Back to resultsEvaluation of Spine Posture, Trunk Position Sense and Gait in Axial Spondyloarthritis Patients
Primary Purpose
Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Gait parameters
Spine posture
Trunk position sense
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-radiographic Axial Spondyloarthritis focused on measuring Ankylosing Spondylitis,, Non-radiographic Axial Spondyloarthritis, Spine posture, Gait
Eligibility Criteria
Inclusion Criteria:
For AS and nr-axSpA;
- Diagnosed with AS and nr-axSpA by a rheumatologist according to ASAS criteria,
- Diagnosed with AS and nr-axSpA at least two years ago,
- Volunteer to participate in the study,
- Individuals between the ages of 18-65 will be included in the study.
For Healthy volunteers;
- Volunteer to participate in the study,
- Individuals between the ages of 18-65 will be included in the study.
Exclusion Criteria:
For AS and nr-axSpA;
- Having orthopedic problems in the lower extremity,
- Locomotor disorders (fractures and prostheses) and / or osteoporosis,
- Having a history of lower extremity and spine surgery,
- Having neurological and cognitive problems,
- Having vision and hearing problems,
- Regular exercise,
- Individuals with kyphosis above 50 degrees will be excluded from the study.
For Healthy volunteers;
- Having any musculoskeletal, neurological and rheumatological diseases,
- Having any condition (advanced respiratory or orthopedic problems, fracture, sprain or spine surgery) that will prevent the evaluation,
- Regular exercise,
- Individuals who do not agree to participate in the study will be excluded from the study.
Sites / Locations
- Yasemin AkkubakRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ankylosing Spondylitis
Non-radiographic Axial Spondyloarthritis
Healthy individuals
Arm Description
Study group
Study group
Control group
Outcomes
Primary Outcome Measures
Gait analyses
The spatiotemporal parameters of gait will be evaluated using the Diagnostic Support Baropodometer Footscan® 3D system. The spatial parameters of gait, step length (cm), step width (cm) and foot angle (degrees) and the temporal parameters of gait, speed (m/min), cadence (step/min) and stance time (sec) will be recorded. For evaluating of the plantar pressure distribution will be used the Diagnostic Support Baropodometer Footscan® 3D system, besides the dynamic evaluation and recording of the spatiotemporal parameters, the data on the total load on the forefoot, midfoot and hindfoot; the average pressure; and the distribution of load in the forefoot, midfoot and hindfoot will be also obtained.
Spine posture
Thoracic and lumbar curvature tests will be performed with a digital inclinometer (Acumar®, Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). For throcic curvature, the 7th cervical vertebra, the most prominent spinous process, and the sacrum will be used as reference points to palpate the spinal processes of T1-T2 and T12-L1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T1-T2 and T12-L1. The angle on the digital display of the inclinometer will be recorded as degree. The mean of three successful measurements will be used. For lumbar curvature, the sacrum and iliac crest will be used as reference points to palpate the spinal processes of T12-L1 and L5-S1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T12-L1 and L5-S1. The angle on the digital display of the inclinometer will be recorded in degrees.
Trunk position sense
Trunk position sense, as indicated by trunk reposition errors (TRE), will be assessed with a digital inclinometer (Acumar®,Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). The participants will be asked to stand upright in a comfortable position. The inferior angle of the scapula will first palpated as a bony landmark to find the spinousprocess of T4. After the placement of the inclinometer over the spinous process of T4, the participants will be asked to flex the trunk approximately 30° in the sagittal plane and hold this position for 3 s in eyes closed position. After returning to the neutral upright position, they will be asked to duplicate the previously attained position and held the position for 3 s for five times in a row. The absolute differences between the original position and the other five attempts will be recorded. The highest and lowest scores will be discarded and the mean of the tree remaining scores will be used to assess the trunk position sense.
Secondary Outcome Measures
Stabilometric test
In the stabilometric evaluation, a STABYLO platform, which is produced by Diagnostic Support, will be used. A 40x80 cm sensing surface with 12,800 active sensors is used for the examination of body oscillations in the upright position (the foot at 30°) and for the evaluation of body strategies in a specific time frame (maximum 51.2 sec) by maintaining the eyes in the open and closed positions. In the present study, the body oscillations with open and closed eyes will be calculated as an area in cm².
