Investigation of the Effects of Exercise on Patients With Chiari Malformation

NCT04220541 | Completed

• 1 other identifier: KA-19155
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Berg Balance Scale

  6 weeks

• Posture Screen Mobile

  24 hours

• Short Form-36

  4 weeks

• International Cooperative Ataxia Rating Scale

  6 weeks

Study Arms (2)

Motor learning based exercise group

EXPERIMENTAL

Behavioral: Motor learning based exercise

Symptomatic exercise group

EXPERIMENTAL

Behavioral: Motor learning based exercise

Interventions

Motor learning based exercise BEHAVIORAL

Symptomatic exercise

Motor learning based exercise group; Symptomatic exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ceyhun Türkmen

Ankara, 06080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arnold-Chiari Malformation; Somatosensory Disorders; Syringomyelia

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 7, 2020
• Study Start: July 6, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 15, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)