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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05375201
Other study ID # 202003149RINC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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