Kiel University
Kiel, Schleswig-Holstein, 24105, Germany
Location status: Recruiting
NCT Number: NCT04611009
Writer's cramp is the most common task-specific dystonia. It is characterized by involuntary co-contraction of antagonistic muscles during writing. This disabling condition may force patients to give up their occupation. In this study the efficacy of a twelve months long-term training in patients with writer's cramp will be investigated. Two different programs will be offered: The first one will consist of a sensorimotor, the second one of an awareness training. All patients will benefit from video-based supervision with the aim to establish a practice-oriented therapeutic approach that will be available to all patients independently of their home location. The treatment effect will be measured primary with the patient-centered Canadian Occupational Performance Measure (COPM) and secondary with clinical scales to assess the clinical efficacy and everyday constraints. Writing will be assessed with a computer-based kinematic writing analysis. To evaluate the influence on the brain network, several functional magnetic resonance imaging (fMRI) evaluations will be performed. This project is of minimal risk without negative side effects from the training. The risks for the MRI experiment are equal to a non-contrast standard MRI investigation.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Kiel, Schleswig-Holstein, 24105, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for MRI:
In the sensorimotor training program task-specific and non-task specific aspects will be combined. It will start with assignments to improve general finger and wrist movements. After four weeks more specific writing exercises will be added.
The awareness training will contain mindfulness exercises. The goal is to consciously experience the here and now in sensual perception of oneself and the environment.
Time frame: Change from baseline to month 4, 8, 12
The Canadian Occupational Performance Measure will serve as the primary outcome measure. Patients grade their self-perceived performance and satisfaction of writing related occupations in daily life in respect to the goals they had identified and prioritized. The COPM ist patient centered end reflects the real life of the participants.
Time frame: Change from baseline to month 4, 8, 12
The kinematic handwriting analysis will be performed on a pressure sensitive digitizing tablet, that is connected to a laptop to measure movements of the pencil during writing. Regularity of writing will be calculated from this data. All subjects will write a standardized sentence and draw superimposed circles to characterize handwriting movements.
Time frame: Change from baseline to month 4, 8, 12
The video based Writer's Cramp Rating Scale will serve as a secondary outcome parameter. The videos are rated by a blinded movement disorder specialist according to flexion / extension of arm / wrist / fingers during writing.
Time frame: Change from baseline to month 4, 8, 12
During this task participants will be instructed to a) write a sentence using an MR-compatible tablet and b) imagine writing in randomized order. The task is performed during a fMRI measurement. With the imaginary task artefacts are avoided and activation during movement planning will be investigated in the fMRI.
Time frame: Change from baseline to month 4, 12
The purpose of the semi-structured qualitative interviews about the training procedures is to optimize the training and to differentiate between responders and non-responders. The interviews will be will be transcribed word-for-word and analyzed using the qualitative content analysis.
Time frame: Change from baseline to month 4, 8, 12
The Arm Dystonia Disability Scale will be applied to assess how dystonia interferes with manual activities during daily life (writing, buttoning, hygiene, eating, job or household).
Time frame: Change from baseline to month 4, 8, 12
The Serial Reaction Time Task is a standardized method to investigate motor sequence learning and to induce cerebellar activation. We expect that abnormal cerebellar activity in patients compared to controls normalizes after training.
Contact information is provided by the study sponsor or research team.
Arne Knutzen, M.Sc. OT
CONTACT
0431-500-23801 ext. 0049
Kirsten E Zeuner, Prof. MD
CONTACT
0431-500-23801 ext. 0049
University Hospital Schleswig-Holstein
Other
Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03042962
Basal Ganglia Diseases, Blepharospasm Oromandibular Dystonia
Boston, Massachusetts, United States
View Trial DetailsNCT02504905
Central Nervous System Diseases, Cervical Dystonia
Bethesda, Maryland, United States
View Trial DetailsNCT03797638
Central Nervous System Diseases, Dystonic Disorder
Paris, France
View Trial DetailsNCT06554288
Brain Damage, Chronic, Brain Diseases
Kansas City, Missouri, United States
View Trial Details