NCT05083195

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 8, 2021

Last Update Submit

October 8, 2021

Conditions

Stroke

Keywords

TelerehabilitationHome-basedPhysiotherapy

Outcome Measures

Primary Outcomes (5)

  • Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)

    It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.

    Baseline and end of weeks 8

  • Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)

    This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.

    Baseline and end of weeks 8

  • Romberg Test (The change between the initial value and the value after 2 months will be evaluated)

    The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.

    Baseline and end of weeks 8

  • Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)

    It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.

    Baseline and end of weeks 8

  • Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)

    It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.

    Baseline and end of weeks 8

Secondary Outcomes (5)

  • Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)

    Baseline and end of weeks 8

  • WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)

    Baseline and end of weeks 8

  • Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)

    Baseline and end of weeks 8

  • Global Rating of Change Scales

    End of weeks 8

  • System Usability Scale

    End of weeks 8

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.

Other: Home-based Telerehabilitation

Control Group

EXPERIMENTAL

This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.

Other: Exercise Brochure

Interventions

Home-based TelerehabilitationOTHER

Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.

Telerehabilitation Group
Exercise BrochureOTHER

Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.

Control Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakirkoy, 34100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Recep Ormen, M.Sc

    Istanbul University-Cerrahpasa Institute of Postgraduate Education

    PRINCIPAL INVESTIGATOR

  • Yonca Zenginler Yazgan, PhD

    Istanbul University-Cerrahpasa Faculty of Health Science

    STUDY CHAIR

Central Study Contacts

Recep Ormen, M.Sc

CONTACT

+905316777334rormen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 19, 2021

Study Start

October 4, 2021

Primary Completion

August 4, 2022

Study Completion

December 28, 2022

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

TU(1)