Investigation of the Effects of Exercise on Patients With Chiari Malformation

NCT ID: NCT04220541

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2020-12-15

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.

Conditions

Chiari Malformation Type I; Proprioceptive Disorders; Coordination and Balance Disturbances; Syringomyelia; Basilar Invagination; Exercise Addiction; Atlanto-Axial Subluxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Motor learning based exercise group

Group Type: EXPERIMENTAL

Motor learning based exercise

Intervention Type: BEHAVIORAL

Symptomatic exercise

Symptomatic exercise group

Group Type: EXPERIMENTAL

Motor learning based exercise

Intervention Type: BEHAVIORAL

Symptomatic exercise

Interventions

Motor learning based exercise

Symptomatic exercise

Intervention Type: BEHAVIORAL

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ceyhun Turkmen

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ceyhun Türkmen

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA-19155

Identifier Type: -

Identifier Source: org_study_id