INCOGNITO: Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

Sponsor

Villa Beretta Rehabilitation Center (Other)

Overall Status

Completed

CT.gov ID

NCT03349138

Collaborator

Ecole Polytechnique Fédérale de Lausanne (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Conventional Therapy Device: Robotic Glove Device: Electrical Stimulation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 )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 )

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Therapy 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.	Device: Conventional Therapy
Experimental: Robotic Glove 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.	Device: Robotic Glove
Experimental: Electrical Stimulation 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.	Device: Electrical Stimulation
Experimental: Electrical Stimulation and Robotic Glove 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.	Device: Robotic Glove Device: Electrical Stimulation

Outcome Measures

Primary Outcome Measures

Motricity Index [9 weeks]
Outcome measure to evaluate motor impairment after stroke; subscale for arm only; the subscale ranges from 0 (maximal impairment) to 100 (no impairment).

Secondary Outcome Measures

Action Research Arm Test [baseline; 9 weeks; 13 weeks.]
19-items outcome measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test
Medical Research Council [baseline, 9 weeks, 13 weeks.]
A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5) 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test
Motor Activity Log [baseline; 9 weeks; 13 weeks.]
Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Items scored on a 6-point ordinal scale (0 not used, 6 as good as before).
Box & Blocks Test [baseline; 9 weeks; 13 weeks.]
It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.To administer the test, the examiner is seated opposite the individual in order to observe test performance. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Both arms are tested.
Modified Ashworth Scale [baseline; 9 weeks; 13 weeks]
It measures spasticity. It consists of a test resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-5; a score of 0 indicates no resistance, 5 indicates rigidity. Target muscles: Wrist flexor and extensor, fingers and thumb flexor and extensor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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