Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lowe… (NCT04780191) | Clinical Trial Compass
CompletedNot Applicable
Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke
France44 participantsStarted 2018-07-19
Plain-language summary
This is a single center, randomized, double-blind (patient and evaluator), sham-controlled study. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active versus sham treated stroke patients with lower-limb spasticity after 5 consecutive days of treatment.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, e…
What they're measuring
1
Change in spasticity from baseline to after the last treatment session
Timeframe: Immediately after last treatment session