Bath Ankylosing Spondylitis Metrology Index
Spinal mobility will assessed and scored by Bath Ankylosing Spondylitis Metrology Index (BASMI). There are five measurements including lateral lumbar flexion, tragus-to-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation according to the index. Each subscale is scored between 0 and 10. All points are then averaged to calculate total score. Higher values represent worse outcomes.
Bath Ankylosing Spondylitis Disease Activity Index
Bath Ankylosing Spondylitis Disease Activity Index which consists of 6 questions will be used to evaluate disease activity. BASDAI is a composite index, consisting of an assessment on a 10 cm horizontal visual analog scale of fatigue, axial pain, peripheral pain, enthesopathy and stiffness. Fifth and sixth questions are averaged. Addition to this score, other questions are averaged. Total score is between 0 and 10. Higher score represent worse outcome.
Lumbopelvic stabilization assessment
Lumbopelvic stabilization will be evaluated by a pressure biofeedback unit (Stabilizer Pressure Biofeedback Unit, Chattanooga Group Inc., Hixson, TN, USA). The participant will be positioned in crook lying position and the pressure cell will be placed under the lumbar spine and inflate to the baseline pressure of 40 mmHg. The participant will be instructed to perform abdominal hollowing without moving their spine or pelvis, and to hold the contraction for 10 seconds monitored by using a digital watch. The change in pressure during abdominal hollowing will be repeated three times and the mean of all the measurements will be recorded.
Disease-Related Functional Status
Bath Ankylosing Spondylitis Functional Index (BASFI) was used to assess the functional status. BASFI includes 10 items which eight of them related to physical limitations, and two of them inquiry about the coping strategies in daily life. Each item is scored between 0 and 10 (0: easy, 10: impossible) by the patient. The total score is calculated by summing all the items and dividing them to 10. Higher scores indicate a higher level of functional limitations.
Disease-Related Quality of Life
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) will be used to evaluate the disease-related quality of life. It includes 18 yes/no questions. Each yes answer is scored as onepoint. ASQoL is a valid and reliable tool for both clinical purposes and scientific research. Higher scores indicate poorer quality of life.
Musculoskeletal Health Questionnaire
The Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) is composed of 14 items which evaluate the holistic impact of different musculoskeletal diseases on a person's health over the last two weeks, regardless of the location of their musculoskeletal pain. These items consist of the severity of stiffness/pain (during the day and night), physical function (washing/dressing and walking), level of physical activity, symptom interference (with daily routine, work and social activities), needing help, trouble with sleeping, low energy/fatigue level, emotional well-being (mood and anxiety), understanding of treatment and diagnosis, confidence to self-management, independence and general impact of symptoms.
Full Information
NCT ID
NCT05038189
First Posted
August 31, 2021
Last Updated
September 13, 2021
Sponsor
Necmettin Erbakan University
Collaborators
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT05038189
Brief Title
Evaluation of Spine Posture, Trunk Position Sense and Gait in Axial Spondyloarthritis Patients
Official Title
Comparison of Spine Posture, Trunk Position Sense and Gait Characteristics Among Different Sub-types of Axial Spondyloarthritis Patients and Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University
Collaborators
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Axial Spondyloarthritis (Ax-SpA) are chronic systemic inflammatory rheumatological diseases characterized by axial skeletal involvement and enthesitis. Sacroiliitis is the most prominent sign of the disease. The International Society for the Evaluation of Spondyloarthritis created a new classification for Ax-SpA in 2009. According to this classification, Ax-SpA; It is divided into two groups as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
With the emergence of the term nr-axSpA, studies have begun to compare AS and nr-axSpA in terms of genetic, epidemiological and clinical features, treatment needs and response to treatment.However, more studies are needed to better understand the clinical features and symptoms of nr-axSpA patients.
The aim of this study was to determine the clinical features of patients with nr-axSpA and AS; To evaluate spine posture, trunk position sense and gait parameters, and also to compare these results with healthy individuals.
Detailed Description
There are no studies comparing spine posture, trunk position sense and gait parameters in patients with nr-axSpA and AS. It is important to determine the changes that occur in nr-axSpA patients in the early period. At the same time, taking the necessary precautions and following these patients with the rehabilitation process can ensure that the radiographic development is delayed or not at all in the future.
Hypotheses:
H1: Trunk position sense is different from each other in individuals with Nr-axSpA and AS.
H2: Spatio-temporal features of gait are different in individuals with Nr-axSpA and AS.
H3: Plantar pressure distribution is different in individuals with Nr-axSpA and AS.
The Location of the Research: The research is carried out in Konya Necmettin Erbakan University Meram Faculty of Medicine, Rheumatology Department. After obtaining the permission of the ethics committee, official permission was obtained from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician to conduct the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis,, Non-radiographic Axial Spondyloarthritis, Spine posture, Gait
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ankylosing Spondylitis
Arm Type
Experimental
Arm Description
Study group
Arm Title
Non-radiographic Axial Spondyloarthritis
Arm Type
Experimental
Arm Description
Study group
Arm Title
Healthy individuals
Arm Type
Experimental
Arm Description
Control group
Intervention Type
Diagnostic Test
Intervention Name(s)
Gait parameters
Other Intervention Name(s)
Trunk position sense, Spine posture
Intervention Description
Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spine posture
Other Intervention Name(s)
Gait parameters, Trunk position sense
Intervention Description
Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
Intervention Type
Diagnostic Test
Intervention Name(s)
Trunk position sense
Other Intervention Name(s)
Gait parameters, Spine posture
Intervention Description
Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
Primary Outcome Measure Information:
Title
Gait analyses
Description
The spatiotemporal parameters of gait will be evaluated using the Diagnostic Support Baropodometer Footscan® 3D system. The spatial parameters of gait, step length (cm), step width (cm) and foot angle (degrees) and the temporal parameters of gait, speed (m/min), cadence (step/min) and stance time (sec) will be recorded. For evaluating of the plantar pressure distribution will be used the Diagnostic Support Baropodometer Footscan® 3D system, besides the dynamic evaluation and recording of the spatiotemporal parameters, the data on the total load on the forefoot, midfoot and hindfoot; the average pressure; and the distribution of load in the forefoot, midfoot and hindfoot will be also obtained.
Time Frame
6 months
Title
Spine posture
Description
Thoracic and lumbar curvature tests will be performed with a digital inclinometer (Acumar®, Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). For throcic curvature, the 7th cervical vertebra, the most prominent spinous process, and the sacrum will be used as reference points to palpate the spinal processes of T1-T2 and T12-L1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T1-T2 and T12-L1. The angle on the digital display of the inclinometer will be recorded as degree. The mean of three successful measurements will be used. For lumbar curvature, the sacrum and iliac crest will be used as reference points to palpate the spinal processes of T12-L1 and L5-S1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T12-L1 and L5-S1. The angle on the digital display of the inclinometer will be recorded in degrees.
Time Frame
6 months
Title
Trunk position sense
Description
Trunk position sense, as indicated by trunk reposition errors (TRE), will be assessed with a digital inclinometer (Acumar®,Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). The participants will be asked to stand upright in a comfortable position. The inferior angle of the scapula will first palpated as a bony landmark to find the spinousprocess of T4. After the placement of the inclinometer over the spinous process of T4, the participants will be asked to flex the trunk approximately 30° in the sagittal plane and hold this position for 3 s in eyes closed position. After returning to the neutral upright position, they will be asked to duplicate the previously attained position and held the position for 3 s for five times in a row. The absolute differences between the original position and the other five attempts will be recorded. The highest and lowest scores will be discarded and the mean of the tree remaining scores will be used to assess the trunk position sense.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Stabilometric test
Description
In the stabilometric evaluation, a STABYLO platform, which is produced by Diagnostic Support, will be used. A 40x80 cm sensing surface with 12,800 active sensors is used for the examination of body oscillations in the upright position (the foot at 30°) and for the evaluation of body strategies in a specific time frame (maximum 51.2 sec) by maintaining the eyes in the open and closed positions. In the present study, the body oscillations with open and closed eyes will be calculated as an area in cm².
Time Frame
6 months
Title
Bath Ankylosing Spondylitis Metrology Index
Description
Spinal mobility will assessed and scored by Bath Ankylosing Spondylitis Metrology Index (BASMI). There are five measurements including lateral lumbar flexion, tragus-to-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation according to the index. Each subscale is scored between 0 and 10. All points are then averaged to calculate total score. Higher values represent worse outcomes.
