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Clinical Trials/NCT05425667
NCT05425667
Recruiting
Not Applicable

Sensory System Weighting and Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

National Taiwan University Hospital1 site in 1 country120 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
National Taiwan University Hospital
Enrollment
120
Locations
1
Primary Endpoint
Postural balance: Mean velocity
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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: 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: 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).

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)

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).

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).

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).

Study Sites (1)

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