Clinical trial NCT06557681: The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients
Official title: The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time Up and Go (TUG)
timeFrame: Pret-intervention Assessment
measure: Time Up and Go (TUG)
timeFrame: Baseline (Pre-intervention) and immediately after intervention completion (6 weeks after intervention start)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Study officials:
References: