Arnold Chiari MalformationNCT04073667
Investigation of the Effects of Exercise Program in Patients With Chiari Type 1 Malformation
A study testing Exercise in people with Arnold Chiari Malformation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arnold Chiari Malformation
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. .
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ceyhun Türkmen
Ankara, 06080
Ceyhun Türkmen, +905311017392, ceyhun.turkmen@hacettepe.edu.tr
Nezire Köse
About this study
Official title: Investigation of the Effects of Exercise Program Applied on Postoperative Period in Patients With Chiari Type 1 Malformation
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.
Read more
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.
Read the 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
- Being tested
- Exercise
- Keywords
- balance, proprioception, exercise, cervical region, chiari malformation, rehabilitation
- Medical subject headings
- Arnold-Chiari Malformation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Specific Exercises:
- 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:
- 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.
- The sense of cervical movement, c. Oculomotor control exercises, 3) Balance and coordination exercises;
- Balance training starts with static balance exercises and continues with dynamic balance exercises and walking exercises with different difficulty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: BBS was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.
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.
Measured: 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).
Measured: 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.
Measured: Short Form 36 was used to assess changes in daily living activities at 6th and 12th week of exercise intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start20 Nov 2019
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arnold Chiari MalformationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Turkmen, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073667
- Sponsor's protocol ID
- KA-19064
- Status last verified
- Mar 2022
- First submitted
- 27 Aug 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Exercise Program Applied on Postoperative Period in Patients With Chiari Type 1 Malformation
- ClinicalTrials.gov ID
- NCT04073667
- Acronym / sponsor ID
- KA-19064
- Conditions
- Arnold Chiari Malformation
- Keywords
- balance, proprioception, exercise, cervical region, chiari malformation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Rehabilitation Group | Experimental | Behavioral: ExerciseThe 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. |
| Late Rehabilitation Group | Experimental | Behavioral: ExerciseThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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. .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSpecific 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. | Behavioural | Early Rehabilitation Group, Late Rehabilitation Group |
Primary outcome
Visual Analog Scale
Time frame: VAS was used to assess changes in chronic and experimental pain of individuals at 6th and 12th week of exercise intervention.
Visual analogue scales (VAS) of sensory intensity and affective magnitude were validated as ratio scale measures for both chronic and experimental pain.
Neck Disability Index
Time frame: NDI was used to assess changes in functional status of patients with neck pain at 6th and 12th week of exercise intervention.
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.
4 secondary outcomes
Berg Balance Scale
Time frame: BBS was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.
Sharpened Romberg Test
Time frame: Sharpened Romberg Test was used to assess changes in functional balance performance at 6th and 12th week of exercise intervention.
Short Form 36
Time frame: 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
Time frame: Short Form 36 was used to assess changes in daily living activities at 6th and 12th week of exercise intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Arnold Chiari Malformation, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: VAS was used to assess changes in chronic and experimental pain of individuals at 6th and 12th week of exercise intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.