New device aims to loosen stiff legs in stroke survivors
NCT ID NCT04780191
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device called MyoRegulator® to see if it can reduce muscle stiffness (spasticity) in the lower leg after a stroke. 44 adults who had a stroke at least 6 months earlier took part. Half received real treatment and half received a sham (fake) treatment for 5 days, and researchers measured changes in stiffness and walking ability.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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44 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Jan 2021
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Stroke, with cortical and/or subcortical lesions, of at least 6-months duration at study inclusion * Spasticity in the lower extremity plantarflexors (gastrocnemius, soleus muscles) due to stroke with a baseline score of 1-4 as assessed by the Tardieu scale * Minimum 1-month duration of spasticity as confirmed by medical history * Modified Rankin score \< 4 * Cognitive functions sufficient to understand the experiments and follow instructions and ability to provide informed consent in accordance with ICH and GCP * Affiliated with the French social security scheme, universal medical coverages (CMU), or an equivalent scheme. Exclusion Criteria: * Enrollment in another biomedical research study at the time of the MyoRegulator study. * Fixed contractures or profound muscle atrophy in the spastic limb * Ongoing use of digitalis, morphine, intrathecal pump * Plantar orthosis or history of orthopedic surgery that can interfere with gait analysis * Botulinum toxin treatment within 12 weeks of study enrollment * Prior phenol or alcohol injections within 6 months of study enrollment * Change in the antispastic treatment (baclofen, clonidine, benzodiazepine, dantrolene, gabapentine, tizanidin) in the 2 months prior to visit 1. * Allergy to latex * Presence of potential tsDCS risk factors: * Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, cancerous lesions, etc.) * Lack of sensory perception at the stimulation sites * Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker, epidural stimulation electrodes, etc.), an intravascular clip or any other electrically sensitive support system * Metal in or on the body in the direct path of the stimulation current (jewelry must be removed during stimulation) * Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months * Prior trans-spinal direct current stimulation for any reason or prior trans-cranial direct current stimulation in the past 12 months * Any medical condition that would prevent the subject from being able to participate in the clinical outcome measures * Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women), or lactating women or women planning pregnancy during the course of the study * Patient under guardianship or curatorship, or under judicial supervision
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre d'investigation clinique, Institut du Cerveau et de la Moelle
Paris, 75013, France
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Other studies related to the condition(s) this trial covers.
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