance (3 items), dynamic sitting balance (10 items) and coordination (4 items).
The maximum score of the owner is 7, 10 and 6 points respectively.
The Total Trunk Impairment Scale score ranges from 0 to 23, with higher scores indicating better trunk control.
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At baseline
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Tinetti Balance and Gait Test
Lasso di tempo: At baseline
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It consists of two parts, walking and balance.
Consisting of 16 questions in total, the scale consists of 9 questions in which balance is evaluated first, followed by 7 questions in which gait is evaluated.
The total score obtained by the evaluated participant from the first 9 questions constitutes the balance score, and the total score obtained from the following 7 questions constitutes the walking score. 2 points means that the requested task was done correctly, 1 point means that the task was done with adaptations, and 0 points means that the desired task could not be done.
A total test score of 18 or less indicates a high fall risk, a moderate fall risk of 19-24 points, and a low-level fall risk with a score above 24.
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At baseline
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Ten Meter Walking Test
Lasso di tempo: At baseline
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During the test, the patient walks at a normal walking pace for a distance of 10 meters and the time is recorded.
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At baseline
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Fugl Mayer Assesment of Sensorimotor Function
Lasso di tempo: At baseline
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The sensory subscale of FMA (FMA-S) consists of 12 sub-parameters; 4 items are for light touch and 8 items are for proprioception sense.
Scoring is between 0-24 points.
The light touch sensation is subjectively tested.
Joint position is tested on the thumb, wrist, elbow, and interphalangeal joint of the glenohumeral joint.
Position sense of the lower extremities is tested on the toe, ankle, knee and hip joint.
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At baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Turkish version of Postural Assessment Scale for Stroke Patients (PASS-T)
Lasso di tempo: At baseline
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PASS is a special scale used to measure balance even in stroke patients with very low physical performance.
The PASS includes 12 items that measure a person's balance performance in situations where the degree of difficulty is different, that is, when changing positions while lying, sitting, standing or standing.
The scale is evaluated between 0-36.
Between 0-3, the feasibility of the movement is tested; "0" is the lowest; "3" is the highest value.
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At baseline
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Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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