Kyphosis Clinical Trial
Official title:
Investigation of the Effect of Thoracic Kyphosis on Posture, Proprioception and Perception of Postural Appearance in Young Individuals
Verified date | May 2024 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Although the negative effect of increased thoracic kyphosis in elderly individuals has been reported in the literature, the effect of the thoracic kyphosis angle on trunk and foot proprioception in young individuals has not been investigated. The aim of this study was to investigate the effect of the thoracic kyphosis on posture, proprioception and perception of postural appearance in young individuals.
Status | Enrolling by invitation |
Enrollment | 46 |
Est. completion date | September 16, 2024 |
Est. primary completion date | August 16, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - Between 18 and 25 years of age - Not being treated for kyphosis in the last 6 months Exclusion Criteria: - Those diagnosed with scoliosis and/or structural spinal deformity - Those with any neurological deficit - Those with concomitant disorders such as Scheuermann's disease, genetic diseases such as Beckwith-Wiedemann Syndrome or metabolic diseases that may affect body axis disorders - Those with lower limb deformities - Those with a history of spinal fracture and/or surgery and/or shoulder joint injury - Those with mental disorders and intellectual disabilities. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University | Istanbul | Beykoz |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medipol University Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proprioception evaluation; Evaluation of Trunk Joint Position Sensation | The BASELINE brand digital goniometer (Baseline 10044E Digital Absolute + Axis Goniometer 10044E SKU: CM10044E) can be employed for the measurement of joint position sense. Prior to commencing the measurement, participants are instructed to assume four different positions in a comfortable standing position. The participants are required to perform 30° flexion, 15° extension, 15° right and left lateral flexion for an active proprioceptive positioning test with their eyes closed. Following each position, the participants are instructed to wait for three seconds and to feel the position. They then return to the upright position and are asked to return to the position they felt and measured in that position. The deviation degrees of the participants are recorded. This process is repeated three times, with the resulting degrees of deviation averaged. During the measurement, it is essential to ensure that flexion in the knees is avoided. | 10 minute | |
Secondary | The Body Sensation Assessment | The Body Sensation Assessment is a procedure designed to evaluate the physical sensations experienced by the subject. The assessor will then proceed to touch the T4, T5 and T6 spinous processes with a monofilament. The Semmes-Weinstein monofilament kit will be employed for the purpose of sensory evaluation. The monofilament is applied at an angle of 90°C until the tip of the monofilament is curled. The areas to be tested are maintained in contact with the monofilament for a period of 1.5 seconds, after which the monofilament is removed from the skin. Subsequently, the participant is queried as to whether they perceive the sensation and is requested to provide feedback as to whether they do or do not feel it. In the monofilament kit, starting from 2.83 and continuing up to 6.65, the initial filament, 2.83, was tested. If the participant did not perceive it, the next higher level, the thicker filament, was then evaluated. | 10 minute | |
Secondary | The evaluation of foot sensation | The sole of the foot is tested at four sites: the heel, medial arch, lateral arch and first metatarsal. The heel position was determined to be the centre of the heel at 15% of the sole length. The medial arch position is located at 15% of the arch width from the medial border. The lateral arch is defined as the projection of the medial arch. The first metatarsal position is marked at 15% of the metatarsal width from the lateral and medial borders, respectively.
