Clinical Trials Logo

Clinical Trial Summary

The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis. The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC). SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.


Clinical Trial Description

After the informed consent process, each centre will screen potential participants according to the inclusion and exclusion criteria. Each recruited participant will be randomly assigned to one group: - experimental group - patients will receive self-modulated functional electrical stimulation SM-FES; - control group - patients will receive standard care SC. This first main phase of the study includes 10 days intervention delivered to the two groups and assessments pre-intervention, post-intervention and after 3 months (follow-up). After the follow-up, participants initially recruited in the control group will be able to enter a secondary exploratory phase and receive further 10 days of treatment with SM-FES. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04014270
Study type Interventional
Source Intento SA
Contact
Status Terminated
Phase N/A
Start date November 8, 2019
Completion date May 22, 2023

See also
  Status Clinical Trial Phase
Completed NCT03031977 - Visceral Mobilization and Functional Constipation in Stroke Survivors N/A
Not yet recruiting NCT04378946 - Error Augmentation Motor Learning Training Approach in Stroke Patients N/A
Completed NCT05690165 - Effects of Aerobic Exercise During the Early Rehabilitation After Ischemic Stroke N/A
Not yet recruiting NCT06053970 - Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting N/A
Completed NCT03023150 - Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert N/A
Not yet recruiting NCT06128187 - The Effect of Dual Task Training on Upper Extremity Functions in Stroke Patients N/A
Completed NCT03773653 - Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique N/A
Recruiting NCT05505201 - Effectiveness of Transcranial Magnetic Stimulation in Subacute Stroke Patients With Severe Upper Limb Paresis N/A
Recruiting NCT05993091 - Mirror Therapy and Augmented Reality in Stroke Rehabilitation N/A
Recruiting NCT04682223 - Telerehabilitation for Aphasia (TERRA) N/A
Completed NCT03165630 - Stroke Patients' Outpatient Rehabilitation Therapy (SPORT) N/A
Recruiting NCT04800601 - Walking Ankle isoKinetic Exercise N/A
Recruiting NCT05944666 - Substantiation and Standardization of the Multimodal Cognitive-motor Rehabilitation System for Afterstroke Patients N/A
Enrolling by invitation NCT05447754 - Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients N/A
Completed NCT03798340 - Vibratory Perturbation-based Pinch Task Training for Stroke Patients N/A
Completed NCT02603718 - An Applicative On-line EEG Tool for Enhancing Treatment Efficacy N/A
Completed NCT05391919 - Multimodal Correction of Post-stroke Motor and Cognitive Impairments N/A
Recruiting NCT05945212 - Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients. N/A
Completed NCT04753931 - Effects of Sensory Training Application in Addition to Bobath Training N/A
Recruiting NCT03866057 - Post Stroke Intensive Rehabilitation