Parkinson DiseaseNCT03854747
The Effect of Cervical Spinal Stabilization Exercises in Patients With Parkinson's Disease
A study testing cervical spinal stabilization exercise in people with Parkinson Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease (PH); it occurs due to dopamine deficiency due to the loss of dopaminergic neurons in a degenerative process in the substantia nigra found in the middle brain; resting tremor, bradykinesia, trunk and extremities rigidity, mask facial and postural instability characterized by a neurodegenerative… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- cervical spinal stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2019to 2 Aug 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease,
- Having planned a traditional physiotherapy program for Parkinson's disease and referring to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department,
- 40 to 80 years old,
- According to Hoehn-Yahr scale to be in stage 2 or 3,
- Having scored 30 points above the posture evaluation
- Postural disorder in the femoral region, but the absence of structural disorder (congenital spinal deformities in medical evaluations prior to the study, structural disorders caused by other diseases should be determined that the spine does not have problems),
Show all 10Show fewer
- 26 points higher than the mini-mental test,
- Disease duration is 3 years and above,
- The absence of any other neurological disease other than vestibular and / or Parkinson's, which may affect muscle strength, balance and coordination,
- Spinal colon and lower extremity musculoskeletal system, which may affect the stabilization of any surgery has been identified as.
Who cannot join
- Volunteers who do not comply with the inclusion criteria will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Cervical Spinal Stabilization Exercises on Spinal Posture, Cervical Proprioception and Postural Instability in Patients With Parkinson's Disease
Parkinson's disease (PH); it occurs due to dopamine deficiency due to the loss of dopaminergic neurons in a degenerative process in the substantia nigra found in the middle brain; resting tremor, bradykinesia, trunk and extremities rigidity, mask facial and postural instability characterized by a neurodegenerative disease. These findings are basic and also motor symptoms of Parkinson's Disease. Non-motor symptoms include many problems ranging from autonomic dysfunction to sensory symptoms.
Treatment of Parkinson's disease requires a multidisciplinary approach such as medical treatment, physiotherapy and rehabilitation, surgical treatment.
Read more
Physiotherapy programs applied to patients with Parkinson's disease include classical physiotherapy methods and neurophysiological based methods.
Spinal stabilization is an important concept for proper control of body balance and extremity movements. Spinal stabilization training was based on biomechanics, neurophysiology and physiotherapy research. Stabilization exercises, which form the basis of spinal stabilization training, increase the strength and endurance of the postural and stabilizing muscles using the basic principles of motor learning and improve stability control in stable and unstable positions, provides postural smoothness.
The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors.
Although studies have been carried out to investigate the effect of spinal stabilization exercises in Parkinson's patients, there is no study on the effect of cervical region stabilization exercises in the literature despite these important connections of the cervical region.
For these reasons, this study is planned to investigate the effects of cervical spinal stabilization exercises on spinal posture, cervical proprioception and postural instability in Parkinson's patients.
Hypothesis 1: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, it will be more effective in correcting spinal posture.
Hypothesis 2: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, cervical proprioception will develop better.
Hypothesis 3: In the case of Parkinson's patients, when the cervical spinal stabilization exercises are added to the traditional physiotherapy program, postural stability may be more pronounced.
- Conditions
- Parkinson Disease
- Being tested
- cervical spinal stabilization exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical spinal stabilization exerciseOther
The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| working group | Experimental | Not described Receives: Other: cervical spinal stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Posturography
balance measurement (Number of Participants estimated 20 individuals)
Measured: baseline to 8 week after
X-Ray Measure
scoliosis graphy
Measured: baseline to 8 week after
Bubble Inclinometer
measurement of spine curvature angle (Number of Participants estimated 20 individuals)
Measured: baseline to 8 week after
Scoliometer
measurement of spine curvature angle
Measured: baseline to 8 week after
UPDRS
Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.
Measured: baseline to 8 week after
Berg Balance Scale
balance measurement. It is a 14-item balance scale. The range of points is between 0 and 56. The total score is calculated by summing the points of each item. high score good balance, low score indicates bad balance.
Measured: baseline to 8 week after
Posture Analyse
is a scale that evaluates the participant's 13 different regions from posterior and lateral to postural disorder. the scoring of each region is 1-3-5. if normal is 5 points, moderate level is 3 points, if there is any advanced disorder 1 point is given. the total score is determined by summing all the values. total maximum 65, minimum 13 points. high score good posture, low score indicates bad posture
Measured: baseline to 8 week after
Cervical Proprioception
A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device
Measured: baseline to 8 week after
Visual Analog Scale
Visual Analog Scala. Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. the participant is asked to say a value in this range according to the severity of pain.
