NCT05425680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

4.3 years

First QC Date

June 13, 2022

Last Update Submit

July 23, 2025

Conditions

Keywords

degenerative lumbar spine diseasevirtual realitytelehealthreal-time detection

Outcome Measures

Primary Outcomes (8)

  • 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).

    6 months

  • 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).

    6 months

  • 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).

    6 months

  • 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)

    6 months

  • 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).

    6 months

  • 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).

    6 months

  • Kinetic variables

    A motion capture system is used to measure the joint kinetics. The data is used to calculate joint moments (unit: Nm)

    6 months

  • 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).

    6 months

Study Arms (1)

Core muscle training

EXPERIMENTAL

specific rehabilitation exercise for improving functional movements

Other: Core muscle training

Interventions

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.

Core muscle training

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to stand and walk for 5 minutes independently
  • aged between 50 and 80 years
  • received a diagnosis of DLSD based on imaging

You may not qualify if:

  • neurological disorder such as stroke or spinal cord injury
  • metabolic disease such as diabetes mellitus
  • vestibular disease such as Meniere's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital or Movement Science Lab of National Taiwan University

Taipei, Taipei, 100, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Wei-Li Hsu, Ph.D.

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 21, 2022

Study Start

April 15, 2021

Primary Completion

July 15, 2025

Study Completion

July 15, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations