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Clinical Trials/NCT06557681
NCT06557681Active, not recruitingNot Applicable

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

Yonsei University1 site in 1 country30 target enrollmentStarted: March 25, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Locations
1
Primary Endpoint
Time Up and Go (TUG)

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Arms & Interventions

Experimental Group

Experimental

Receives conventional therapy (physical therapy)

Intervention: Virtual Reality-Treadmill Training Group (VTT) (Device)

Control Group

Experimental

Receives conventional therapy (physical therapy)

Intervention: Conventional Therapy Group (CT) (Other)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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