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Investigation of the Effects of Exercise on Patients With Chiari Malformation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04220541
Recruitment Status : Completed
First Posted : January 7, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Ceyhun Turkmen, Hacettepe University

Tracking Information
First Submitted Date  ICMJE January 4, 2020
First Posted Date  ICMJE January 7, 2020
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE July 6, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2020)
  • Neck Disability Index [ Time Frame: 6 weeks ]
    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.
  • Visual Analog Scale [ Time Frame: 1 week ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2020)
  • Berg Balance Scale [ Time Frame: 6 weeks ]
    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.
  • Posture Screen Mobile [ Time Frame: 24 hours ]
    PostureScreen Mobile allows you to accurately assess and analyze posture in seconds. Report provides front and side view photos clearly describing postural faults.
  • Short Form-36 [ Time Frame: 4 weeks ]
    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.
  • International Cooperative Ataxia Rating Scale [ Time Frame: 6 weeks ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Effects of Exercise on Patients With Chiari Malformation
Official Title  ICMJE Investigation of the Effects of Different Exercise Programs on Patients With Chiari Malformation Type 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chiari Malformation Type I
  • Proprioceptive Disorders
  • Coordination and Balance Disturbances
  • Syringomyelia
  • Basilar Invagination
  • Exercise Addiction
  • Atlanto-Axial Subluxation
Intervention  ICMJE Behavioral: Motor learning based exercise
Symptomatic exercise
Study Arms  ICMJE
  • Experimental: Motor learning based exercise group
    Intervention: Behavioral: Motor learning based exercise
  • Experimental: Symptomatic exercise group
    Intervention: Behavioral: Motor learning based exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2021)
16
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2020)
20
Actual Study Completion Date  ICMJE December 15, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04220541
Other Study ID Numbers  ICMJE KA-19155
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ceyhun Turkmen, Hacettepe University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hacettepe University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hacettepe University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP