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This study will be conducted in Hacettepe University Faculty of Medicine Neurosurgery Department and Hacettepe University Faculty of Physical Therapy and Rehabilitation.
The study was designed as a randomized controlled trial. At the beginning of the study, demographic data and characteristics of the cases will be recorded. Patients will be evaluated in three different periods throughout the study. The first assessments will be performed on the first day after the patient's condition is appropriate after the surgical procedure for Type 1 CM. Following this evaluation, all patients will be divided into two groups using. a simple randomization method. The first group will be exercised for 6 weeks while the second group will not be intervened during this period and will be followed as a control group. Immediately after the exercise program administered to the first group after 6 weeks, both groups will undergo second assessments. After these assessment measures, the same exercise program in the first group will be applied to the second group only this time for 6 weeks. In the meantime, the first group will stop their exercise programs. After the 6-week exercise program of the second group has ended, both groups will be given the third assessment, the final assessment.
At the beginning of the study, demographic data, characteristics and disease information will be recorded.
The evaluations to be made are summarized below:
This study will be conducted in Hacettepe University Faculty of Medicine Neurosurgery Department and Hacettepe University Faculty of Physical Therapy and Rehabilitation.
The study was designed as a randomized controlled trial. At the beginning of the study, demographic data and characteristics of the cases will be recorded. Patients will be evaluated in three different periods throughout the study. The first assessments will be performed on the first day after the patient's condition is appropriate after the surgical procedure for Type 1 CM. Following this evaluation, all patients will be divided into two groups using. a simple randomization method. The first group will be exercised for 6 weeks while the second group will not be intervened during this period and will be followed as a control group. Immediately after the exercise program administered to the first group after 6 weeks, both groups will undergo second assessments. After these assessment measures, the same exercise program in the first group will be applied to the second group only this time for 6 weeks. In the meantime, the first group will stop their exercise programs. After the 6-week exercise program of the second group has ended, both groups will be given the third assessment, the final assessment.
"The study will be conducted in individuals aged 18-65 years who have been diagnosed with Type 1 CM by the physician and have been decided to undergo surgery for this diagnosis. In our study whose primary outcome parameters were determined as "Neck Disability Index" and "Visual Analogue Scale minimum, the minimum sample width required to reach 95% -99% power was six individuals in total. For various reasons (patient withdrawal, etc.), the rate of withdrawal from the study was predicted to be 25%. Accordingly, the study was decided to be conducted with a total of eight individuals.
Patients with a history of primary neurological disease other than Chiari Type 1 Malformation, severe cognitive impairment (> 24 from Mini-Mental State Assessment), peripheral vestibular problem, and history of orthopedic surgery will not be included in the study.
The data will be evaluated using SPSS for Windows 22.00. Descriptive statistics will be presented as a minimum, average, median, standard deviation, maximum and categorical variables for numerical variables and as percentages. The suitability of the variables to normal distribution will be examined by the Shapiro-Wilk normality test. Whether the groups (Group 1, Group 2) are similar in terms of gender will be examined by the Pearson Chi-Square Test when the prerequisites are met, and Fisher's exact test if not. By the cross-pass research design, the block, period, trial and sequence effects will be analyzed with a mixed effect model.
At the beginning of the study, demographic data, characteristics and disease information will be recorded.
The evaluations to be made are summarized below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Rehabilitation Group | Experimental | The first six weeks (1st-6th) will be followed as an exercise group and the second six weeks (7th-12th) will be followed as a control group without any intervention. |
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| Late Rehabilitation Group | Experimental | The first six weeks (1st-6th) will be followed as a control group without any intervention and the second six weeks (7th-12th) will be followed by exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Specific Exercises: a. Exercises for cervical flexors: Objectives are summarized below:
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Visual analogue scales (VAS) of sensory intensity and affective magnitude were validated as ratio scale measures for both chronic and experimental pain. | VAS was used to assess changes in chronic and experimental pain of individuals at 6th and 12th week of exercise intervention. |
| Neck Disability Index | The Neck Pain Disability Index (NDI) is a questionnaire that is commonly used in clinical trials to measure the functional status of patients with neck pain. The NDI was originally developed for assessing the functional status of patients with disabling neck pain, particularly whiplash-associated disorders. The NDI consists of 10 items addressing functional activities, such as personal care, lifting, reading, work, driving or cycling, sleeping and recreational activities, and a number of symptoms such as pain intensity, concentration, and headache.For each item, answering options range from 0 = no disability to 5 = total disability, resulting in a total range of scores from 0 to 50 points. | NDI was used to assess changes in functional status of patients with neck pain at 6th and 12th week of exercise intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | The Berg balance scale (BBS) assesses functional balance performance based on 14 items common to daily life. The maximum score that can be reached is 56 and each item possesses an ordinal scale of five alternatives ranging from 0 to 4 points. | BBS was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ceyhun Türkmen | Recruiting | Ankara | 06080 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001139 | Arnold-Chiari Malformation |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Sharpened Romberg Test | The subjects were instructed to stand barefoot with the dominant foot just in front of the other (tandem stand, i.e., heel to toe), arms folded across the chest, with eyes open in the first trial, and with eyes closed in a second trial. The score was the number of seconds the subject maintained the test position. Timing started when the subject assumed the proper position and indicated she was ready. Timing stopped if the subject moved either foot from the proper position, opened her eyes in the eyes closed trial, or reached the 60 second time limit. | Sharpened Romberg Test was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention. |
| Short Form 36 | The SF36 is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems (four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). | Short Form 36 was used to assess changes in quality of life at 6th and 12th week of exercise intervention. |
| Barthel Daily Living Activity Index | Barthel Index of Activities of Daily Living. The Barthel Index (BI) is one of the most widely used rating scales for the measurement of activity limitations in patients with neuromuscular and musculoskeletal conditions in an inpatient rehabilitation setting. | Short Form 36 was used to assess changes in daily living activities at 6th and 12th week of exercise intervention. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |