Clinical Decision-Making and Virtual Reality Exercise

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375201
• Other study ID #: 202003149RINC
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: National Taiwan University Hospital
• Contact: Wei-Li Hsu, Ph.D
• Phone: 886-2-3366-8127
• Email: wlhsu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Intervertebral Discs
• Degenerative Lumbar Spinal Stenosis
• Degenerative Spondylolisthesis
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spondylolisthesis

Intervention

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).

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei, Taiwan, 100

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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