Clinical trial NCT04073667: Investigation of the Effects of Exercise Program in Patients With Chiari Type 1 Malformation
Official title: Investigation of the Effects of Exercise Program Applied on Postoperative Period in Patients With Chiari Type 1 Malformation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arnold Chiari Malformation
Keywords: balance
proprioception
exercise
cervical region
chiari malformation
rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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:

* Visual Analogue Scale, pain threshold and pain tolerance tests, Neck Disability Index, for the determination of pain level in the neck region and throughout the body
* Cervical range of motion (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3) device for the evaluation of the cervical region.
* Berg Balance Scale for evaluation of performance-based balance,
* Timed Rise Walk Test, Sharpened Romberg test and "8" shaped walk test (F8WT) for evaluation of fall risk, static and dynamic balance,
* The International Ataxia Assessment Scale (ICARS) for coordination,
* Grip Ability Test (GAT) for the assessment of fine motor skill in the upper extremity,
* Posture evaluation,
* Eating Assessment Tool (EAT-10) for evaluation of swallowing function
* For daily living activities, Barthel Daily Living Activities Index,
* For the quality of life, the Short Form 36 questionnaire will be used.

Detailed description: 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:

* Visual Analogue Scale, pain threshold and pain tolerance tests, Neck Disability Index, for the determination of pain level in the neck region and throughout the body
* Cervical range of motion (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3) device for the evaluation of the cervical region.
* Berg Balance Scale for evaluation of performance-based balance,
* Timed Rise Walk Test, Sharpened Romberg test and "8" shaped walk test (F8WT) for evaluation of fall risk, static and dynamic balance,
* The International Ataxia Assessment Scale (ICARS) for coordination,
* Grip Ability Test (GAT) for the assessment of fine motor skill in the upper extremity,
* Posture evaluation,
* Eating Assessment Tool (EAT-10) for evaluation of swallowing function
* For daily living activities, Barthel Daily Living Activities Index,
* For the quality of life, the Short Form 36 questionnaire will be used.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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. .

Primary outcomes:
measure: Visual Analog Scale
timeFrame: VAS was used to assess changes in chronic and experimental pain of individuals at 6th and 12th week of exercise intervention.
measure: Neck Disability Index
timeFrame: NDI was used to assess changes in functional status of patients with neck pain at 6th and 12th week of exercise intervention.
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: BBS was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.
measure: Sharpened Romberg Test
timeFrame: Sharpened Romberg Test was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.
measure: Short Form 36
timeFrame: Short Form 36 was used to assess changes in quality of life at 6th and 12th week of exercise intervention.
measure: Barthel Daily Living Activity Index
timeFrame: Short Form 36 was used to assess changes in daily living activities at 6th and 12th week of exercise intervention.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ceyhun Türkmen
Study officials:
References: