- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07754747
Effects of Vestibular-Oriented Balance Training Versus Motor Dual Task Training on Balance, Postural Control, and Fall Risk in Chronic Stroke Survivors
Effects of Vestibular-Oriented Balance Training Versus Motor Dual Task Training on Balance, Postural Control, and Fall Risk in Chronic Stroke SurvivorsIIUI/RERC
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Stroke is one of the leading causes of long-term disability worldwide and is associated with significant impairments in balance, postural control, mobility, and functional independence. Balance dysfunction remains one of the most challenging complications in chronic stroke survivors despite conventional rehabilitation interventions.
Vestibular-Oriented Balance Training (VOBT) is an evidence-based rehabilitation approach designed to improve balance by stimulating the vestibular system and enhancing sensory integration. This intervention includes exercises involving head movements, gaze stabilization, balance challenges on stable and unstable surfaces, dynamic postural tasks, and coordinated body movements.
Although both Vestibular-Oriented Balance Training and Motor Dual Task Training have demonstrated beneficial effects individually, there is limited high-quality evidence directly comparing their effectiveness in improving balance, postural control, and fall risk among chronic stroke survivors. Identifying the more effective rehabilitation strategy would assist physiotherapists in selecting evidence-based interventions that optimize patient recovery and functional independence.
The present study is designed as a randomized controlled trial to compare the effects of Vestibular-Oriented Balance Training and Motor Dual Task Training on balance, postural control, and fall risk in individuals with chronic stroke. A total of 50 eligible participants diagnosed with chronic stroke will be recruited using predefined inclusion and exclusion criteria. Participants will be randomly allocated into two parallel intervention groups using a computer-generated randomization sequence.
Participants allocated to the experimental group will receive Vestibular-Oriented Balance Training in addition to conventional physiotherapy. The intervention will consist of progressive vestibular exercises including gaze stabilization, head movement exercises, balance training on different support surfaces, weight-shifting activities, dynamic standing balance tasks, reaching activities, stepping exercises, and functional gait activities. The intensity and difficulty of the exercises will be progressively increased according to each participant's performance and tolerance throughout the intervention period.
Participants allocated to the active comparator group will receive Motor Dual Task Training together with the same conventional physiotherapy program. The intervention will include simultaneous performance of balance and mobility tasks combined with functional motor activities such as walking while carrying objects, obstacle negotiation, reaching during standing, stepping while manipulating objects, and other progressively challenging motor dual-task exercises. Exercise progression will be individualized according to participant performance to ensure safety and maximize functional improvement.
Both groups will receive intervention sessions three times per week for five consecutive weeks. Each treatment session will last approximately 45 to 60 minutes. Conventional physiotherapy will be standardized across both groups to ensure that the only difference between groups is the assigned experimental intervention.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hafsah Arshad, PhD*
- Telefonní číslo: 03315165234
- E-mail: hafsah.arshad@uipt.iiui.edu.pk
Studijní záloha kontaktů
- Jméno: Ijaz Ahmed, MS-NMPT
- Telefonní číslo: +923437149637
- E-mail: ejaza788@gmail.com
Studijní místa
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-
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Rawalpindi, Pákistán, 46000
- Nábor
- Armed Forces Institute of Rehabilitation Medicine Rawalpindi, Pakistan
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Kontakt:
- Ijaz Ahmed, MS-NMPT
- Telefonní číslo: +923437149637
- E-mail: ejaza788@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Diagnosis of ischemic stroke.
- Stroke duration ≥6 months.
- Rhomberg scale
- MMSE ≥ 24
- Able to walk with or without assistive device.
- Able to understand commands
- Willing to participate and provide consent aged between 40-70 years.
Exclusion Criteria:
- Severe visual impairements which effect balance.
- Participants with acute or sub acute stroke <6 moths.
- Uncontrolled hypertension
- Uncontrolled diabetes
- Other neurological disorders such as Parkinson's disease or multiple sclerosis and Alzheimer's
- Participation in any other interventional trail.
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 |
|---|---|
|
Experimentální: Vestibular-Oriented Balance Training
Participants will receive vestibular-oriented balance exercises together with conventional physiotherapy for five weeks
|
Participants will receive vestibular-oriented balance exercises together with conventional physiotherapy for five weeks
|
|
Aktivní komparátor: Motor Dual Task Training
Participants will receive motor dual-task balance training together with conventional physiotherapy for five weeks
|
Participants will receive motor dual-task balance training together with conventional physiotherapy for five weeks.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Biodex Over all stability Index
Časové okno: assessment at baseline and after 6 weeks
|
Overall Stability Index (OSI) on the Biodex Balance System is a comprehensive score measuring how well a person controls their balance and keeps a moving platform level.
Higher numbers mean more platform tilt and poorer balance control, while lower numbers show better stability and stronger neuromuscular coordination.
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assessment at baseline and after 6 weeks
|
|
Biodex Fall Risk index
Časové okno: at baseline and after 6 weeks
|
It measures a person's stability and risk of falling by tracking how much they sway on a moveable balance platform.
Higher scores indicate poor stability and a higher likelihood of falls
|
at baseline and after 6 weeks
|
|
Modified clinical test of sensory interaction on balance
Časové okno: at baseline and after 6 weeks
|
a clinical tool used to evaluate static postural control and identify which sensory systems (vision, vestibular, or somatosensory/proprioceptive) a patient relies on or struggles with to maintain balance.
|
at baseline and after 6 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Biodex APSI
Časové okno: at baseline and after 6 weeks
|
Anterior/Posterior Stability Index (APSI) on the Biodex Balance System measures front-to-back postural sway and balance ability.
Higher scores indicate greater platform displacement and poorer stability, while lower scores reflect better front-to-back neuromuscular control and stability.
|
at baseline and after 6 weeks
|
|
Biodex Medial/Lateral Stability Index
Časové okno: at baseline and after 6 weeks
|
A lower score indicates better stability, meaning the person stayed closer to the center level.
A higher score represents greater side-to-side sway, indicating poor postural performance or a higher risk of falling.
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at baseline and after 6 weeks
|
Spolupracovníci a vyšetřovatelé
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
Klíčová slova
Další relevantní podmínky MeSH
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