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Evaluation of the Effect of Personalized Exercise Program on Clinical Findings and Quality of Life of Patients With Cervical Dystonia Who Received Botulinum Toxin Type A Injection
Sponsor study identifier
interventional
34
1 country
1
Study Start
October 1, 2022
Actual (reported)Primary Completion
September 17, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Dystonia is involuntary movements characterized by posture abnormalities or repetitive movements as a result of continuous or intermittent simultaneous contraction of opposing muscle groups. Dystonic movements are twisted and twisted in a certain pattern. Dystonia is named in different ways according to its distribution in the body. Cervical dystonia is the most common form of regional dystonia and can be defined as involuntary movements of the head in normal upright posture.Cervical dystonia has different names according to the posture of the neck (torticollis, laterocollis, anterocollis and retrocollis). These different postures can be seen individually as well as together.Pain in cervical dystonia is seen in approximately 70% of patients, and this condition is closely related to involuntary contractions of neck muscles and neck posture disorder. Fatigue, anxiety, unhappiness, decreased self-efficacy and limitation in daily living activities due to decreased neck movements are the main causes of disability in patients with cervical dystonia. The first-line treatment of cervical dystonia consists of injecting botulinum toxin type A into the relevant muscles to alleviate these complaints.There is increasing evidence that range of motion, stretching, and relaxation exercises, in addition to botulinum toxin therapy, have beneficial effects on pain and disability in patients with cervical dystonia.In this study, patients with cervical dystonia who received botulinum toxin type A injection will be divided into study group and control group.The patients in the study group will be given stretching, strengthening, breathing and rhythmic coordination exercises for the muscles involved. (Personalized exercise program) In the control group, only breathing and rhythmic coordination exercises will be given and the two groups will be compared.Thus, it is aimed to investigate the effect of a personalized exercise program on clinical findings and the patient's quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2022
Actual (reported)August 16, 2022
Actual (reported)October 1, 2022
Actual (reported)September 17, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Toronto Western Spasmodic Torticollis Rating Scale Subscale Torticollis Pain Scale (0-20)
A change of at least 5 units from baseline in the torticollis pain scale (0-20), which is a subscale of the Toronto Western Spasmodic Torticollis Rating Scale, after 12 weeks of exercise application. (Higher scores mean a worse outcome.)
0-6-12. Week
Toronto Western Spasmodic Torticollis Rating Scale Subscale Disability Scale(0-30)
0-6-12. Week
Toronto Western Spasmodic Torticollis Rating Scale Subscale Severity Scale (0-35)
0-6-12. Week
Craniocervical dystonia questionnaire (0-100)
0-6-12. Week
The patients in the study group will be given stretching, strengthening, breathing and rhythmic coordination exercises for the muscles involved. (Personalized exercise program)
The patients in the control group will be given only breathing and rhythmic coordination exercises.
The patients in the study group will be given exercise videos. These exercise videos will be selected in accordance with the patient's cervical dystonia type (Torticollis, laterocollis, retrocollis, anterocollis). During the exercises, stretching exercises will be applied to the muscle groups that cause dystonia, and isometric strengthening exercises will be applied to the contralateral muscle groups. Videos including breathing exercises and rhythmic coordination exercises will also be given to all patients in the study and control groups. Patients will be asked to do these exercises for 10 repetitions, three times a day, five days a week. Patients will be asked to mark after each exercise on the exercise chart prepared to determine continuity and compliance with exercise. Patients will be called and followed up on a weekly basis with the exercise chart given to the patients and by telephone.
Ankara University Faculty of Medicine
Ankara, Altındağ, 06230, Turkey (Türkiye)
Boyce MJ, Canning CG, Mahant N, Morris J, Latimer J, Fung VS. Active exercise for individuals with cervical dystonia: a pilot randomized controlled trial. Clin Rehabil. 2013 Mar;27(3):226-35. doi: 10.1177/0269215512456221. Epub 2012 Aug 17.
van den Dool J, Visser B, Koelman JH, Engelbert RH, Tijssen MA. Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial. BMC Neurol. 2013 Jul 15;13:85. doi: 10.1186/1471-2377-13-85.
Sehim Sehim
sehim.kutlay@gmail.com
First Submitted
July 28, 2022
First Posted
August 16, 2022
Study Start
October 1, 2022
Actual (reported)The patients in the study group will be given exercise videos prepared in the Department of Physical Medicine and Rehabilitation of Ankara University Faculty of Medicine. . Videos including breathing exercises and rhythmic coordination exercises will also be given to all patients in the study and control groups. Patients will be asked to do these exercises for 10 repetitions, three times a day, five days a week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.
Turkish Journal of Neurology 2014; 20: Special Issue 1:34-7
Fırat Medical Journal/Firat Med J 2018; 23 (1): 36-38
Ceylan, D. (2018). Evaluation of anxiety and depression, cognitive functions and quality of life among non-motor findings in patients followed up with the diagnosis of cervical dystonia and treated with botulinum toxin and their relatives. Unpublished dissertation. Uludag University Faculty of Medicine.
Johnson AM, Jimenez-Pardo J, Jenkins ME, Holmes JD, Burke SM. Self-reported physical activity among individuals with Parkinson's disease. Sage Open. (2018) 8:215824401877809. doi: 10.1177/2158244018778096
The Effect of Six-Week Physiotherapy and Rehabilitation Program on Balance, Mobility and Quality of Life in a Case with Cervical Dystonia. Fırat Tip Journal 23.1 (2018).
De Pauw J, Van der Velden K, Meirte J, Van Daele U, Truijen S, Cras P, Mercelis R, De Hertogh W. The effectiveness of physiotherapy for cervical dystonia: a systematic literature review. J Neurol. 2014 Oct;261(10):1857-65. doi: 10.1007/s00415-013-7220-8. Epub 2014 Jan 12.
Primary Completion
September 17, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 18, 2025
Record last verified: 2025-09
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