Measured: baseline to 8 week after
10 meter walk test
walking speed calculation
Measured: baseline to 8 week after
Timed Get up and Walk Test
walking time and cadence calculation
Measured: baseline to 8 week after
Cervical Ventral Endurance Evaluation
Endurance evaluation will be done to deep cervical flexor extensor muscles
Measured: baseline to 8 week after
Muscle Strength Assessment
evaluation of the strength of the muscles in the cervical region and shoulder circumference
Measured: baseline to 8 week after
Evaluation of Muscle Shortness
measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure
Measured: baseline to 8 week after
Normal Joint Movement Assessment
measurement of normal range of motion
Measured: baseline to 8 week after
Short Form-36
SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.
Measured: baseline to 8 week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start4 Mar 2019
- Primary completion26 Jul 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- BElibol, NKöse, GYÇakmaklı, SAksoy, RGöçmen
- Responsible party
- Principal investigator, Emine Nur Demircan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854747
- Sponsor's protocol ID
- Parkinson's disease treatment
- Status last verified
- Oct 2021
- First submitted
- 16 Feb 2019
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Bronfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4.
PubMed 22895940Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PubMed 18344392Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.
PubMed 19711119Shujaat F, Soomro N, Khan M. The effectiveness of Kayaking exercises as compared to general mobility exercises in reducing axial rigidity and improve bed mobility in early to mid stage of Parkinson's disease. Pak J Med Sci. 2014 Sep;30(5):1094-8. doi: 10.12669/pjms.305.5231.
PubMed 25225533Carter JM, Beam WC, McMahan SG, Barr ML, Brown LE. The effects of stability ball training on spinal stability in sedentary individuals. J Strength Cond Res. 2006 May;20(2):429-35. doi: 10.1519/R-18125.1.
PubMed 16686575Kaya DO, Ergun N, Hayran M. Effects of different segmental spinal stabilization exercise protocols on postural stability in asymptomatic subjects: randomized controlled trial. J Back Musculoskelet Rehabil. 2012;25(2):109-16. doi: 10.3233/BMR-2012-0318.
PubMed 22684202Demircan EN, Kose N, Cakmakli GY, Aksoy S, Gocmen R, Zengin HY, Elibol B. Do cervical stabilization exercises change the effects of conventional exercises in patients with Parkinson's disease? Neurol Res. 2023 Oct;45(10):936-946. doi: 10.1080/01616412.2023.2249699. Epub 2023 Aug 22.
PubMed 37608568
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Cervical Spinal Stabilization Exercises on Spinal Posture, Cervical Proprioception and Postural Instability in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03854747
- Acronym / sponsor ID
- Parkinson's disease treatment
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- BElibol, NKöse, GYÇakmaklı, SAksoy, RGöçmen
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 26 Feb 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.
Parkinson's disease (PH); it occurs due to dopamine deficiency due to the loss of dopaminergic neurons in a degenerative process in the substantia nigra found in the middle brain; resting tremor, bradykinesia, trunk and extremities rigidity, mask facial and postural instability characterized by a neurodegenerative disease. These findings are basic and also motor symptoms of Parkinson's Disease. Non-motor symptoms include many problems ranging from autonomic dysfunction to sensory symptoms.
Treatment of Parkinson's disease requires a multidisciplinary approach such as medical treatment, physiotherapy and rehabilitation, surgical treatment.
Physiotherapy programs applied to patients with Parkinson's disease include classical physiotherapy methods and neurophysiological based methods.
Spinal stabilization is an important concept for proper control of body balance and extremity movements. Spinal stabilization training was based on biomechanics, neurophysiology and physiotherapy research. Stabilization exercises, which form the basis of spinal stabilization training, increase the strength and endurance of the postural and stabilizing muscles using the basic principles of motor learning and improve stability control in stable and unstable positions, provides postural smoothness.
The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors.
Although studies have been carried out to investigate the effect of spinal stabilization exercises in Parkinson's patients, there is no study on the effect of cervical region stabilization exercises in the literature despite these important connections of the cervical region.
For these reasons, this study is planned to investigate the effects of cervical spinal stabilization exercises on spinal posture, cervical proprioception and postural instability in Parkinson's patients.
Hypothesis 1: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, it will be more effective in correcting spinal posture.
Hypothesis 2: When cervical spinal stabilization exercises are added to the traditional physiotherapy program in Parkinson's patients, cervical proprioception will develop better.
