Clinical trial NCT06750055: Gait Assessment in Lumbar Spinal Stenosis
Official title: Comparison of Walking With Wearable Gait Analysis System in Patients Undergoing Lumbar Spinal Stenosis Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with spinal stenosis who have undergone surgery

Brief summary: Lumbar spinal stenosis (LSS) is a clinical condition in which the structures within the canal are compressed as a result of the narrowing of the lumbar spinal canal and nerve root canals, which is often caused by bones and soft tissues, causing back pain and neurological deficits in the lower extremities. The incidence in the general population has been reported as 1.7-8%. It begins to be seen after the age of 50 and its incidence increases after the age of 65. According to studies, LSS has been detected in 5% of patients who apply to a general practitioner with persistent back pain. Although it can be congenital, most cases of lumbar spinal stenosis are caused by changes in the aging spine as a result of degenerative processes. Changes that can lead to lumbar spinal stenosis include facet joint hypertrophy, decreased intervertebral disc height, osteophyte formation and ligamentum flavum hypertrophy. Clinical findings of LSS include symptoms such as back pain, leg pain, paresthesia, weakness and neurogenic claudication. Patients with neurogenic claudication experience increased pain when walking and standing and decreased pain when bending forward. Patients with LSS often change their spinal posture to allow more lumbar flexion to minimize pain and symptoms while walking; this can lead to gait abnormalities.

Walking function is important for the maintenance of daily living activities. Gait disturbance is associated with poor health outcomes. In a gait cycle, the foot has two distinct phases: stance and swing. These gait phases can be analyzed as a proportion of the gait cycle and compared to normative values. Furthermore, with the use of more advanced systems and devices, it is also possible to assess asymmetries and gait variability in the pelvis and other structures during gait.

Technological advances have led to the emergence of reliable surface sensor technologies capable of gait analysis in the form of wearable accelerometers. These devices provide continuous and objective data streams, including parameters such as daily step count, step rate, and step length. Numerous studies have investigated walking function in LSS patients using various devices including motion capture systems, inertial sensors, accelerometers, wearable technologies, electromyography (EMG) and force platforms. In the study, walking impairment in LSS patients compared to healthy participants was a significant decrease in walking speed and step length, a slight decrease in cadence and a slight increase in step duration. As the double-step support and stance phase ratios increase, the swing phase ratio decreases. Walking asymmetry between the feet also increases in all phases including stance, swing and double-step support. In addition, LSS patients may exhibit gait variability with each step. The reasons for these changing gait patterns are thought to be radicular pain, muscle weakness, low walking tolerance and increased instability with lumbar spine posture in the lumbar extension position during walking.

Winter et al. evaluated the walking ability in daily life in patients with knee or hip osteoarthritis and lumbar spinal stenosis with the help of a wearable accelerometer device. As a result of the study, walking ability was found to be significantly lower in LSS individuals compared to healthy individuals.

Santos et al. examined the kinematic and spatiotemporal gait parameters in patients who underwent surgery with a diagnosis of disc herniation or lumbar stenosis before surgery and 1 and 6 months after surgery. As a result of the study, there was an increase in the pelvis, hip and knee range of motion (ROM) after surgery in the disc herniation group, while there was a decrease in the hip ROM values in the stenosis group. It was also observed that the pelvis and hip ROM of both groups remained smaller in the stance phase compared to the control group.

Papadakis et al. examined the changes in gait in patients with lumbar spinal stenosis with the help of an accelerometer before surgery and 6 and 12 months after surgery and showed that there was a significant decrease in the changes in gait in the postoperative period. It was observed that the improvement in the changes in gait was greater in the first month after surgery compared to the 6th and 12th months after surgery.

Purpose of the study:

The study was planned to compare the gait in healthy and patient groups in patients who underwent LSS surgery.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-65 and discharged from hospital,
* At least 6 weeks and at most 3 months after surgery,
* No other orthopedic and neurological problems,
* Able to communicate,
* Individuals who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Cognitive impairment,
* Other neurologic, psychiatric and/or orthopedic problems other than lumbar spinal stenosis,
* Medically unstable,
* Individuals with open wounds, circulatory problems, skin lesions in the area to be treated will be excluded from the study.

Primary outcomes:
measure: Assessment of Disability Status (Oswestry Disability Index)
timeFrame: 10 minutes
measure: Pain Assessment (Visual Analog Scale-VAS)
timeFrame: 2 minutes
measure: Quality of Life Assessment (SF-12)
timeFrame: 5 minutes
measure: 10 Meter Walk Test
timeFrame: 5 minutes
measure: BTS G-Walk gait analysis system
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: