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

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Yonsei University

Status

Active, not recruiting

Conditions

Stroke
Hemiplegia

Treatments

Other: Conventional Therapy Group (CT)
Device: Virtual Reality-Treadmill Training Group (VTT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06557681
1-2023-0088

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Experimental Group
Experimental group
Description:
Receives conventional therapy (physical therapy)
Treatment:
Device: Virtual Reality-Treadmill Training Group (VTT)
Control Group
Experimental group
Description:
Receives conventional therapy (physical therapy)
Treatment:
Other: Conventional Therapy Group (CT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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