Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

NCT05425667 | Unknown

• 1 other identifier: 201912150RINA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis; Functional assessment; Center of pressure; Balance ability

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

Study Arms (1)

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

Interventions

virtual reality walking training OTHER

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.

Experimental

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Wei-Li Hsu, Ph.D

  National Taiwan Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Li Hsu, Ph.D

CONTACT

+886-2-3366-8127; wlhsu@ntu.edu.tw

Dar-Ming Lai, Ph.D

CONTACT

dmlai@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 21, 2022
• Study Start: April 15, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)