Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425667
• Other study ID #: 201912150RINA
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: Wei-Li Hsu, Ph.D
• Phone: +886-2-3366-8127
• Email: wlhsu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• virtual reality walking training
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year
Primary	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).	1 year
Primary	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).	1 year
Primary	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).	1 year
Primary	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).	1 year
Primary	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)	1 year
Primary	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).	1 year
Primary	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).	1 year
Primary	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).	1 year
Primary	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).	1 year