Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions (INCOGNITO)

Villa Beretta Rehabilitation Center

Status: Completed

Conditions: Stroke

Treatments: Device: Robotic Glove; Device: Conventional Therapy; Device: Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03349138

INCOGNITO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Conventional Therapy

Active Comparator group

Description:

27 sessions, 3 sessions per week for a total of 9 weeks. Each session lasts about 90 minutes and consists of different standard motor training modalities typically used in the rehabilitation of the arm after stroke. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Treatment:

Device: Conventional Therapy

Robotic Glove

Experimental group

Description:

Robotic Glove \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the robotic glove system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Treatment:

Device: Robotic Glove

Electrical Stimulation

Experimental group

Description:

Electrical Stimulation \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the electrical stimulation system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Treatment:

Device: Electrical Stimulation

Electrical Stimulation and Robotic Glove

Experimental group

Description:

Electrical Stimulation \& Robotic Glove \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the electrical stimulation system plus 60 minutes of conventional therapy or 30-minute training with the robotic glove system plus 60 minutes of conventional therapy. Half of the sessions are allocated to the electrical stimulation system, and half are allocated to the robotic glove system. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Treatment:

Device: Robotic Glove

Device: Electrical Stimulation