Clinical trial NCT05425667: Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
Official title: Sensory System Weighting and Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar spinal stenosis
Functional assessment
Center of pressure
Balance ability
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postural balance: Mean velocity
timeFrame: 1 year
measure: Postural balance: Mean distance
timeFrame: 1 year
measure: Postural balance:Ｍean frequency
timeFrame: 1 year
measure: Postural balance: Ellipse area
timeFrame: 1 year
measure: Functional assessment: Walking speed
timeFrame: 1 year
measure: Functional assessment: Walking distance
timeFrame: 1 year
measure: Functional assessment: Duration
timeFrame: 1 year
measure: Muscle activities
timeFrame: 1 year
measure: Kinematic variables: Joint angles
timeFrame: 1 year
measure: Kinematic variables: Center of mass
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan Unversity
name: Wei-Li Hsu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: