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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Hemiplegia
• Intervention / Treatment: Device: Virtual Reality-Treadmill Training Group (VTT); Other: Conventional Therapy Group (CT)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  1. Adult patients aged 19 years or older.
  2. Confirmed diagnosis of stroke by a neurologist or neurosurgeon through radiological methods such as CT or MRI.
  3. Chronic hemiplegic stroke patients, six months post-stroke onset.
  4. Patients with a Functional Ambulatory Category score of 3 or higher.
  5. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Receives conventional therapy (physical therapy)	Device: Virtual Reality-Treadmill Training Group (VTT); 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.
Experimental: Control Group; Receives conventional therapy (physical therapy)	Other: Conventional Therapy Group (CT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Up and Go (TUG)	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.	Pret-intervention Assessment
Time Up and Go (TUG)	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.	Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): September 27, 2024
• Study Completion (Estimated): September 27, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: 1-2023-0088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No