Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04220541
Other study ID # KA-19155
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 6, 2020
Est. completion date December 15, 2020

Study information

Verified date January 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chiari Malformation (CM) is a posterior brain anomaly caused by the displacement of the brain stem and cerebellum into the cervical spinal canal. There are 8 types of Chiari malformations described today that vary according to the severity of the anomaly. In CM Type 1, cerebrospinal fluid (CSF) circulation deteriorated along with the foramen magnum and the cerebellar tonsillar decreased to at least 5 mm below the foramen magnum. Depending on this situation, headache, cerebellar findings, muscle strength, and sensory loss and so on. and adversely affect the daily life of the patient. When establishing an exercise program for the symptoms of CM type 1, it should be taken into consideration that somatosensory, visual, vestibular system and cerebellum are in close relationship with each other and balance and coordination result from this close relationship. When the literature is reviewed for exercise programs aimed at reducing instability in the cervical region, it is seen that 80% of the stability of the cervical spine originates from the muscular system and its importance in the treatment process is being investigated more and more day by day. However, no randomized controlled study was performed on these subjects. This study was planned to investigate the effects of two different exercise programs on pain, balance, coordination, proprioception, functional capacity, body posture, daily life activities and quality of life. The study was planned to involve at least 20 individuals with CM Type 1 who were not surgical indications in the 18-65 age range. The study was designed as a randomized, self-controlled study. Demographic data and characteristics of the subjects who meet the inclusion criteria and agree to participate in the study will be recorded at the beginning of the study. Patients will be evaluated in two different time periods. The first evaluations will be performed on the first day when patients are referred to rehabilitation by the physician. Following this assessment, all patients will be assigned numbers, which will be divided into two groups using a simple randomization method in the form of drawing lots. A total of 18 sessions 3 times a week for six weeks, the first group will receive symptomatic exercise program and the second group will focus on the deep muscles in the cervical region, especially the stabilizer, and a "Motor learning-based" exercise program that includes gradual control of these muscles. After 6 weeks, the first evaluations will be repeated in both groups.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 15, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - The study was planned to involve at least 20 individuals with CM Type 1 who were not surgical indications in the 18-65 age range. Exclusion Criteria: - Motor type defect due to CM Type 1, - Presence of primary neurological disease other than CM Type 1, severe cognitive impairment (> 24 from the Mini Mental State Assessment), - peripheral vestibular problem and history of orthopedic surgery, - patients who had musculoskeletal problems in the last 6 months and who received physiotherapy rehabilitation program in the last 6 months,

Study Design


Intervention

Behavioral:
Motor learning based exercise
Symptomatic exercise

Locations

Country Name City State
Turkey Ceyhun Türkmen Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck Disability Index The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. ... Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. 6 weeks
Primary Visual Analog Scale A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. 1 week
Secondary Berg Balance Scale The BBS is a qualitative measure that assesses balance via performing functional activities such as reaching, bending, transferring, and standing that incorporates most components of postural control: sitting and transferring safely between chairs; standing with feet apart, feet together, in single-leg stance, and feet in the tandem Romberg position with eyes open or closed; reaching and stooping down to pick something off the floor. Each item is scored along a 5-point scale, ranging from 0 to 4, each grade with well-established criteria. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. 6 weeks
Secondary Posture Screen Mobile PostureScreen Mobile allows you to accurately assess and analyze posture in seconds. Report provides front and side view photos clearly describing postural faults. 24 hours
Secondary Short Form-36 As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. 4 weeks
Secondary International Cooperative Ataxia Rating Scale The International Cooperative Ataxia Rating Scale (ICARS) is an outcome measure that was created in 1997 by the Committee of the World Federation of Neurology with the goal of standardizing the quantification of impairment due to cerebellar ataxia. The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.
Intended Population
6 weeks
See also
  Status Clinical Trial Phase
Completed NCT03312062 - Influence of Foam Rolling on Elbow Proprioception, Strength, and Functional Motor Performance N/A
Active, not recruiting NCT05663541 - Validity and Reliability of Lower Extremity Position Test in Patients With Multiple Sclerosis
Completed NCT05435040 - Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits N/A
Completed NCT05087719 - Effects of Proprioceptive Activities on Hand Function in Chronic Stroke Patients N/A
Completed NCT05405881 - Validity and Reliability of the PROprioception Measurement Tool (PROMT) N/A
Recruiting NCT03881930 - Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy N/A
Completed NCT03852199 - A Validation Study of Force Sense Measurement
Completed NCT05916872 - Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients. N/A
Completed NCT04440293 - Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain N/A
Completed NCT05287802 - The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis N/A
Completed NCT04210518 - Balance Training With Stroboscopic Vision N/A
Terminated NCT02746523 - Effects of Multiple Concussions in Retired NHL Players N/A
Withdrawn NCT04289584 - Exercises With Elastic Bands and Stability in Proprioception and Strength in Female Athletes of Taekwondo N/A
Completed NCT03871738 - Proprioception in the Improvement of Sports Performance in Long Jumpers. N/A
Completed NCT03837041 - Evaluation of Proprioception N/A
Completed NCT02804685 - Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players N/A
Not yet recruiting NCT01677429 - The Assessment and Treatment of Balance Impairment Using Virtual Reality (VR) in Panic Disorder Patients N/A
Not yet recruiting NCT04930718 - Thumb and Wrist Proprioception Exercises. N/A
Recruiting NCT03298243 - Use of Sensory Substitution to Improve Arm Control After Stroke N/A
Completed NCT05707715 - Comfort and Support Values of Different Pillow Designs