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Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

Primary Purpose

Lumbar Spinal Stenosis

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

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Lumbar spinal stenosis, Functional assessment, Center of pressure, Balance ability

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age between 50 and 79 years old
  2. Patients with lumbar stenosis and neurological claudication diagnosed according to MRI
  3. Timed sit-stand-walk test greater than 9 seconds
  4. Can stand independently for more than 30 seconds

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

Experimental

Arm Description

sensory integration training exercise for improving balance and walking ability of patients with lumbar stenosis and neurological claudication.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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 the duration it took to complete the test (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: 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 joint kinematics. The data is used to calculate the displacement of the center of mass (unit: cm).

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT05425667
Brief Title
Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
Official Title
Sensory System Weighting and Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Lumbar spinal stenosis, Functional assessment, Center of pressure, Balance ability

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
Experimental
Arm Type
Experimental
Arm Description
sensory integration training exercise for improving balance and walking ability of patients with lumbar stenosis and neurological claudication.
Intervention Type
Other
Intervention Name(s)
virtual reality walking training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural balance: Mean velocity
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).
Time Frame
1 year
Title
Postural balance: Mean distance
Description
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).
Time Frame
1 year
Title
Postural balance:Mean frequency
Description
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).
Time Frame
1 year
Title
Postural balance: Ellipse area
Description
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).
Time Frame
1 year
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
1 year
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
1 year
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 the duration it took to complete the test (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: 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
1 year
Title
Kinematic variables: Center of mass
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
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
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

Plan to Share IPD
No

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Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

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