Clinical Decision-Making and Virtual Reality Exercise

Not Applicable

Recruiting

• Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Intervertebral Discs
• Interventions: Other: VR skateboarding training

• Registration Number: NCT05375201
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-16
• Status Verified: 2023-05
• Last Update Submitted: 2024-04-21
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR skateboarding training	VR skateboarding training	specific rehabilitation exercise for improving postural balance

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan, 100, Taiwan