Development and Application of Tele-Neuro Rehabilitation System

NCT05031403 | Unknown

• 1 other identifier: 120S843
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Disability due to neurological diseases is increasing in our country and world. With regular physiotherapy and rehabilitation, as well as patients' symptoms are brought under control, their affected functions in daily life are achieved and levels of independence and physical activity increase. Thus, the patients' quality of life and participation in social life is improved and patients are supported in physical, social and psychological terms. In recent years, it has been reported that exercise with telerehabilitation systems increase the compliance and participation of patients to the treatment, and even this system seems as effective as standard rehabilitation practices. Delivering the treatment through telerehabilitation system when that patients cannot receive it in the hospital due to epidemic, restriction, transfer difficulties, personal and environmental limitations will enable patients to receive the rehabilitation services.Telerehabilitation system is frequently encountered in the abroad, but there are limited systems with Turkish version specific to this patient group in our country. The aim of project is to develop and detect the efficiency of a telerehabilitation system which is used to assess, follow and design home-based rehabilitation program among individuals with chronic neurological diseases who have difficulty in participating in physiotherapy and rehabilitation services because of personal or environmental reasons.

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease

Keywords

E-Health; Web Based Systems; Neurologic Rehabilitation; Neurorehabilitation; Physical Therapy and Rehabilitation; Stroke Rehabilitation; Multiple Sclerosis; Parkinson's Disease; Data Storage; Stroke

Outcome Measures

Primary Outcomes (5)

• 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 for 20 seconds in an upright position without any support or assistance, with her/his feet shoulder-width apart and arms free at the side of the body.

  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 is asked to stand in an upright position with his feet open at shoulder level, arms free at the side of the body, with eyes open and then closed, without losing his balance for 10 seconds before receiving any support. In case of excessive release or failure to continue the test, it is considered a Romberg positive or abnormal Romberg sign. It evaluates the effect of the patient's balance in the closed position.

  Baseline and end of weeks 8.

• One-Legged Standing Test (The change between the initial value and the value after 2 months will be evaluated).

  It is a functional evaluation test that measures the patient's one-leg standing balance. The patient is asked to raise one leg in the air and keep the knee bent at hip level for at least 10 seconds. Times less than 10 seconds indicate a balance disorder, and times less than 5 seconds indicate a risk of falling. It is applied with the patient's eyes open and closed.

  Baseline and end of weeks 8.

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

  It is a test that evaluates functional lower extremity strength, transfer, balance and fall risk. The time for the patient to sit and stand up from the chair 5 times is recorded. It has been proven to be valid in patients with stroke, Parkinson's and Multiple Sclerosis.

  Baseline and end of weeks 8.

• KATZ Independence Index 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 ability of the patient to do daily living activities independently and evaluates the functional status. It examines patient performances in six functions such as bathing, dressing, toilet, transfer, personal care and feeding. Patients score their activity independence in each of the six functions as 1 (independent) or 0 (dependent). A total score of 0 to 2 indicates severe dysfunction, a total score of 2 to 4 indicates moderate dysfunction, and a total score of 4 to 6 indicates full function.

  Baseline and end of weeks 8.

Secondary Outcomes (5)

• Modified Fall Efficiency Scale (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• World Health Organization Quality of Life Scale Short Form Turkish Version (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.

• System Usability Scale (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Global Change Scale (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

Study Arms (6)

Stroke (Telerehabilitation)

EXPERIMENTAL

Exercise therapy with telerehabilitation system

Other: Telerehabilitaton

Stroke (Home Exercise)

OTHER

Exercise therapy with brochure

Other: Home Exercise

Multiple Sclerosis (Telerehabilitation)

EXPERIMENTAL

Exercise therapy with telerehabilitation system

Other: Telerehabilitaton

Multiple Sclerosis (Home Exercise)

OTHER

Exercise therapy with brochure

Other: Home Exercise

Parkinson Disease (Telerehabilitation)

EXPERIMENTAL

Exercise therapy with telerehabilitation system

Other: Telerehabilitaton

Parkinson Disease (Home Exercise)

OTHER

Exercise therapy with brochure

Other: Home Exercise

Interventions

Telerehabilitaton OTHER

Patients will be asked to apply the rehabilitation program defined for them 3 days a week for 8 weeks. A training session will last approximately 45-60 minutes.

Multiple Sclerosis (Telerehabilitation); Parkinson Disease (Telerehabilitation); Stroke (Telerehabilitation)

Home Exercise OTHER

Patients will be asked to apply the rehabilitation program for themselves with an exercise brochure. This therapy will last 3 days a week for 8 weeks.

Multiple Sclerosis (Home Exercise); Parkinson Disease (Home Exercise); Stroke (Home Exercise)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic patients diagnosed with neurological disease at least 1 year ago by a neurologist
• Multiple sclerosis patients with an Expanded Disability Status Scale (EDSS) score of ≤6, who are in the stable phase of the disease and have not had an attack in the last 3 months
• Parkinson's patients with a Hoehn and Yahr score ≤3
• Stroke patients with a modified Rankin score of ≤3
• To have an internet infrastructure where the system can be accessed at home
• Not participating in a standardized physiotherapy and rehabilitation program within the last 3 months
• Having a companion with the patient during the exercises

You may not qualify if:

• Presence of blurred or poor vision problems
• Hearing and speech impairment at a level that will affect participation in the system
• Epilepsy
• The presence of pregnancy
• Having any cognitive problems that prevent using the system
• History of trauma / fracture in the last 3-6 months
• Having pacemaker
• Presence of cardiac problems
• Presence of serious respiratory diseases

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ela Tarakcı, Prof.

  Istanbul University-Cerrahpaşa Faculty of Health Sciences

  STUDY CHAIR

• Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof

  Istanbul University-Cerrahpaşa Faculty of Health Sciences

  STUDY CHAIR

• Murat Kürtüncü, MD

  Istanbul University-Capa Faculty of Medicine, Department of Neurology

  STUDY CHAIR

• Muhammed Erdem İsenkul, Asst. Prof.

  Istanbul University-Cerrahpaşa Faculty of Engineering

  STUDY CHAIR

• Pelin Vural

  Istanbul University-Cerrahpasa Institute of Postgraduate Education

  STUDY CHAIR

• Recep Örmen

  Istanbul University-Cerrahpasa Institute of Postgraduate Education

  STUDY CHAIR

Central Study Contacts

Yonca Zenginler Yazgan, Asst. Prof.

CONTACT

+905344245350; yoncazenginler@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: September 1, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)