Influence of Supervised Stabilization Exercises on Postural Control in Patients After Spine Surgery.

NCT05190003 | Unknown

• 1 other identifier: DZN/1/2021/PP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine the impact of early rehabilitation in patients after lumbar spine surgery using microdiscectomy on balance, postural stability and foot pressure distribution. The tests will be carried out at the Physical Effort Laboratory in Gdańsk.

Conditions

Low Back Pain

Keywords

Low back pain,; Microdiscectomy,; Lumbar disc herniation,; Functional exercise,; Lumbar Stabilization Exercise

Outcome Measures

Primary Outcomes (3)

• Modified Schober's Test

  The test is used to assess the flexibility, active range of motion of the lumbar spine. During the examination, the patient assumes a standing position, and the examiner marks a point at the level of the intervertebral space L₅ - S₁. Then he marks the points: 10 cm above and 5 cm below. The examined person is asked to bend the torso as far as possible, the examiner measures the difference in distance from the marked points.

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

• Chair Stand Test (CST)

  The test is used to assess the ability to stand up and down on a chair and lower body strength. The patient is asked to stand up to an upright position and sit with his arms crossed over his chest from a chair of standard height (43 cm) as many times as he can within 30 seconds. Blood pressure and heart rate measurements are collected before and after the test.

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

• "Timed Get-up-and-Go" Test

  This test determines fall risk and measures the progress of balance, sit to stand, and walking. During the test, the patient must get up from the chair and walk 3 meters as quickly as possible and sit down again. A patient has two trials. The better sample is analyzed.

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

Secondary Outcomes (8)

• Body Mass Index (BMI)

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

• Fingertip-to-Floor Test

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

• Romberg's Trial

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

• Tandem Romberg Test

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

• Biodex Balance System SD

  T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.

Study Arms (2)

Study group I: The first time of patients attending single-level lumbar microdiscectomy

EXPERIMENTAL

Study group I: On the basis of neurosurgical examination and MRI imaging, 40 patients aged 20-65 years with pains in the lumbar spine will be referred for the first-time single-level microdiscectomy procedure. Microdiscectomy patients will begin a rehabilitation program that will be includes exercises to reduce pain and strengthen the stabilizing muscles of the lumbar spine. From week to week, exercises will be difficult, among others due to the change of initial positions, the number of repetitions of exercises, or a longer duration of isometric exercises.

Other: Experimental Study

Study group II: Control healthy people

NO INTERVENTION

Study group II: 40 people aged 20-65 years. Including criteria: healthy persons without lumbar spine pain for at least 6 months and without lumbar spine surgery.

Interventions

Experimental Study OTHER

On the basis of neurosurgical examination and MRI imaging, 40 patients aged 20-65 years with pains in the lumbar spine will be referred for the first-time single-level microdiscectomy procedure. Microdiscectomy patients will begin a rehabilitation program that will be includes exercises to reduce pain and strengthen the stabilizing muscles of the lumbar spine. From week to week, exercises will be difficult, among others due to the change of initial positions, the number of repetitions of exercises, or a longer duration of isometric exercises.

Study group I: The first time of patients attending single-level lumbar microdiscectomy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 20 to 65 years, neurosurgical assessment and MRI imagine,discopathy, pernament low back pain with or without radiating to the lower limb.

You may not qualify if:

• patients beyond the age range, a previous lumbar spinal operation, spinal tumors, new fractures, intolerance of rehabilitation programs.

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, 80-336, Poland

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement

Interventions

Non-Randomized Controlled Trials as Topic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Controlled Clinical Trials as Topic; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 13, 2022
• Study Start: April 1, 2021
• Primary Completion: May 10, 2021
• Study Completion: October 31, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

PL (1)