Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

Not Applicable

Recruiting

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: virtual reality walking training

• Registration Number: NCT05425667
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Status Verified: 2023-03
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	virtual reality walking training	sensory integration training exercise for improving balance and walking ability of patients with lumbar stenosis and neurological claudication.

Primary Outcome Measures

Name	Time	Method
Postural balance: Mean velocity	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	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	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	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	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	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	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	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	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	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).

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan