Clinical trial NCT04220541: Investigation of the Effects of Exercise on Patients With Chiari Malformation
Official title: Investigation of the Effects of Different Exercise Programs on Patients With Chiari Malformation Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chiari Malformation Type I
Proprioceptive Disorders
Coordination and Balance Disturbances
Syringomyelia
Basilar Invagination
Exercise Addiction
Atlanto-Axial Subluxation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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,

Primary outcomes:
measure: Neck Disability Index
timeFrame: 6 weeks
measure: Visual Analog Scale
timeFrame: 1 week
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: Posture Screen Mobile
timeFrame: 24 hours
measure: Short Form-36
timeFrame: 4 weeks
measure: International Cooperative Ataxia Rating Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ceyhun Türkmen
Study officials:
References: