- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07598487
Comparative Effects of PNF (Rhythmic Stabilization With Stabilizing Reversal) and NDT (Facilitatory Techniques) on Trunk Control in Sub-Acute Stroke
A stroke is a serious cerebrovascular accident defined as the sudden onset of a neurological deficit caused by vascular changes. Stroke are classified into primarily two types; ischemic and hemorrhagic stroke. In an ischemic stroke, there is an inadequate blood supply to the central nervous system, whereas a hemorrhagic stroke involves a blood vessel rupture and subsequent blood accumulation. Stroke is the fifth leading cause of death and primary cause of severe disability. In hemiplegic patient, trunk impairment is frequently present due to muscular weakness. Furthermore, it can lead to severe functional impairments and reduce a patient's quality of life. Severe complications will occur, if left untreated these complications can lead to functional dependency. Trunk muscular activity is delayed in stroke patient, muscles involved in reaching activity of upper limb activates earlier than the trunk muscles themselves. Trunk muscles play a unique role in maintaining upright posture during sitting, standing and they are important for stabilizing proximal body parts during voluntary limb movements. Patients with hemiparesis often struggle to move their trunk against gravity, regardless of the specific muscle activity required.
Different treatment approaches are used to manage trunk stability in stroke patients with Proprioceptive Neuromuscular Facilitation and Neurodevelopmental Facilitatory Techniques being two of the most common techniques in neurorehabilitation. Proprioceptive Neuromuscular Facilitation technique (PNF) is a well- established approach used to improve functional movement through facilitation, strengthening and lengthening of muscle groups. Neurodevelopmental treatment focuses on the patient's active participation to improve motor control. The aim of this study is to compare the effects of PNF (Rhythmic Stabilization with Stabilizing Reversal) and NDT (Facilitatory Techniques) on trunk control in subacute stroke patients. Thirty- two participants having age 40-65years, hemiparesis, Middle Cerebral Artery Stroke will be included. Patients with recurrent stroke, impaired cognition, severe cerebellar ataxia, severe language deficit and severe musculoskeletal disorders will be excluded.
Electrical stimulation will be given as a baseline treatment for 10-15 minutes on hemiparesis side. Group A will receive PNF facilitation along with the baseline
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treatment. Group B will receive Neurodevelopmental facilitation techniques in addition to the baseline treatment. Specific clinical tools will be used to assess trunk mobility in stroke survivors. Trunk Impairment Scale (TIS) will be used to evaluate motor rearrangement and provide clinicians with information regarding the quality of trunk movements and stability. Modified Functional Reach Test (MFRT) is reliable test for stroke survivors with impaired trunk mobility. It will be used to evaluate the participants ability to maintain dynamic sitting balance. Data will be analyzed using SPSS (2023 version). Statistical test will be selected based on data normality. If the data will be normally distributed, independent and paired t- test will be applied. If data will be not normal, then Wilcoxon Signed Rank and Mann Whitney U test will be utilized.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Faisalabad, Punjab Province, Pákistán, 38000
- Madinah Teaching Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Both males and females will be eligible for this study. Patient diagnosed with an ischemic stroke involving the Middle Cerebral Artery resulting in hemiparesis will be included. Participants with significant trunk instability, defined by a score of less than 21 on the Trunk Impairment Scale will be included.
Exclusion Criteria:
Those presenting with recurrent stroke and severe cardiovascular instability will be excluded from the study.
Patients with co-existing neurological disorders or severe cerebellar lesion will be excluded from the study.
Individuals with significant cognitive deficit or language impairments that hinder the ability to follow simple instructions will be excluded from the study.
Patients with severe pre-existing musculoskeletal pathologies will be excluded from the study.
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Group A PNF (Rhythmic Stabilization with Stabilizing Reversal techniques)
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Baseline: Electrical Muscle Stimulation for a duration of 10-15 minutes Group A-Proprioceptive Neuromuscular Facilitation (PNF) Participants will receive baseline treatment combined with particular proprioceptive neuromuscular facilitation techniques, including Rhythmic Stabilization and Stabilizing Reversal.
Both techniques are known to engage deep trunk muscles, which contributes to symmetrical movement pattern and better postural control.
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Experimentální: Group B NDT (Facilitatory Techniques)
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Group B will be treated with baseline EMS for a duration of 10-15 minutes.
alongside various facilitatory techniques designed to restore trunk function.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Trunk control
Časové okno: 8 weeks
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Trunk impairment scale (TIS) is a highly trusted clinical resource used to measure core stability in stroke survivors, especially during the vital subacute stroke recovery period.
This tool breaks down core function into three key areas; how well a patient sit still, how they move while seated and how coordinated their torso is.
Since, core strength is the foundation for almost every movement (from sitting upright to (walking) a low score on the TIS often highlights why a patient might struggle with mobility and balance.
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8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Modified Functional Reach Test (MFRT)
Časové okno: 8 weeks
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Modified Functional Reach Test (MFRT) is reliable test for stroke survivors with impaired trunk mobility.
It will be used to evaluate the participants ability to maintain dynamic sitting balance and trunk control.
While based on the original Functional Reach Test, the MFRT is specifically adapted for patients who lack the ability to stand unaided.
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8 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- TUF/EIRB/167/26
Informace o lécích a zařízeních, studijní dokumenty
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