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Clinical Decision-Making and Virtual Reality Exercise

Primary Purpose

Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degenerative Spondylolisthesis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
VR skateboarding training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis focused on measuring virtual reality, degenerative lumbar spine disease, rehabilitation, biomechanic, balance

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VR skateboarding training

Arm Description

specific rehabilitation exercise for improving postural balance

Outcomes

Primary Outcome Measures

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)
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 1, 2022
Last Updated
May 31, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05375201
Brief Title
Clinical Decision-Making and Virtual Reality Exercise
Official Title
Optimizing Clinical Decision-Making and Virtual Reality Exercise Training in Degenerative Lumbar Spine Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Intervertebral Discs
Keywords
virtual reality, degenerative lumbar spine disease, rehabilitation, biomechanic, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR skateboarding training
Arm Type
Experimental
Arm Description
specific rehabilitation exercise for improving postural balance
Intervention Type
Other
Intervention Name(s)
VR skateboarding training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postural balance
Description
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)
Time Frame
1 year
Title
Functional assessment
Description
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).
Time Frame
1 year
Title
Muscle activities
Description
Electromyography is a technique for evaluating and recording muscle activity. The data from electromyography is used to calculate a normalized value (unit: ratio).
Time Frame
1 year
Title
Kinematic variables
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Li Hsu, Ph.D
Phone
886-2-3366-8127
Email
wlhsu@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Dar-Ming Lai, Ph.D
Email
dmlai@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Hsu, Ph.D
Organizational Affiliation
National Taiwan Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei, Taiwan, 100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Li Hsu, Ph.D
Email
wlhsu@ntu.edu.tw

12. IPD Sharing Statement

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Clinical Decision-Making and Virtual Reality Exercise

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