NCT05830175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

3.1 years

First QC Date

March 20, 2023

Last Update Submit

April 13, 2023

Conditions

Keywords

cervical mobilizationhead posturegait parametersbalancestroke

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

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.

Other: manual therapy for cervikal regionOther: 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.

Other: manual therapy for cervikal regionOther: 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.

Other: manual therapy for cervikal regionOther: osteopathic suboccipital myofascial release technique

Interventions

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.

Also known as: mobilization of spine according to maitland concept
Craniovertebral angle assesmentPortable computerized kinesthetic balance device (SportKAT 550)Spatio-temporal gait analyz (LEGSystm)

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.

Craniovertebral angle assesmentPortable computerized kinesthetic balance device (SportKAT 550)Spatio-temporal gait analyz (LEGSystm)

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with stroke beetwen 30-70 ages had hemiparetik lezion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aziz Dengiz

Denizli, Pamukkale, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Basic randomization via SPSS v24.0 program
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc. Phsyioterapist

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 26, 2023

Study Start

March 15, 2018

Primary Completion

April 20, 2021

Study Completion

July 27, 2022

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations