Investigation of the Effects of Exercise Program in Patients With Chiari Type 1 Malformation

NCT ID: NCT04073667

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2026-04-20

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.

Conditions

Arnold Chiari Malformation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Rehabilitation Group

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Specific Exercises:

a. Exercises for cervical flexors: Objectives are summarized below:

• To increase the endurance and strength of cervical flexors. b. Exercises for cervical extensors:
• Training of craniocervical extensors and rotators with the cervical spine in the neutral position, c. Axiocapular muscles;
• Teaching the correct scapular position, D. Postural correction exercises;
• Teaching the neutral spine position from the first treatment session, 2) Sensorimotor Exercises:

a. Joint position sense:

• Participants are trained to point their heads in different directions with the help of an illuminated band that is attached to the head with the eyes open at the beginning.

b. The sense of cervical movement, c. Oculomotor control exercises, 3) Balance and coordination exercises;

a. Balance training starts with static balance exercises and continues with dynamic balance exercises and walking exercises with different difficulty.

Late Rehabilitation Group

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Specific Exercises:

a. Exercises for cervical flexors: Objectives are summarized below:

• To increase the endurance and strength of cervical flexors. b. Exercises for cervical extensors:
• Training of craniocervical extensors and rotators with the cervical spine in the neutral position, c. Axiocapular muscles;
• Teaching the correct scapular position, D. Postural correction exercises;
• Teaching the neutral spine position from the first treatment session, 2) Sensorimotor Exercises:

a. Joint position sense:

• Participants are trained to point their heads in different directions with the help of an illuminated band that is attached to the head with the eyes open at the beginning.

b. The sense of cervical movement, c. Oculomotor control exercises, 3) Balance and coordination exercises;

a. Balance training starts with static balance exercises and continues with dynamic balance exercises and walking exercises with different difficulty.

Interventions

Exercise

Specific Exercises:

a. Exercises for cervical flexors: Objectives are summarized below:

• To increase the endurance and strength of cervical flexors. b. Exercises for cervical extensors:
• Training of craniocervical extensors and rotators with the cervical spine in the neutral position, c. Axiocapular muscles;
• Teaching the correct scapular position, D. Postural correction exercises;
• Teaching the neutral spine position from the first treatment session, 2) Sensorimotor Exercises:

a. Joint position sense:

• Participants are trained to point their heads in different directions with the help of an illuminated band that is attached to the head with the eyes open at the beginning.

b. The sense of cervical movement, c. Oculomotor control exercises, 3) Balance and coordination exercises;

a. Balance training starts with static balance exercises and continues with dynamic balance exercises and walking exercises with different difficulty.

Intervention Type: BEHAVIORAL

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. .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ceyhun Turkmen

Research Assisstant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ceyhun Türkmen

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Ceyhun Türkmen

Role: primary

ceyhun.turkmen@hacettepe.edu.tr

+905311017392

Other Identifiers

KA-19064

Identifier Type: -

Identifier Source: org_study_id