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Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases

Primary Purpose

Degenerative Lumbar Spine Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Core muscle 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 Spine Diseases focused on measuring degenerative lumbar spine disease, virtual reality, telehealth, real-time detection

Eligibility Criteria

20 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 Hospital or Movement Science Lab of National Taiwan UniversityRecruiting
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Core muscle training

Arm Description

specific rehabilitation exercise for improving functional movements

Outcomes

Primary Outcome Measures

Functional assessment: Walking speed
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).
Functional assessment: Walking distance
Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking distance (unit: m).
Functional assessment: Duration
Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate calculate the duration it took to complete the test (unit: s).
Postural balance
he postural balance measurements are performed by using a inertial sensor. The data from the inertial sensor is used to calculate the 95% confidence ellipse area (unit: cm^2)
Kinematic variables: Joint angles
A motion capture system is used to measure the joint kinematics. The data is used to calculate joint angles (unit: degree).
Kinematic variables: Center of mass
A motion capture system is used to measure the displacement of the center of mass. The data is used to calculate the displacement of the center of mass (unit: cm).
Kinetic variables
A motion capture system is used to measure the joint kinetics. The data is used to calculate joint moments (unit: Nm)
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).

Secondary Outcome Measures

Full Information

First Posted
June 13, 2022
Last Updated
October 19, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05425680
Brief Title
Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases
Official Title
Clinical Effectiveness and Biomechanics Study for Remote Intelligent Interactive Virtual Reality Assessment and Rehabilitation in Patients With Degenerative Lumbar Spine Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (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

5. Study Description

Brief Summary
This study will combine virtual reality (VR) technology with machine learning to focus on functional movement. Patients' symptoms will be evaluated, and exercise instruction with real-time feedback will be provided. The goals of this research are to: (1) develop a waist digital sensor for real-time monitoring as an evaluation tool, (2) apply a real-time monitoring system in conjunction with virtual reality for telerehabilitation, and (3) develop the standard model.
Detailed Description
The remote assessment and training in this study can assist patients obtaining physical therapy care at home. It is suitable for patients who avoid going to the hospital due to the epidemic, and solve the problem of long-term treatment. The outcomes will provide DLSD patients tele-rehabilitation platform and system, help medical personnel to treat patients more effectively in the future, and reduce the burden of medical costs on close ones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spine Diseases
Keywords
degenerative lumbar spine disease, virtual reality, telehealth, real-time detection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Core muscle training
Arm Type
Experimental
Arm Description
specific rehabilitation exercise for improving functional movements
Intervention Type
Other
Intervention Name(s)
Core muscle training
Intervention Description
Combining virtual reality technology and waist wearable sensors, training the pelvis and lumbar spine movements as the main training goal, it is estimated that two 1-hour training sessions per week, a total of 6 weeks of training, to improve the core muscle of patients with lumbar degenerative diseases muscle strength.
Primary Outcome Measure Information:
Title
Functional assessment: Walking speed
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).
Time Frame
6 months
Title
Functional assessment: Walking distance
Description
Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking distance (unit: m).
Time Frame
6 months
Title
Functional assessment: Duration
Description
Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate calculate the duration it took to complete the test (unit: s).
Time Frame
6 months
Title
Postural balance
Description
he postural balance measurements are performed by using a inertial sensor. The data from the inertial sensor is used to calculate the 95% confidence ellipse area (unit: cm^2)
Time Frame
6 months
Title
Kinematic variables: Joint angles
Description
A motion capture system is used to measure the joint kinematics. The data is used to calculate joint angles (unit: degree).
Time Frame
6 months
Title
Kinematic variables: Center of mass
Description
A motion capture system is used to measure the displacement of the center of mass. The data is used to calculate the displacement of the center of mass (unit: cm).
Time Frame
6 months
Title
Kinetic variables
Description
A motion capture system is used to measure the joint kinetics. The data is used to calculate joint moments (unit: Nm)
Time Frame
6 months
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
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: able to stand and walk for 5 minutes independently aged between 50 and 80 years received a diagnosis of DLSD based on imaging Exclusion Criteria: 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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Hsu, Ph.D.
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital or Movement Science Lab of National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Li Hsu, Ph.D.
Phone
886-2-3366-8127
Email
wlhsu@ntu.edu.tw

12. IPD Sharing Statement

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Remote Intelligent Interactive Virtual Reality Assessment in Patients With Degenerative Lumbar Spine Diseases

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