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Investigation of the Effects of Exercise on Patients With Chiari Malformation

Primary Purpose

Chiari Malformation Type I, Proprioceptive Disorders, Coordination and Balance Disturbances

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Motor learning based exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chiari Malformation Type I

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Ceyhun Türkmen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Motor learning based exercise group

Symptomatic exercise group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
January 4, 2020
Last Updated
January 22, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04220541
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chiari Malformation Type I, Proprioceptive Disorders, Coordination and Balance Disturbances, Syringomyelia, Basilar Invagination, Exercise Addiction, Atlanto-Axial Subluxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor learning based exercise group
Arm Type
Experimental
Arm Title
Symptomatic exercise group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Motor learning based exercise
Intervention Description
Symptomatic exercise
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
Time Frame
6 weeks
Title
Visual Analog Scale
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
6 weeks
Title
Posture Screen Mobile
Description
PostureScreen Mobile allows you to accurately assess and analyze posture in seconds. Report provides front and side view photos clearly describing postural faults.
Time Frame
24 hours
Title
Short Form-36
Description
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.
Time Frame
4 weeks
Title
International Cooperative Ataxia Rating Scale
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Ceyhun Türkmen
City
Ankara
ZIP/Postal Code
06080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of the Effects of Exercise on Patients With Chiari Malformation

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