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The Effects Of Cervical Mobilization (CM)

Primary Purpose

Stroke, Ischemic Stroke, Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manual therapy for cervikal region
osteopathic suboccipital myofascial release technique
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cervical mobilization, head posture, gait parameters, balance, stroke

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals diagnosed with stroke beetwen 30-70 ages had hemiparetik lezion Exclusion Criteria: Having previously diagnosed orthopedic diseases related to the spine Acute or chronic infections (including HIV) Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis) Have a history of whiplash or cervical surgery Having diseases that cause balance weakness (spinal cord damage, cerebellar ataxia, Parkinson's disease) Having another neurological disease Having a vision problem Receiving another treatment that will affect balance and walking Having a vision problem Receiving another treatment that will affect balance and walking

Sites / Locations

  • Aziz Dengiz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Craniovertebral angle assesment

Spatio-temporal gait analyz (LEGSystm)

Portable computerized kinesthetic balance device (SportKAT 550)

Arm Description

Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.

The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.

The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.

Outcomes

Primary Outcome Measures

forward head posture
Craniovertebral angle assesment Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.
gait parameters analyz
We evaluated the gait performance of the subjects using the spatio-temporal gait analysis device called LEGSystm developed by BioSensics. The device consists of two sensors that are placed with Velcro about 3-5 cm above the subject's ankle. The device is controlled from a computer through its software, and the raw data it collects is sent to the computer via Bluetooth in real-time. The software analyzes the raw data collected by the device and converts it into results. For evaluation, we used the Modified Get Up and Go Test , which is supported by the device. We recorded the average times of the test by repeating it twice. LEGSystm provides information on the length, duration, and speed of walking, as well as the time for standing up, turning, sitting, and the total time .
balance assesment
SporKAT examines the balance in 2 main parameters as static and dynamic, and 4 main parameters as forward-backward, right-left. SporKAT consists of a platform on the ground and a screen designed to face the patient, 1 meter away from the patient. Before the individual to be evaluated is taken to the platform, the pressure of the platform is adjusted, the increase in the pressure value stabilizes the platform and reduces its ability to disrupt the balance parameters

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
April 13, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05830175
Brief Title
The Effects Of Cervical Mobilization
Acronym
CM
Official Title
The Effects Of Cervikal Mobilization On Balance And Gait Parameters In Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale 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
The aim of this study is to examine the effects of cervical mobilization on balance and gait parameters in stroke individuals. Twenty-four stroke individuals aged 30-65 years, with a mini mental test score of 24 and above, and with a maximum score of 3 according to the modified rankin scale, were included in this study. Individuals were randomly divided into 2 groups as study (Bobath approach and cervical mobilization n=12) and control group (Bobath approach n=12). Demographic data, gait parameters, balance parameters and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Portable computerized kinesthetic balance device (SportKAT 550) and photometer, respectivelyThe evaluations were performed 2 times before and after the treatment.
Detailed Description
The aim of this study is to examine the effects of cervical mobilization on balance and gait parameters in stroke individuals. Twenty-four stroke individuals aged 30-65 years, with a mini mental test score of 24 and above, and with a maximum score of 3 according to the modified rankin scale, were included in this study. Individuals were randomly divided into 2 groups as study (Bobath approach and cervical mobilization n=12) and control group (Bobath approach n=12). Demographic data, gait parameters, balance parameters and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Portable computerized kinesthetic balance device (SportKAT 550) and photometer, respectivelyThe evaluations were performed 2 times before and after the treatment. In addition to the 1 hour Bobath treatment, the study group received 15 minutes of cervical region joint and soft tissue mobilizations 3 times per week along 4 weeks. The control group was treated with Bobath 3 days per week along 4 weeks and each session was 75 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Stroke, Chronic Stroke
Keywords
cervical mobilization, head posture, gait parameters, balance, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Demographic data, gait parameters, balance parameters and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Portable computerized kinesthetic balance device (SportKAT 550) and photometer, respectivelyThe evaluations were performed 2 times before and after the treatment. In addition to the 1 hour Bobath treatment, the study group received 15 minutes of cervical region joint and soft tissue mobilizations 3 times per week along 4 weeks. The control group was treated with Bobath 3 days per week along 4 weeks and each session was 75 minutes.
Masking
Participant
Masking Description
Basic randomization via SPSS v24.0 program
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Craniovertebral angle assesment
Arm Type
Experimental
Arm Description
Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.
Arm Title
Spatio-temporal gait analyz (LEGSystm)
Arm Type
Experimental
Arm Description
The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.
Arm Title
Portable computerized kinesthetic balance device (SportKAT 550)
Arm Type
Experimental
Arm Description
The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.
Intervention Type
Other
Intervention Name(s)
manual therapy for cervikal region
Other Intervention Name(s)
mobilization of spine according to maitland concept
Intervention Description
Joint mobilization: In the stroke individuals included in the mobilization group, Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization was applied with the Maitland method starting from the upper cervical region towards the lower cervical region, in 3 sets, 2 minutes and 1 minute rest.
Intervention Type
Other
Intervention Name(s)
osteopathic suboccipital myofascial release technique
Intervention Description
The patient lies comfortably in the supine position. The therapist's forearms are supported on the treatment table, with the metacarpophalangeal and proximal interphalangeal joints flexed to approximately 45 degrees. After the therapist places his hands on the area where the patient's suboccipital muscles connect the occiput, he asks the patient to relax and rest his head on his fingers. Therapist pays attention to positioning the fingertips in suboccipital area No traction is performed during this technique. The position is maintained until the patient is relaxed. This treatment takes approximately 3-4 minutes.
Primary Outcome Measure Information:
Title
forward head posture
Description
Craniovertebral angle assesment Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.
Time Frame
during the procedure
Title
gait parameters analyz
Description
We evaluated the gait performance of the subjects using the spatio-temporal gait analysis device called LEGSystm developed by BioSensics. The device consists of two sensors that are placed with Velcro about 3-5 cm above the subject's ankle. The device is controlled from a computer through its software, and the raw data it collects is sent to the computer via Bluetooth in real-time. The software analyzes the raw data collected by the device and converts it into results. For evaluation, we used the Modified Get Up and Go Test , which is supported by the device. We recorded the average times of the test by repeating it twice. LEGSystm provides information on the length, duration, and speed of walking, as well as the time for standing up, turning, sitting, and the total time .
Time Frame
during the procedure
Title
balance assesment
Description
SporKAT examines the balance in 2 main parameters as static and dynamic, and 4 main parameters as forward-backward, right-left. SporKAT consists of a platform on the ground and a screen designed to face the patient, 1 meter away from the patient. Before the individual to be evaluated is taken to the platform, the pressure of the platform is adjusted, the increase in the pressure value stabilizes the platform and reduces its ability to disrupt the balance parameters
Time Frame
during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals diagnosed with stroke beetwen 30-70 ages had hemiparetik lezion Exclusion Criteria: Having previously diagnosed orthopedic diseases related to the spine Acute or chronic infections (including HIV) Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis) Have a history of whiplash or cervical surgery Having diseases that cause balance weakness (spinal cord damage, cerebellar ataxia, Parkinson's disease) Having another neurological disease Having a vision problem Receiving another treatment that will affect balance and walking Having a vision problem Receiving another treatment that will affect balance and walking
Facility Information:
Facility Name
Aziz Dengiz
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20100
Country
Turkey

12. IPD Sharing Statement

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The Effects Of Cervical Mobilization

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