For the dorsum of the foot, a region was delineated with the proximal boundary at 15% of the length from the lateral malleoli to the fibular head and the distal boundary at 75% of the length from the lateral malleoli to the fifth metatarsal. The dorsum test sites included a proximal, middle and distal region, each marked at a distance of 10%, 50% and 90% from the proximal border of the reference region, respectively. The Semmes-Weinstein monofilament kit will be employed for the purpose of sensory evaluation. |
10 min | |
Secondary | Ankle Joint Position Sensation Evaluation | The baseline brand digital goniometer (Baseline 10044E Digital Absolute + Axis Goniometer 10044E SKU: CM10044E) can be utilised for the measurement of joint position sense. The participants are blindfolded in order to prevent visual notifications. For the measurement of plantarflexion and dorsiflexion, the pivot point of the digital goniometer is placed 1.5 cm below the lateral malleolus. The fixed arm is parallel to the longitudinal axis of the fibula and aligned with the fibular head, while the mobile arm is parallel to the longitudinal axis of the fifth metatarsal. Participants are asked to perform 10° dorsiflexion, 10° and 20° plantarflexion. Individuals are instructed to actively perform the desired target angles, sense the position of the ankle for three seconds, and then return to the starting position. Individuals are then asked to repeat the target angle, and the measurement is taken in this position. | 10 min | |
Secondary | Cervical Joint Position Sense Assessment | Cervical position sense can be evaluated by utilising a laser pointer mounted on a lightweight headband. The subject is seated in a relaxed position with their knees and hips at 90° angles, their hands placed on their knees, in front of a sheet of paper containing a coordinate plane of A2 size and 40 cm in diameter at a distance of 90 cm, positioned at eye level. The participants are requested to focus on the natural resting head position and the origin for a period of three seconds. Subsequently, the participants are instructed to perform flexion, extension, and right-left rotation movements with their eyes closed, pausing for three seconds after each position. Subsequently, the participants are instructed to attempt to return to the initial focused position as much as possible. The point at which the participant perceives the laser beam to have reached the focal starting point is marked. The procedure should be repeated three times, and the mean value should be recorded. | 10 min | |
Secondary | Postural Assessment | A postural assessment will be conducted using the PostureScreen Mobile application. PostureScreen Mobile represents a pioneering application for the rapid assessment of posture. It has been demonstrated to be both valid and reliable. A camera, mounted on a tripod at shoulder height, was used to photograph the subject in lateral posture while standing in a comfortable, natural position. The angles corresponding to the photograph were then calculated. The craniovertebral angle (CVA) is the angle between the line joining the tragus of the ear to C7 and the horizontal line at C7. The shoulder angle (SA) is defined as the angle between the line joining C7 to the acromion process and the horizontal line at the acromion process. The sagittal head angle (SHA) is the angle between the line joining the tragus of the ear to the canthus of the eye and the horizontal line at the tragus. | 5 min | |
Secondary | Postural Appearance Perception | The Kyphosis Specific Spine Appearance Questionnaire (KSAQ), adapted into Turkish, will be used to assess the perception of postural appearance. The KSAQ is a reliable and valid patient-reported outcome tool to assess individual perception of various aspects of kyphotic deformity and appearance in young patients with kyphosis. The KSAQ is a 10-item questionnaire based on a five-point Likert scale ranging from 1 to 5, with 1 being not true; 2, somewhat true; 3, true; 4, very true; and 5, completely true. For the Kyphosis Specific Spine Appearance Questionnaire, the mean of the responses is used to obtain a total score. It is related to patients' perception of appearance, with higher scores indicating worsening of the deformity. | 5 min |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT01461005 -
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
|
N/A | |
Completed |
NCT00781729 -
Yoga for Kyphosis Trial
|
Phase 2 | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|
||
Completed |
NCT02950532 -
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
|
||
Withdrawn |
NCT01441999 -
Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection
|
N/A | |
Completed |
NCT04834141 -
Correlation Between Thoracic Kyphosis Posture and Static Balance
|
||
Recruiting |
NCT06082739 -
Managing Kyphosis With Exercise
|
N/A | |
Completed |
NCT03193905 -
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
|
N/A | |
Completed |
NCT06153511 -
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
|
N/A | |
Recruiting |
NCT06093477 -
Studying Melatonin and Recovery in Teens
|
N/A | |
Recruiting |
NCT02768675 -
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
|
N/A | |
Not yet recruiting |
NCT06369883 -
How Often and What Type of Deformity is Detected in All Spine Radiographs?
|
||
Not yet recruiting |
NCT05469295 -
CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
|
N/A | |
Withdrawn |
NCT01677650 -
Pharmacogenomics of Methadone in Spine Fusion Surgery
|
Phase 1 | |
Terminated |
NCT01852747 -
Comparison of Actifuse ABX and Local Bone in Spinal Surgery
|
Phase 4 | |
Not yet recruiting |
NCT05586685 -
Effect of Diaphragmatic Release on Upper Crossed Syndrome
|
N/A | |
Withdrawn |
NCT04757714 -
Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.
|
N/A | |
Completed |
NCT02180776 -
Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis
|
N/A |