The Effects of Telerehabilitation-Based Spinal Stabilization Exercises in Stroke Patients

NCT05306522 | Recruiting

• 1 other identifier: KA-21098
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a disease that causes sudden focal neurologic function loss lasting longer than 24 hours due to infarction or hemorrhage in relevant part of the central nervous system. Stroke causes a variety of physiological and psychological symptoms. These symptoms can negatively affect physical activity level and fatigue. Spinal stabilization exercises based on the basic principles of motor learning improves the coordination and endurance of the body muscles by increasing kinesthetic awareness, so this exercise approach can be used to strengthen body stability. The aim of this study is to investigate the effects of telerehabilitation based spinal stabilization exercises on physical activity level and fatigue in community dwelling stroke patients.

Conditions

Stroke

Keywords

stroke; spinal stabilization exercise; telerehabilitation; fatigue; physical activity

Outcome Measures

Primary Outcomes (7)

• Assessment of Physical Activity Level (the mean of the number of steps)

  It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the number of steps taken by the users The following information will be saved: The number of steps in one day: .........steps (the mean of steps in seven days)

  6 weeks

• Assessment of Physical Activity Level (the distance of the patient walks)

  It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the distance the patient walk. The following information will be saved: The distance the patients walks in one day:........meters (the mean of the distance in seven days)

  6 weeks

• Assessment of Physical Activity Level (the time the patient sleeps)

  It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the time the patient sleeps. The following information will be saved: The time the patient sleeps in one day:......minutes (the mean of sleep time in seven days)

  6 weeks

• Assessment of Physical Activity Level (the calories the patient burns)

  It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the calories the patients burn. The following information will be saved: he burned calories in one day:..........calories (the mean of the burned calories in seven days)

  6 weeks

• Fatigue Assessment (physical fatigue)

  Fatigue will be assessed with Fatigue Severity Scale (FSS). FSS is a scale with scores ranging from 7 to 63. It includes 9 items. Increase of the score shows severe fatigue.

  6 weeks

• Fatigue Assessment (cognitive, physical and psychosocial fatigue)

  Fatigue will be assessed with Fatigue İmpact Scale (FIS). FIS is a scale with scores ranging from 0 to 160. . It includes 40 items. It has 3 subscales; cognitive fatigue (10 items), physical fatigue (10 items) and psychosocial fatigue (20 items).

  6 weeks

• Fatigue Assessment (ambulatory fatigue)

  Fatigue will be assessed with linear trend of fatigue. Linear trend of fatigue is calculated from the 6 Minute Walk Test. The formula: (\[(-5\*D1)+(-3\*D2)+(-1\*D5)+(1\*D4)+(3\*D5)+(5\*D6)\])/70 (D1=1 Distance walked in 1st minute, D2=Distance walked in 2nd minute, D3=Distance walked in 3rd minute, D4= Distance walked in 4th minute, D5= Distance walked in 5th minute, D6= distance walked in 6th minute)

  6 weeks

Secondary Outcomes (4)

• Functional Capacity Assessment

  6 weeks

• Trunk İmpairment Assessment

  6 weeks

• Assessment of the Endurance of Core Muscles

  6 weeks

• Quality of Life Assessment

  6 weeks

Study Arms (2)

Telerehabitation Group

EXPERIMENTAL

Patients will undergo telerehabilitation based spinal stabilization exercise 3 days per week for 6 weeks.

Other: Spinal stabilization exercise

Face to face Group

EXPERIMENTAL

Patients will undergo spinal stabilization exercise 3 days per week for 6 weeks.

Other: Spinal stabilization exercise

Interventions

Spinal stabilization exercise OTHER

The effects of telerehabilitation based spinal stabilization exercise in chronic stroke patients will be investigated.

Face to face Group; Telerehabitation Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 50-75 years
• Having an ischemic stroke with anterior circulation involvement
• Getting a score of 24 or higher on the Mini Mental Test
• Ambulation in indoor and outdoor environments with or without a walking aid (walker, cane or tripod)
• At least 1 year has passed since the stroke event
• To have the necessary infrastructure (internet) and equipment (smartphone, tablet or computer) for the telerehabilitation application
• Not participating in any physiotherapy program in the last 6 months
• Volunteering to participate in the study

You may not qualify if:

• Having a history of more than one stroke
• Having a known orthopedic, psychiatric or other neurological disease
• Having a history of surgery involving the lower extremities, abdominal region or gait
• Known presence of dementia
• Presence of aphasia and apraxia

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Stroke; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Ali Naim Ceren

CONTACT

+90 554 5662055; alinaimceren@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: April 1, 2022
• Study Start: April 4, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)