Time Frame
6 months
Title
Bath Ankylosing Spondylitis Disease Activity Index
Description
Bath Ankylosing Spondylitis Disease Activity Index which consists of 6 questions will be used to evaluate disease activity. BASDAI is a composite index, consisting of an assessment on a 10 cm horizontal visual analog scale of fatigue, axial pain, peripheral pain, enthesopathy and stiffness. Fifth and sixth questions are averaged. Addition to this score, other questions are averaged. Total score is between 0 and 10. Higher score represent worse outcome.
Time Frame
6 months
Title
Lumbopelvic stabilization assessment
Description
Lumbopelvic stabilization will be evaluated by a pressure biofeedback unit (Stabilizer Pressure Biofeedback Unit, Chattanooga Group Inc., Hixson, TN, USA). The participant will be positioned in crook lying position and the pressure cell will be placed under the lumbar spine and inflate to the baseline pressure of 40 mmHg. The participant will be instructed to perform abdominal hollowing without moving their spine or pelvis, and to hold the contraction for 10 seconds monitored by using a digital watch. The change in pressure during abdominal hollowing will be repeated three times and the mean of all the measurements will be recorded.
Time Frame
6 months
Title
Disease-Related Functional Status
Description
Bath Ankylosing Spondylitis Functional Index (BASFI) was used to assess the functional status. BASFI includes 10 items which eight of them related to physical limitations, and two of them inquiry about the coping strategies in daily life. Each item is scored between 0 and 10 (0: easy, 10: impossible) by the patient. The total score is calculated by summing all the items and dividing them to 10. Higher scores indicate a higher level of functional limitations.
Time Frame
6 months
Title
Disease-Related Quality of Life
Description
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) will be used to evaluate the disease-related quality of life. It includes 18 yes/no questions. Each yes answer is scored as onepoint. ASQoL is a valid and reliable tool for both clinical purposes and scientific research. Higher scores indicate poorer quality of life.
Time Frame
6 months
Title
Musculoskeletal Health Questionnaire
Description
The Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) is composed of 14 items which evaluate the holistic impact of different musculoskeletal diseases on a person's health over the last two weeks, regardless of the location of their musculoskeletal pain. These items consist of the severity of stiffness/pain (during the day and night), physical function (washing/dressing and walking), level of physical activity, symptom interference (with daily routine, work and social activities), needing help, trouble with sleeping, low energy/fatigue level, emotional well-being (mood and anxiety), understanding of treatment and diagnosis, confidence to self-management, independence and general impact of symptoms.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For AS and nr-axSpA;
Diagnosed with AS and nr-axSpA by a rheumatologist according to ASAS criteria,
Diagnosed with AS and nr-axSpA at least two years ago,
Volunteer to participate in the study,
Individuals between the ages of 18-65 will be included in the study.
For Healthy volunteers;
Volunteer to participate in the study,
Individuals between the ages of 18-65 will be included in the study.
Exclusion Criteria:
For AS and nr-axSpA;
Having orthopedic problems in the lower extremity,
Locomotor disorders (fractures and prostheses) and / or osteoporosis,
Having a history of lower extremity and spine surgery,
Having neurological and cognitive problems,
Having vision and hearing problems,
Regular exercise,
Individuals with kyphosis above 50 degrees will be excluded from the study.
For Healthy volunteers;
Having any musculoskeletal, neurological and rheumatological diseases,
Having any condition (advanced respiratory or orthopedic problems, fracture, sprain or spine surgery) that will prevent the evaluation,
Regular exercise,
Individuals who do not agree to participate in the study will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YASEMİN AKKUBAK, Res. Asiss.
Phone
+905514327535
Email
yakkubak@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
TÜLİN DÜGER, Prof.
Phone
+905324714440
Email
tduger@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADEM KÜÇÜK, Dr.
Organizational Affiliation
Necmettin Erbakan University, Faculty of Medicine, Meram/KONYA/TURKEY
Official's Role
Study Chair
Facility Information:
Facility Name
Yasemin Akkubak
City
Konya
State/Province
Meram
ZIP/Postal Code
42100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YASEMİN AKKUBAK, Res. Assist.
Phone
05514327535
Email
yakkubak@gmail.com
First Name & Middle Initial & Last Name & Degree
ADEM KÜÇÜK, Dr.
Phone
05514327535
Email
drademk@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Spine Posture, Trunk Position Sense and Gait in Axial Spondyloarthritis Patients
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