The Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis
NCT ID: NCT03743740
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2018-12-03
2019-04-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study was to investigate the effects of spinal stabilization exercises on fatigue, muscle strength, pulmonary functions and functional capacity in patients with MG.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises in Patients With Myasthenia Gravis
NCT06158815
The Effect of Combined Exercise and NMES on Strength, Proprioception and Reaction Time in Scapholunate Instability
NCT06627296
Integrating Art Therapy and Adapted Physical Activity: Toward Improved Quality of Life in Patients With Myasthenia Gravis
NCT07125105
Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises
NCT05885282
Effects of Core Stabilization Approach on Patients With Upper Extremity Injuries
NCT01659112
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The weakness of the limb muscles is proximal and distal in the arms and more proximal muscles in the legs. As the disease progresses, weakness occurs in most striated muscles. This causes weakness in the trunk muscles.
In the literature, the physiotherapy methods used in MG patients include breathing exercises, aerobic exercises and resistant exercises.Spinal stabilization exercises enable activation of the trunk muscles.
Spinal stabilization exercises, which use the basic principles of motor learning, aiming to improve the coordination, contraction rate and endurance of the body muscles by increasing kinesthetic awareness, can be used to strengthen body stability. Spinal stabilization exercises are a type of exercise that aims more smooth limb movements with a strong spine, ensuring smoothness and stability of the spine. In the literature, there is no study using spinal stabilization exercises in MG patients. The aim of this study was to investigate the effects of spinal stabilization exercises on fatigue, muscle strength, pulmonary functions and functional capacity in patients with MG.
Method The study was planned as randomized, single-blind and cross-over. Randomization will be done with closed envelope system. Group 1 will be written on five sheets and group 2 will be written on another five sheets.
Then, these papers will be placed on the envelopes, these envelopes will be mixed in a box and patients will be asked to withdraw from these envelopes.
Thus, patients will be divided into 2 groups. Assessments will be made by Yeliz Salcı and Ebru Kütük Çalıkçı. The assessors will not know who is in the which group. Treatment intervention will be done by Ali Naim Ceren. The assessors will evaluate patients without knowing the patients' groups. So the work will be single blind. Group 1, 3 days per week for 6 weeks so that it will be taken to the physiotherapy program consisting of spinal stabilization exercises. Also the treatment will be supported by home program exercises. The patients will be rested for 4 weeks to eliminate the effects of the spinal stabilization program. After this period, only the home program will be given for 6 weeks. In Group 2; treatment will start with a 6-week home program, followed by a 4-week break.
At the end of this period to be 3 days a week for 6 weeks spinal stabilization exercise program will be implemented. In addition to this exercise program, patients will be given a home program. The home program will include breathing exercises tailored to the patient's needs, calisthenic exercises, and MAT activities.
Assessments will be made at the beginning of the treatment, after 6 weeks of treatment, at the end of 4 weeks of rest and at the end of 6 weeks of treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
first, patients will undergo spinal stabilization exercise and home based program 3 days per week for 6 weeks.
then, exercises will be suspended for 4 weeks. then, patients will undergo home based program 3 days per week for 6 weeks.
Spinal stabilization exercise
The effects of spinal stabilization exercise in patients with myasthenia gravis will be investigated.There is no study in the literature that previously applied spinal stabilization exercises in patients with myasthenia gravis. The benefits of spinal stabilization exercises in other diseases are shown.
Group 2
first, patients will undergo home based program 3 days per week for 6 weeks. then, exercises will be suspended for 4 weeks. then, patients will undergo spinal stabilization exercise and home based program 3 days per week for 6 weeks.
Spinal stabilization exercise
The effects of spinal stabilization exercise in patients with myasthenia gravis will be investigated.There is no study in the literature that previously applied spinal stabilization exercises in patients with myasthenia gravis. The benefits of spinal stabilization exercises in other diseases are shown.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spinal stabilization exercise
The effects of spinal stabilization exercise in patients with myasthenia gravis will be investigated.There is no study in the literature that previously applied spinal stabilization exercises in patients with myasthenia gravis. The benefits of spinal stabilization exercises in other diseases are shown.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged between18-65 years,
* To be in Stage II or III according to the Clinical Classification of the Medialia Gravis Functional Assessment (MGFA),
* The Mini Mental Test score should be over 24 in order to be cooperative to the physiotherapist's instructions,
* To volunteer to participate in the study.
Exclusion Criteria
* To have had myasthenic crisis in the last month,
* Modification of medical treatment and dose in the last month,
* Systemic, orthopedic and neurological disease in addition to the disease
* Participation in physiotherapy program in the last six months.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hacettepe University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ali Naim Ceren
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.
Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
Nicolle MW. Myasthenia Gravis and Lambert-Eaton Myasthenic Syndrome. Continuum (Minneap Minn). 2016 Dec;22(6, Muscle and Neuromuscular Junction Disorders):1978-2005. doi: 10.1212/CON.0000000000000415.
Feasson L, Camdessanche JP, El Mandhi L, Calmels P, Millet GY. Fatigue and neuromuscular diseases. Ann Readapt Med Phys. 2006 Jul;49(6):289-300, 375-84. doi: 10.1016/j.annrmp.2006.04.015. Epub 2006 Apr 25. English, French.
Elsheikh B, Arnold WD, Gharibshahi S, Reynolds J, Freimer M, Kissel JT. Correlation of single-breath count test and neck flexor muscle strength with spirometry in myasthenia gravis. Muscle Nerve. 2016 Jan;53(1):134-6. doi: 10.1002/mus.24929.
Salci Y, Karanfil E, Balkan AF, Kutukcu EC, Ceren AN, Ayvat F, Bekircan-Kurt CE, Armutlu K. Functional exercise capacity evaluated by timed walk tests in myasthenia gravis. Muscle Nerve. 2019 Feb;59(2):208-212. doi: 10.1002/mus.26345. Epub 2018 Oct 17.
Yang Y, Zhang M, Guo J, Ma S, Fan L, Wang X, Li C, Guo P, Wang J, Li H, Li Z. Quality of life in 188 patients with myasthenia gravis in China. Int J Neurosci. 2016;126(5):455-62. doi: 10.3109/00207454.2015.1038712. Epub 2015 Jun 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KA-17132
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.