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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05830175
Other study ID # AZIZPAMUKKALE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2018
Est. completion date July 27, 2022

Study information

Verified date April 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 27, 2022
Est. primary completion date April 20, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
manual therapy for cervikal region
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 technique
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.

Locations

Country Name City State
Turkey Aziz Dengiz Denizli Pamukkale

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. during the procedure
Primary 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 . during the procedure
Primary 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 during the procedure
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