Clinical trial NCT05083195: The Effect of Home-Based Telerehabilitation in Individuals With Stroke
Official title: The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Telerehabilitation
Home-based
Physiotherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.

In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with stroke at least 1 year ago by a neurologist
* Modified Rankin score ≤3
* Have an internet infrastructure that can be accessed at home
* Not participated in a standardized physiotherapy program in the past 3 months

Exclusion Criteria:

* Presence of blurred or low vision problems
* Hearing and speech impairment at a level that will affect participation in the system
* Epilepsy
* Presence of pregnancy
* Having any cognitive problems that prevent using the system

Primary outcomes:
measure: Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
Secondary outcomes:
measure: Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
timeFrame: Baseline and end of weeks 8
measure: Global Rating of Change Scales
timeFrame: End of weeks 8
measure: System Usability Scale
timeFrame: End of weeks 8
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakirkoy
Study officials:
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Recep Ormen, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpasa Faculty of Health Science
name: Yonca Zenginler Yazgan, PhD
role: STUDY_CHAIR
References: