Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: virtual reality walking training

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Li Hsu, Ph.D; Phone Number: +886-2-3366-8127; Email: wlhsu@ntu.edu.tw
• Study Contact Backup: Name: Dar-Ming Lai, Ph.D; Email: dmlai@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wei-Li Hsu, Ph.D; Email: wlhsu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Li Hsu, Ph.D, National Taiwan Unversity

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Lumbar spinal stenosis; Balance ability; Functional assessment; Center of pressure
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 201912150RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No