Hypothesis 3: In the case of Parkinson's patients, when the cervical spinal stabilization exercises are added to the traditional physiotherapy program, postural stability may be more pronounced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| working group | Experimental | Other: cervical spinal stabilization exercise |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of idiopathic Parkinson's disease,
- Having planned a traditional physiotherapy program for Parkinson's disease and referring to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department,
- 40 to 80 years old,
- According to Hoehn-Yahr scale to be in stage 2 or 3,
- Having scored 30 points above the posture evaluation
Key exclusion criteria (1 listed)
- Volunteers who do not comply with the inclusion criteria 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 |
|---|---|---|
| cervical spinal stabilization exerciseThe cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems. | Other | working group |
Primary outcome
Static Posturography
Time frame: baseline to 8 week after
balance measurement (Number of Participants estimated 20 individuals)
X-Ray Measure
Time frame: baseline to 8 week after
scoliosis graphy
Bubble Inclinometer
Time frame: baseline to 8 week after
measurement of spine curvature angle (Number of Participants estimated 20 individuals)
Scoliometer
Time frame: baseline to 8 week after
measurement of spine curvature angle
UPDRS
Time frame: baseline to 8 week after
Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.
Berg Balance Scale
Time frame: baseline to 8 week after
balance measurement. It is a 14-item balance scale. The range of points is between 0 and 56. The total score is calculated by summing the points of each item. high score good balance, low score indicates bad balance.
Posture Analyse
Time frame: baseline to 8 week after
is a scale that evaluates the participant's 13 different regions from posterior and lateral to postural disorder. the scoring of each region is 1-3-5. if normal is 5 points, moderate level is 3 points, if there is any advanced disorder 1 point is given. the total score is determined by summing all the values. total maximum 65, minimum 13 points. high score good posture, low score indicates bad posture
Cervical Proprioception
Time frame: baseline to 8 week after
A tool used to evaluate the sense of proprioception in the cervical region of the participants with the Cervical Range of Measure(CROM) device
Visual Analog Scale
Time frame: baseline to 8 week after
Visual Analog Scala. Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. the participant is asked to say a value in this range according to the severity of pain.
10 meter walk test
Time frame: baseline to 8 week after
walking speed calculation
Timed Get up and Walk Test
Time frame: baseline to 8 week after
walking time and cadence calculation
Cervical Ventral Endurance Evaluation
Time frame: baseline to 8 week after
Endurance evaluation will be done to deep cervical flexor extensor muscles
Muscle Strength Assessment
Time frame: baseline to 8 week after
evaluation of the strength of the muscles in the cervical region and shoulder circumference
Evaluation of Muscle Shortness
Time frame: baseline to 8 week after
measurement of shortness of some muscles in upper extremity and lower extremity with goniometer and tape measure
Normal Joint Movement Assessment
Time frame: baseline to 8 week after
measurement of normal range of motion
Short Form-36
Time frame: baseline to 8 week after
SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 22895940Kay TM, Gross A, Goldsmith CH, Rutherford S, Voth S, Hoving JL, Bronfort G, Santaguida PL. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD004250. doi: 10.1002/14651858.CD004250.pub4.
- Background: PubMed 18344392Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- Background: PubMed 19711119Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.
- Background: PubMed 25225533Shujaat F, Soomro N, Khan M. The effectiveness of Kayaking exercises as compared to general mobility exercises in reducing axial rigidity and improve bed mobility in early to mid stage of Parkinson's disease. Pak J Med Sci. 2014 Sep;30(5):1094-8. doi: 10.12669/pjms.305.5231.
- Background: PubMed 16686575Carter JM, Beam WC, McMahan SG, Barr ML, Brown LE. The effects of stability ball training on spinal stability in sedentary individuals. J Strength Cond Res. 2006 May;20(2):429-35. doi: 10.1519/R-18125.1.
- Background: PubMed 22684202Kaya DO, Ergun N, Hayran M. Effects of different segmental spinal stabilization exercise protocols on postural stability in asymptomatic subjects: randomized controlled trial. J Back Musculoskelet Rehabil. 2012;25(2):109-16. doi: 10.3233/BMR-2012-0318.
- Derived from this study: PubMed 37608568Demircan EN, Kose N, Cakmakli GY, Aksoy S, Gocmen R, Zengin HY, Elibol B. Do cervical stabilization exercises change the effects of conventional exercises in patients with Parkinson's disease? Neurol Res. 2023 Oct;45(10):936-946. doi: 10.1080/01616412.2023.2249699. Epub 2023 Aug 22.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical spinal stabilization exercise in people with Parkinson Disease, 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 10 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: finished, as of the sponsor's last update on 26 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Posturography (time frame: baseline to 8 week after). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854747, which also lists 7 linked publications.
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 26 Oct 2021.