Clinical Decision-Making and Virtual Reality Exercise

NCT05375201 | Completed

• 1 other identifier: 202003149RINC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

VR skateboarding training

EXPERIMENTAL

specific rehabilitation exercise for improving postural balance

Other: VR skateboarding training

Interventions

VR skateboarding training OTHER

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).

VR skateboarding training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) previous lumbar surgery
• \) neurological disorder such as stroke or spinal cord injury
• \) metabolic disease such as diabetes mellitus
• \) vestibular disease such as Meniere's disease.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Related Publications (1)

• Chen JH, Chen PJ, Kantha P, Tsai YC, Lai DM, Hsu WL. Examining the influence of body fat distribution on standing balance and functional performance in overweight female patients with degenerative lumbar disease. Front Bioeng Biotechnol. 2024 Jun 21;12:1375627. doi: 10.3389/fbioe.2024.1375627. eCollection 2024.

  PMID: 38974656 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Wei-Li Hsu, Ph.D

  National Taiwan Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: May 16, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)