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

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Recruiting
CT.gov ID
NCT04611009
Collaborator
(none)
54
1
2
34.1
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: motor training
  • Behavioral: mindfulness exercises
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, controlled, double blinded trialrandomized, controlled, double blinded trial
Masking:
Double (Participant, 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
Primary Purpose:
Treatment
Official Title:
Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp
Actual Study Start Date :
Jun 26, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: motor training

intervention: motor training

Behavioral: motor 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.

Active Comparator: awareness training

intervention: mindfulness exercises

Behavioral: mindfulness exercises
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.

Outcome Measures

Primary Outcome Measures

  1. Canadian Occupational Performance Measure [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.

Secondary Outcome Measures

  1. kinematic writing analysis [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.

  2. Writer's Cramp Rating Scale [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.

  3. writing during functional magnetic resonance imaging (fMRI) [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.

  4. qualitative interviews [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.

  5. Arm Dystonia Disability Scale [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).

  6. Serial Reaction Time Task during functional magnetic resonance imaging (fMRI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Exclusion criteria for MRI:
  • Cardiac pacemaker, electronic or metal implants

  • pregnancy or suspected pregnancy

  • severe ametropia, anxiety in small rooms

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kiel University Kiel Schleswig-Holstein Germany 24105

Sponsors and Collaborators

  • University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Kirsten E Zeuner, Prof. MD, Kiel University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT04611009
Other Study ID Numbers:
  • DE 579/17
First Posted:
Nov 2, 2020
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Schleswig-Holstein
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2020