Clinical Decision-Making and Virtual Reality Exercise

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Intervertebral Discs; Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Other: VR skateboarding training

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR skateboarding training; specific rehabilitation exercise for improving postural balance	Other: VR 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural balance	The 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)	1 year
Functional assessment	Functional 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).	1 year
Muscle activities	Electromyography is a technique for evaluating and recording muscle activity. The data from electromyography is used to calculate a normalized value (unit: ratio).	1 year
Kinematic variables	A 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).	1 year
Lumbar Cobb angle	The 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)	1 year
Body composition	Body 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 %) .	1 year
Pain by Visual Analog Scale (VAS)	The 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) .	1 year
Roland-Morris Disability Questionnaire (RMDQ)	The 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.	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Li Hsu, Ph.D, National Taiwan Unversity

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality; balance; degenerative lumbar spine disease; biomechanic
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration
• Other Study ID Numbers: 202003149RINC

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