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Video-supervised Motor and Awareness Training in Writer's Cramp

Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04611009
Enrollment
54
Registered
2020-11-02
Start date
2020-06-26
Completion date
2027-01-01
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Writer's Cramp

Keywords

dystonia, training, kinematic writing analysis, COPM, functional magnetic resonance imaging

Brief summary

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.

Interventions

BEHAVIORALmotor training

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.

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants are blinded towards their participation in the two arms Clinical scales, kinematic writing anlysis and functional MRI will be analyzed by persons, who are blinded to the type of training group allocation

Intervention model description

randomized, controlled, double blinded trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Right handed idiopathic WC according to standardized criteria (simple and complex WC, any dystonic posture (including flexion, extension, pronation, supination)) * able to participate in video-calls

Exclusion criteria

* Additional neurological or psychiatric diseases * left-handed patients * last botulinum toxin treatment \<3 months, remaining weakness from the last injection * concomitant use of anticholinergics or sedating medication

Design outcomes

Primary

MeasureTime frameDescription
Canadian Occupational Performance MeasureChange from baseline to month 4, 8, 12The 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.

Secondary

MeasureTime frameDescription
Writer's Cramp Rating ScaleChange from baseline to month 4, 8, 12The 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.
writing during functional magnetic resonance imaging (fMRI)Change from baseline to month 4, 8, 12During 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.
kinematic writing analysisChange from baseline to month 4, 8, 12The 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.
Arm Dystonia Disability ScaleChange from baseline to month 4, 8, 12The 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).
Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)Change from baseline to month 4, 8, 12The 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.
qualitative interviewsChange from baseline to month 4, 12The 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.

Countries

Germany

Contacts

Primary ContactKirsten E Zeuner, Prof. MD
k.zeuner@neurologie.uni-kiel.de0431-500-23801
Backup ContactArne Knutzen, M.Sc. OT
a.knutzen@neurologie.uni-kiel.de0431-500-23801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026