Clinical trial NCT06673771: Effects of Vestibular Rehabilitation on Balance and Post Stroke Fatigue :
Official title: Effects of Vestibular Rehabilitation on Balance and Post Stroke Fatigue: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Patients
Keywords: conventional treatment
VRT Treatment
stroke population
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the effects of stroke conventional therapy compared with the effects of vestibular rehabilitation therapy on balance and post stroke fatigue. The study will be randomized control trial including 2 experimental groups with estimated 28 individual in each group

Detailed description: Stroke is the sudden onset of neurological disorders caused by damage to the cerebrovascular arteries. Vascular injury to the brain can be caused by rapid changes in blood pressure and oxygen shortage, resulting in the death of brain cells. Ischemia accounts for 80% of all strokes. Every year, 15 million individuals worldwide suffer from strokes, and five million become permanently disabled. Stroke prevalence is 1.2% in the province of KPK. Over the last 30 years, the burden caused by stroke has significantly increased, and it has become one of the most common causes of mortality globally. . The central nervous system's sensory (visual, vestibular, somatosensory) and motor systems work together to maintain balance. Patients who have had a stroke are more likely to fall than healthy people due to a variety of impairments in motor and cognitive processes. Vestibular dysfunction may potentially cause falls in this patient population due to poor postural control. It has been found that post stroke patients are more prone than healthy controls to lose standing postural stability under vestibular stimulation. Fatigue is a common post stroke consequence, with a prevalence of between 16 to 74% , and it is considered one of the signs of post stroke depression. However, the fact that patients without depression often complain of fatigue needs a study of "post stroke fatigue" (PSF) as a specific syndrome. This type of fatigue is chronic which can be the only symptom in stroke patients even with adequate neurologic recovery and persists for many years .Fatigue constitutes one of the most common symptoms after a stroke and an important predictor for mortality following stroke. PSF correlates with functional limitations and participation limitations in activities of daily living (ADL), leading to a lower quality of life. Vestibular functions requiring central integration correlate more strongly with fatigue, balance, and walking capacity. Stroke patients have shown an improvement in gait performance, balance, and self-perceived health with vestibular rehabilitation. It has been demonstrated that vestibular therapy has greater benefits on gait in stroke patients. Vestibular rehabilitation therapy (VRT) promote gaze stability, improve postural stability and facilitate sensory integration for patients. VRT was found to be beneficial for improving balance in patients with peripheral vestibular impairment. Cawthorne and Cooksey Exercise Program refers to Vestibular Rehabilitation Therapy. They are exercises that gradually train the eye and body muscles to use visual and proprioceptive signals to compensate for missing or disturbed vestibular signals (which cause poor balance and coordination).Gaze stabilization exercises (GSEs), a type of vestibular therapy, including substitution and adaptation exercises that use the vestibulo-ocular reflex (VOR). Substitution exercises are designed to promote different approaches (saccadic eye movement and smooth tracking activities) to compensate for inadequate vestibular function. Adaptation exercises are long-term alterations in the neural response to head motions that aim to reduce symptoms and normalize gaze and postural stability. GSEs can improve the balance function, confidence, and cognition in older adults with mild cognitive dysfunction .VOR gain has a certain effect on the balance and posture of people following stroke. Balance is common consequence among post stroke patients and increase the risk of fall. The central nervous system's sensory (visual, vestibular, somatosensory) and motor systems work together to maintain balance and prevalence of post stroke fatigue is between 16 to 74% which is high and also the Vestibular functions having highly significant relation with fatigue, and balance and limited evidence on vestibular rehabilitation on post stroke fatigue. That's why this study aims to assess the effect of vestibular rehabilitation training on balance and post-stroke fatigue

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with stroke.
* Ability to stand for at least 1 minute without support.
* Fatigue Assessment Scale (FAS) score ≥ 24.
* Willingness to participate

Exclusion Criteria :

* Cognitive Impairment.
* Severe unilateral spatial neglect.
* Severe aphasia.
* Patients who are not willing.

Primary outcomes:
measure: 1. Berg Balance Scale
timeFrame: 8 weeks
measure: Fatigue Assessment Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mānsehra
country: Pakistan
facility: Helping Hand Institute of rehabilitation
state: Khyber Pakhtunkhuwa
Study officials:
affiliation: Riphah International University
name: Nadia Azhar MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: