Lumbar Spinal StenosisNCT05425667
Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
A study testing virtual reality walking training in people with Lumbar Spinal Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lumbar spinal stenosis is a common degenerative disease in the elderly. Patients are often accompanied by paresthesias and decreased musculoskeletal system functions, resulting in disability and increasing the burden of medical care. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- virtual reality walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 50 and 79 years old
- Patients with lumbar stenosis and neurological claudication diagnosed according to MRI
- Timed sit-stand-walk test greater than 9 seconds
- Can stand independently for more than 30 seconds
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Dar-Ming Lai, Ph.D contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Wei-Li Hsu, Ph.D, wlhsu@ntu.edu.tw
About this study
Official title: Sensory System Weighting and Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
Lumbar spinal stenosis is a common degenerative disease in the elderly. Patients are often accompanied by paresthesias and decreased musculoskeletal system functions, resulting in disability and increasing the burden of medical care. The balance and walking ability of such patients are affected by the compressed nerves, so it is necessary to reorganize the nerve sensory systems to compensate for the disability caused by lumbar stenosis. It is necessary to strengthen the training of sensory integration ability, but it has not been Studies have investigated which treatments or surgery can improve sensory integration in patients with lumbar stenosis. Therefore, this study will develop a clinical tool to objectively evaluate sensory integration, quantify the sensory integration ability of patients with lumbar stenosis and neurological claudication; The influence and mechanism of the balance ability.
Read the detailed description
Objective 1. To develop a sensory integration assessment tool for patients with lumbar stenosis, in order to explore the distribution ratio of sensory system weights between them and healthy elders of the same age without lumbar stenosis under different balance disturbance stimuli.
Objective 2. To explore the distribution ratio of sensory system weights and long-term tracking of changes in sensory system weights in patients with lumbar stenosis and neurological claudication who received sensory integration training after spinal decompression surgery.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- virtual reality walking training
- Keywords
- Lumbar spinal stenosis, Functional assessment, Center of pressure, Balance ability
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality walking trainingOther
The sensory integration training of this project will combine virtual reality technology and balance interference treadmill, and manipulate vision, vestibular sense and proprioceptive systems as the main training goals. It is expected to train twice a week for 1 hour, for a total of 6 weeks of training , in order to improve the balance and walking ability of patients with lumbar stenosis and neurological claudication, and to promote the ability of subjects to transfer the effect to daily life after training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | sensory integration training exercise for improving balance and walking ability of patients with lumbar stenosis and neurological claudication. Receives: Other: virtual reality walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural balance: Mean velocity
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).
Measured: 1 year
Postural balance: Mean distance
The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate the mean distance (unit: cm).
Measured: 1 year
Postural balance:Ｍean frequency
The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate the mean frequency (unit: Hz).
Measured: 1 year
Postural balance: Ellipse area
The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate 95% confidence ellipse area (unit: cm^2).
Measured: 1 year
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).
Measured: 1 year
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)
Measured: 1 year
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 the duration it took to complete the test (unit: s).
Measured: 1 year
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).
Measured: 1 year
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).
Measured: 1 year
Kinematic variables: Center of mass
A motion capture system is used to measure the joint kinematics. The data is used to calculate the displacement of the center of mass (unit: cm).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Apr 2021
- Primary completion15 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, Ph.D, Principal investigator, National Taiwan Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425667
- Sponsor's protocol ID
- 201912150RINA
- Status last verified
- Mar 2023
- First submitted
- 13 Jun 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory System Weighting and Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT05425667
- Acronym / sponsor ID
- 201912150RINA
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis, Functional assessment, Center of pressure, Balance ability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar spinal stenosis is a common degenerative disease in the elderly. Patients are often accompanied by paresthesias and decreased musculoskeletal system functions, resulting in disability and increasing the burden of medical care. The balance and walking ability of such patients are affected by the compressed nerves, so it is necessary to reorganize the nerve sensory systems to compensate for the disability caused by lumbar stenosis. It is necessary to strengthen the training of sensory integration ability, but it has not been Studies have investigated which treatments or surgery can improve sensory integration in patients with lumbar stenosis. Therefore, this study will develop a clinical tool to objectively evaluate sensory integration, quantify the sensory integration ability of patients with lumbar stenosis and neurological claudication; The influence and mechanism of the balance ability.
Detailed description
Objective 1. To develop a sensory integration assessment tool for patients with lumbar stenosis, in order to explore the distribution ratio of sensory system weights between them and healthy elders of the same age without lumbar stenosis under different balance disturbance stimuli.
Objective 2. To explore the distribution ratio of sensory system weights and long-term tracking of changes in sensory system weights in patients with lumbar stenosis and neurological claudication who received sensory integration training after spinal decompression surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: virtual reality walking trainingsensory integration training exercise for improving balance and walking ability of patients with lumbar stenosis and neurological claudication. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 50 and 79 years old
- Patients with lumbar stenosis and neurological claudication diagnosed according to MRI
- Timed sit-stand-walk test greater than 9 seconds
- Can stand independently for more than 30 seconds
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality walking trainingThe sensory integration training of this project will combine virtual reality technology and balance interference treadmill, and manipulate vision, vestibular sense and proprioceptive systems as the main training goals. It is expected to train twice a week for 1 hour, for a total of 6 weeks of training , in order to improve the balance and walking ability of patients with lumbar stenosis and neurological claudication, and to promote the ability of subjects to transfer the effect to daily life after training. | Other | Experimental |
Primary outcome
Postural balance: Mean velocity
Time frame: 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).
Postural balance: Mean distance
Time frame: 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 distance (unit: cm).
Postural balance:Ｍean frequency
Time frame: 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 frequency (unit: Hz).
Postural balance: Ellipse area
Time frame: 1 year
The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate 95% confidence ellipse area (unit: cm^2).
Functional assessment: Walking speed
Time frame: 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).
Functional assessment: Walking distance
Time frame: 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 distance (unit: m)
Functional assessment: Duration
Time frame: 1 year
Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate the duration it took to complete the test (unit: s).
Muscle activities
Time frame: 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: Joint angles
Time frame: 1 year
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
Time frame: 1 year
A motion capture system is used to measure the joint kinematics. The data is used to calculate the displacement of the center of mass (unit: cm).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dar-Ming Lai, Ph.D contact
Wei-Li Hsu, Ph.D principal investigator
National Taiwan Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality walking training in people with Lumbar Spinal Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Li Hsu, Ph.D (+886-2-3366-8127, wlhsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural balance: Mean velocity (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.