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Clinical Decision-Making and Virtual Reality Exercise

Optimizing Clinical Decision-Making and Virtual Reality Exercise Training in Degenerative Lumbar Spine Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375201
Enrollment
200
Registered
2022-05-16
Start date
2021-01-01
Completion date
2024-12-31
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease, Degenerative Intervertebral Discs, Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis

Keywords

virtual reality, degenerative lumbar spine disease, rehabilitation, biomechanic, balance

Brief summary

Degenerative lumbar spine disease (DLSD) is common in elderly individuals and can result in pain, muscle weakness, and paresthesia. Numerous studies have reported that patients with DLSD usually have postural balance instability, which may affect the patient's gait, functional activities, and quality of life. The investigators propose to achieve the following aims: (1) to develop a clinical balance diagnostic tool to identify patients with DLSD who may require lumbar surgery (2) to investigate the effects of virtual reality skateboard exercise training on gait and balance in patients with DLSD, as well as to compare them with asymptomatic participants.

Interventions

OTHERVR skateboarding training

The virtual reality skateboard training (VR-skate) is used treadmill-based training. Virtual reality system is integrated into the split-belt treadmill for VR-skate. Participants slide the swing leg (sliding leg) along with the moving treadmill belt at a comfortable speed (same as walking speed).

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 1\) able to stand and walk for 5 minutes independently * 2\) aged between 50 and 80 years * 3\) received a diagnosis of DLSD based on imaging

Exclusion criteria

* 1\) previous lumbar surgery * 2\) neurological disorder such as stroke or spinal cord injury * 3\) metabolic disease such as diabetes mellitus * 4\) vestibular disease such as Meniere's disease.

Design outcomes

Primary

MeasureTime frameDescription
Postural balance1 yearThe postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate the mean velocity (unit: cm/s), mean distance (unit: cm), mean frequency (unit: Hz), and 95% confidence ellipse area (unit: cm\^2)
Functional assessment1 yearFunctional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking speed (unit: m/s), walking distance (unit: m), and duration (unit: s).
Muscle activities1 yearElectromyography is a technique for evaluating and recording muscle activity. The data from electromyography is used to calculate a normalized value (unit: ratio).
Kinematic variables1 yearA motion capture system is used to measure the joint kinematics. The data is used to calculate joint angles (unit: degree) and the displacement of the center of mass (unit: cm).
Lumbar Cobb angle1 yearThe Lumbar Cobb angle is a measure of the curvature in the lower spine, determined from X-ray images by assessing the angle between the most tilted vertebrae (unit: degree)
Body composition1 yearBody composition was evaluated utilizing the bioelectrical impedance analysis technique. The primary parameters assessed encompassed body fat percentage, visceral fat area, lean muscle mass of the trunk, and the average muscle mass of the lower extremities (unit: percentage %) .
Pain by Visual Analog Scale (VAS)1 yearThe VAS pain scale, ranging from 1 to 10, provides a rapid assessment of pain intensity, with individuals marking their level of pain on a line from no pain to worst pain imaginable (unit: score) .
Roland-Morris Disability Questionnaire (RMDQ)1 yearThe RMDQ (Roland-Morris Disability Questionnaire) is a widely used self-reported questionnaire that assesses the impact of low back pain on daily functioning. It consists of 24 statements related to daily activities affected by back pain. It's commonly used in clinical settings to evaluate the severity of low back pain and track treatment progress (unit: score). Scores range from 0 to 24, with higher scores indicating more severe disability.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026