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

NCT04073667 | Recruiting

• 1 other identifier: KA-19064
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Arnold Chiari Malformation

Keywords

balance; proprioception; exercise; cervical region; chiari malformation; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• Berg Balance Scale

  BBS was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.

• Sharpened Romberg Test

  Sharpened Romberg Test was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.

• Short Form 36

  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

  Short Form 36 was used to assess changes in daily living activities at 6th and 12th week of exercise intervention.

Study Arms (2)

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.

Behavioral: Exercise

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.

Behavioral: Exercise

Interventions

Exercise 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.

Early Rehabilitation Group; Late Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. .

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ceyhun Türkmen

Ankara, 06080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arnold-Chiari Malformation; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assisstant

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: November 20, 2019
• Primary Completion: October 20, 2025
• Study Completion: April 20, 2026
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

TU (1)