StrokeCMNCT05830175
The Effects Of Cervical Mobilization
A study testing manual therapy for cervikal region and osteopathic suboccipital myofascial release technique in people with Stroke and Ischemic Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stroke, Ischemic Stroke, Chronic Stroke
- What is being tested?
- manual therapy for cervikal region and osteopathic suboccipital myofascial release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with stroke beetwen 30-70 ages had hemiparetik lezion
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects Of Cervikal Mobilization On Balance And Gait Parameters In Individuals With Stroke
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.
Read the 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.
- Conditions
- Stroke, Ischemic Stroke, Chronic Stroke
- Being tested
- manual therapy for cervikal region, osteopathic suboccipital myofascial release technique
- Keywords
- cervical mobilization, head posture, gait parameters, balance, stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy for cervikal regionOther
Also called mobilization of spine according to maitland concept
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.
osteopathic suboccipital myofascial release techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Craniovertebral angle assesment | Experimental | 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. Receives: Other: manual therapy for cervikal region; Other: osteopathic suboccipital myofascial release technique |
| Spatio-temporal gait analyz (LEGSystm) | Experimental | 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. Receives: Other: manual therapy for cervikal region; Other: osteopathic suboccipital myofascial release technique |
| Portable computerized kinesthetic balance device (SportKAT 550) | Experimental | 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. Receives: Other: manual therapy for cervikal region; Other: osteopathic suboccipital myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the procedure
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 .
Measured: during the procedure
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
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start15 Mar 2018
- Primary completion20 Apr 2021
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan KIZMAZ, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830175
- Sponsor's protocol ID
- AZİZPAMUKKALE
- Acronym
- CM
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Cervikal Mobilization On Balance And Gait Parameters In Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05830175
- Acronym / sponsor ID
- CM / AZİZPAMUKKALE
- Conditions
- Stroke, Ischemic Stroke, Chronic Stroke
- Keywords
- cervical mobilization, head posture, gait parameters, balance, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Craniovertebral angle assesment | Experimental | Other: manual therapy for cervikal region, Other: osteopathic suboccipital myofascial release techniqueCraniovertebral 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. |
| Spatio-temporal gait analyz (LEGSystm) | Experimental | Other: manual therapy for cervikal region, Other: osteopathic suboccipital myofascial release techniqueThe 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. |
| Portable computerized kinesthetic balance device (SportKAT 550) | Experimental | Other: manual therapy for cervikal region, Other: osteopathic suboccipital myofascial release techniqueThe 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with stroke beetwen 30-70 ages had hemiparetik lezion
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual therapy for cervikal regionAlso: mobilization of spine according to maitland conceptJoint 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. | Other | Craniovertebral angle assesment, Portable computerized kinesthetic balance device (SportKAT 550), Spatio-temporal gait analyz (LEGSystm) |
| osteopathic suboccipital myofascial release techniqueThe 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. | Other | Craniovertebral angle assesment, Portable computerized kinesthetic balance device (SportKAT 550), Spatio-temporal gait analyz (LEGSystm) |
Primary outcome
forward head posture
Time frame: during the procedure
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
Time frame: during the procedure
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
Time frame: during the procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy for cervikal region and osteopathic suboccipital myofascial release technique in people with Stroke and Ischemic Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forward head posture (time frame: during the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.