Comparıson of vırtual realıty-Based walkıng and treadmıll exercıse Effects on Balance and Balance ın Chronic Stroke

NCT07715526 | Completed

• 1 other identifier: 25-127
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of virtual reality-based walking exercises and treadmill walking exercises on balance, fear of falling, motor function, respiratory function, and fatigue in individuals who have had a stroke. The main questions it aims to answer are: How do virtual reality-based gait exercises and treadmill exercises affect balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke? H0: There is no statistically significant difference between virtual reality-based gait exercises and treadmill exercises in terms of their effects on balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke. H1: There is a statistically significant difference between virtual reality-based gait exercises and treadmill exercises in terms of their effects on balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke.

Conditions

Chronic Stroke Patients

Keywords

chronic stroke; virtual reality; balance; fear of falling; motor function; respiratory function; fatigue; physiotherapy and rehabilitation; neurological rehabilitation

Outcome Measures

Primary Outcomes (5)

• Respiratory Outcome Measures - Volume (L)

  Respiratory parameters will be assessed at baseline and Week 6 using a COSMED PONY spirometer, with the best of three acceptable attempts recorded for each measure. The primary spirometric outcomes in this category include FEV1 (L), FVC (L), and VC (L).

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

• Respiratory Outcome Measures - Ratio (%)

  The FEV1/FVC ratio (%) will be recorded as a separate spirometric outcome.

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

• Respiratory Outcome Measures - Flow Rate (L/min)

  Peak expiratory flow (PEF) and maximum voluntary ventilation (MVV) will be measured in L/min.

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

• Respiratory Outcome Measures - Flow Rate (L/s)

  Forced expiratory flow at 25-75% of the pulmonary volume (FEF 25-75%) will be measured in L/s.

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

• Respiratory Outcome Measures - Pressure (cmH₂O)

  Maximum inspiratory and expiratory pressures (MIP and MEP) will be measured using a pressure manometer with a nasal clip, with the highest of three attempts recorded in cmH₂O.

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

Secondary Outcomes (6)

• EVALUATION OF MOTOR FUNCTIONS

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

• ASSESSMENT OF FEAR OF FALLING

  FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

• ASSESSMENT OF FUNCTIONAL INDEPENDENCE

  UNTIL THE END OF 6 WEEKS OF TREATMENT

• EVALUATION OF FUNCTIONAL AMBULATION

  UNTIL THE END OF 6 WEEKS OF TREATMENT

• ASSESSMENT OF FUNCTIONAL CAPACITY

  UNTIL THE END OF 6 WEEKS OF TREATMENT

Study Arms (2)

Virtual Reality-Based Walking Exercise Group

ACTIVE COMPARATOR

Conventional physiotherapy + VR (virtual reality) Therapy / 45 min, 5 sessions per week / 6 weeks The patient will be shown a 3D video including a 15-minute nature walk while wearing virtual reality glasses.

Other: Virtual Reality-Based Walking Exercise

Treadmill Walking Exercise Group

ACTIVE COMPARATOR

Conventional physiotherapy + Treadmill / 45 min per week 5 sessions/6 weeks Walking speed will be calculated based on the 10-meter walking test performed at the beginning of the study; patients will then perform 15-minute walking exercises on the treadmill.

Other: Treadmill Walking Exercise Group

Interventions

Treadmill Walking Exercise Group OTHER

Conventional physical therapy + Treadmill / 45 min per week 5 sessions/6 weeks Walking speed will be calculated based on a 10-meter walking test performed at the start of the study; patients will perform a 15-minute walking exercise on the treadmill.

Treadmill Walking Exercise Group

Virtual Reality-Based Walking Exercise OTHER

Conventional physiotherapy + VR Therapy / 45 min, 5 sessions per week / 6 weeks The patient will be shown a 3D video including a 15-minute nature walk while wearing virtual reality glasses.

Virtual Reality-Based Walking Exercise Group

Eligibility Criteria

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

You may qualify if:

• Chronic stroke patients with hemiparesis (stroke \>6 months post-stroke).
• Ages 18-75.
• No visual, auditory, or communication problems.
• No additional neurological, cardiovascular, orthopedic, etc. conditions causing balance problems. Mini-Mental State Assessment (MMSE) score ≥24
• Functional Ambulation Classification (FAS) level 4-5
• Impaired pulmonary function (FEV1/FVC \<70% with spirometry)
• Providing informed consent and being a volunteer
• Speaking and understanding Turkish.

You may not qualify if:

• Peripheral occlusive arterial disease
• Uncontrolled hypertension (≥190/110 mmHg)
• History of epilepsy
• Inability to respond to visual and sensory stimuli
• Orthopedic problems restricting movement in the lower extremities
• Having undergone any botulinum toxin application or surgery within the last 6 months
• Having neglect syndrome or speech disorders
• Vestibular system problems or use of medications that may affect the vestibular system

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University

Istanbul, Zeytinburnu, 34275, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration; Fatigue

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Gokay KUCUKYILMAZ, BSc

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Two groups and additional conventional physiotherapy applications.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: July 20, 2026
• Study Start: March 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: June 29, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)