Exercise Program for Patients With Cervical Dystonia Who Are Treated With Botulinum Toxin Type A

NCT05502718 | Recruiting

• 1 other identifier: I05-279-22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dystonia, Cervical

Keywords

Botulinum Toxin Type A; Exercise; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Study Group

ACTIVE COMPARATOR

The patients in the study group will be given stretching, strengthening, breathing and rhythmic coordination exercises for the muscles involved. (Personalized exercise program)

Other: Stretching and Strengthening Exercises; Other: Breathing and Rhythmic Coordination Exercises

Control Group

PLACEBO COMPARATOR

The patients in the control group will be given only breathing and rhythmic coordination exercises.

Other: Breathing and Rhythmic Coordination Exercises

Interventions

Stretching and Strengthening Exercises OTHER

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.

Study Group

Breathing and Rhythmic Coordination Exercises OTHER

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.

Control Group; Study Group

Eligibility Criteria

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

You may qualify if:

• Be over 18 years old
• Completion of Informed Signed Consent Form
• Diagnosis of cervical dystonia by neurology
• Botulinum toxin injection for cervical dystonia in Ankara University Faculty of Medicine Neurology Department Movement Disorders Outpatient Clinic
• To have the necessary infrastructure to watch the prepared exercise videos on computers, phones, tablets.

You may not qualify if:

• Cardiovascular, systemic or musculoskeletal problems that prevent participation in the exercise program
• Presence of dementia/cognitive disorder or symptomatic psychiatric disease, which was previously diagnosed or detected during the anamnesis process, preventing participation in the program
• Failure to approve the Informed Signed Consent Form

Sponsors & Collaborators

• Prof. Dr. Şehim Kutlay: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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.

  PMID: 22904115 BACKGROUND

• Barnea ER, MacLusky NJ, DeCherney AH, Naftolin F. Monoamine oxidase activity in the term human placenta. Am J Perinatol. 1986 Jul;3(3):219-24. doi: 10.1055/s-2007-999871.

  PMID: 3718643 BACKGROUND

• 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.

  PMID: 29027544 BACKGROUND

• Turkish Journal of Neurology 2014; 20: Special Issue 1:34-7

  BACKGROUND

• Fırat Medical Journal/Firat Med J 2018; 23 (1): 36-38

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 24413637 BACKGROUND

MeSH Terms

Conditions

Torticollis; Motor Activity

Interventions

Respiration

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Sehim Sehim

  sehim.kutlay@gmail.com

  STUDY DIRECTOR

Central Study Contacts

Sehim Kutlay

CONTACT

+905325625906; sehim.kutlay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 16, 2022
• Study Start: October 1, 2022
• Primary Completion: September 17, 2025
• Study Completion: October 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)