The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients

Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Recent studies have shown that treadmill-based walking training incorporating virtual reality can help improve walking and balance functions in actual stroke patients. However, there are few randomized clinical trials with control groups, highlighting the need for further research to ensure the reliability of clinical effects.

Therefore, this study aims to investigate the impact of treadmill-based training incorporating virtual reality on walking and balance functions. The training equipment to be used is the C-mill VR+ device, which enables walking training and assessment, balance training and assessment, and obstacle training using a front screen and treadmill videos. The investigators intend to thoroughly examine the walking ability and balance ability of the subjects obtained through this equipment, along with various evaluation tools.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Criteria:

Adult patients aged 19 years or older.
Confirmed diagnosis of stroke by a neurologist or neurosurgeon through radiological methods such as CT or MRI.
Chronic hemiplegic stroke patients, six months post-stroke onset.
Patients with a Functional Ambulatory Category score of 3 or higher.
Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who understand the study, are willing to participate voluntarily, and have given consent to participate.
Exclusion Criteria:

Acute/subacute stroke patients within six months of stroke symptom onset.
Patients with quadriplegia.
Patients with ataxia.
Patients with severe joint contracture of the lower limbs that makes wearing orthotics difficult.
Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking.
Any other cases deemed inappropriate for participation by the researcher.

Treatment and study plan

Virtual Reality-Treadmill Training Group (VTT)

Device

The Virtual Reality-Treadmill Training Group (VTT) will consist of 15 participants who will undergo 12 training sessions over 6 weeks, with each session occurring twice a week. Each session will include 30 minutes of conventional rehabilitation therapy followed by an additional 30 minutes of virtual reality-treadmill training. The sequence of these therapies can vary with each session. The virtual reality-treadmill training, conducted under the supervision of a therapist, will focus on five key components: precision stepping, obstacle negotiation, direction of progression, precision acceleration, and walking velocity. Evaluations of walking and balance abilities will be conducted before and after the intervention.

Conventional Therapy Group (CT)

Other

The Conventional Therapy Group (CT) will consist of 15 participants who will undergo 12 training sessions over 6 weeks, with each session occurring twice a week. Each session will include 30 minutes of conventional rehabilitation therapy, aimed at improving walking and balance functions. The therapy will be administered by a therapist and may include exercises focused on muscle strength increase, gait training for step length and walking speed improvement, and balance training. Evaluations of walking and balance abilities will be conducted before and after the intervention.

Primary outcomes

Time Up and Go (TUG)

Time frame: Pret-intervention Assessment

The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.
Time Up and Go (TUG)

Time frame: Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)

The Timed Up and Go (TUG) test is a simple and reliable assessment used to evaluate a patient's mobility and balance abilities. During the test, the patient starts seated in a chair, then stands up, walks 3 meters to a designated marker, turns around, walks back to the chair, and sits down. The time taken to complete this sequence is measured. Shorter completion times indicate better mobility and balance. The TUG test is widely used to assess walking ability and fall risk in various conditions, including stroke and geriatric disorders.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 16, 2024
Registry last updated: Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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