Dystonic DisordersFIDEXNCT02882334
Finger Individuation Training With a Training Device Versus Conventional Rehabilitation for Writer's Cramp
A study testing Finger Force Manipulandum and Conventional physiotherapy in people with Dystonic Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dystonic Disorders
- What is being tested?
- Finger Force Manipulandum and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders
- handwriting speed < 140 letters per minute
- simple or complex writer's cramp
- scholarship in French language
- absence of treatment by botulinum neurotoxin, or last injection > 3 months
- age > 18 and < 71 years
- informed consent
- medical insurance coverage
Who cannot join
- writer's cramp with no impact on writing
- writing tremor
- other neurological disease with effect on writing
- pain or traumatism of the limb used for writing, requiring medical or surgical treatment in the last preceding months
- participation in another research with a potential impact on evaluation criteria
- pregnant or breast feeding patient
- patient under judiciary protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp
Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients.
- Conditions
- Dystonic Disorders
- Being tested
- Finger Force Manipulandum, Conventional physiotherapy
- Keywords
- Focal Dystonia, Writer's cramp
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger Force ManipulandumDevice
Conventional physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Finger individuation training | Experimental | Finger Force Manipulandum Receives: Device: Finger Force Manipulandum |
| control | Active comparator | conventional physiotherapy Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in writing speed after rehabilitation
number of letters correctly copied in 60 seconds
Measured: Change from baseline writing speed at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start8 Nov 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: Difficultés d'inclure, les patients sont rares
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonic DisordersStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Foundation Jacques and Gloria Gossweiler
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre BLETON, PhD, Study chair, Fondation OPH A de RothschildPavel Lindberg, PhD, Study director, Centre de Psychiatrie et Neurosciences, Inserm U894Sophie SANGLA, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882334
- Sponsor's protocol ID
- SSA_2016_15
- Acronym
- FIDEX
- Status last verified
- Jul 2021
- First submitted
- 24 Aug 2016
- Last updated
- 19 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp
- ClinicalTrials.gov ID
- NCT02882334
- Acronym / sponsor ID
- FIDEX / SSA_2016_15
- Conditions
- Dystonic Disorders
- Keywords
- Focal Dystonia, Writer's cramp
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficultés d'inclure, les patients sont rares
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Foundation Jacques and Gloria Gossweiler
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finger individuation training | Experimental | Device: Finger Force ManipulandumFinger Force Manipulandum |
| control | Active comparator | Other: Conventional physiotherapyconventional physiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders
- handwriting speed < 140 letters per minute
- simple or complex writer's cramp
- scholarship in French language
- absence of treatment by botulinum neurotoxin, or last injection > 3 months
Key exclusion criteria (7 listed)
- writer's cramp with no impact on writing
- writing tremor
- other neurological disease with effect on writing
- pain or traumatism of the limb used for writing, requiring medical or surgical treatment in the last preceding months
- participation in another research with a potential impact on evaluation criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger Force Manipulandum | Device | Finger individuation training |
| Conventional physiotherapy | Other | control |
Primary outcome
change in writing speed after rehabilitation
Time frame: Change from baseline writing speed at week 8
number of letters correctly copied in 60 seconds
Results and safety
The study was stopped early (reason given: Difficultés d'inclure, les patients sont rares). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre BLETON, PhD study chair
Fondation OPH A de Rothschild
Pavel Lindberg, PhD study director
Centre de Psychiatrie et Neurosciences, Inserm U894
Sophie SANGLA, MD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger Force Manipulandum and Conventional physiotherapy in people with Dystonic Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficultés d'inclure, les patients sont rares). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in writing speed after rehabilitation (time frame: Change from baseline writing speed at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.