Clinical trial NCT03349138: Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions
Official title: Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
functional electrical stimulation
electrode array
upper limb
chronic
motor relearning
Lead sponsor: Villa Beretta Rehabilitation Center
Sponsor class: OTHER
Collaborators: name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2017-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conventional treatment allocated to patients in all arms. Supplemental dose matched treatment to each of the four arms (9 weeks, 3 treatments a week) as follows:

* conventional treatment (27 treatments)
* functional electrical stimulation (27 treatments)
* robotic glove ( 27 treatments )
* robotic glove and electrical stimulation ( each session uses one device, half of the sessions uses the robotic glove, half the functional electrical stimulation )
Primary purpose: TREATMENT

Brief summary: This study evaulates the addition to the standard theraphy of enriched sensorimotor training by means of robotic glove therapy, or functional electrical stimulation in the treatment of chronic stroke patients with upper limb motor impairments. All the patients receive the conventional physiotherapic treatment. Supplemental to the conventional treatment, patients are evenly split in four groups to provide different treatments for an equivalent amount of time. Patient in the first group receive supplemental conventional therapy; patients in the second group receive robotic glove therapy; patients in the third group receive functional electrical stimulation; patients in the fourth group receive robotic glove treatment and functional electrical stimulation in different sessions.

Detailed description: Stroke very frequently impacts on patients' motor function, and particularly on upper limb movements. Limited hand functionality is a major negative outcome after stroke, negatively affecting patients' recovery and independence, with major impact on rehabilitation.However, standard motor rehabilitation outcome is often suboptimal, because insufficient or non-specific treatment is provided. Robotic hand mobilization and functiona electrical stimulation grasp rehabilitation each improve motor capabilities in grasp impaired patients, but they do so by different mechanisms.

Robotic hand mobilization achieves grasp rehabilitation by providing passive mobilization of the affected limb if the subject does not react to the designed task.

Functional electrical stimulation achieves grasp rehabilitation by inducing localized muscle contraction, that is by providing an electrical field able to stimulate both sensory afferent pathways and lower motor neurons in the targeted volume.

Eligibility criteria: Inclusion Criteria:

* Adults male and/or female, older than 18 years
* Patients who have suffered one or more strokes with major unilateral functional impairment
* Hemiplegic, left and right unilateral lesion
* Chronic phase of stroke at least six months before study enrollment
* Level of impairment: hand and/or arm
* No left handed
* Mini-Mental State Examination \> 20

Exclusion Criteria:

* Limitation for using the device due to impairment of Passive Range of Motion and/or
* Pain due to Spasticity evaluated using Modified Ashworth Scale (\>=3)
* Previous history of major neurological or psychiatric disorders
* allergy to electrodes

Primary outcomes:
measure: Motricity Index
timeFrame: 9 weeks
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: baseline; 9 weeks; 13 weeks.
measure: Medical Research Council
timeFrame: baseline, 9 weeks, 13 weeks.
measure: Motor Activity Log
timeFrame: baseline; 9 weeks; 13 weeks.
measure: Box & Blocks Test
timeFrame: baseline; 9 weeks; 13 weeks.
measure: Modified Ashworth Scale
timeFrame: baseline; 9 weeks; 13 weeks
Other outcomes:
Locations:
city: Costa Masnaga
country: Italy
facility: Villa Beretta Rehabilitation Center
state: Lecco
Study officials:
affiliation: Villa Beretta Rehabilitation Center
name: Franco Molteni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.