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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Electrical Stimulation; Device: Conventional Therapy; Device: Robotic Glove

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lecco
    • Costa Masnaga, Lecco, Italy, 23845
      • Villa Beretta Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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: Electrical Stimulation; Device: Robotic Glove

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	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	baseline; 9 weeks; 13 weeks.
Medical Research Council	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	baseline, 9 weeks, 13 weeks.
Motor Activity Log	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).	baseline; 9 weeks; 13 weeks.
Box & Blocks Test	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.	baseline; 9 weeks; 13 weeks.
Modified Ashworth Scale	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	baseline; 9 weeks; 13 weeks

Collaborators and Investigators

• Sponsor: Villa Beretta Rehabilitation Center
• Collaborators: Ecole Polytechnique Fédérale de Lausanne

Publications and helpful links

General Publications

• 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 (N Y). 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): August 31, 2017

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (ACTUAL): November 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: functional electrical stimulation; rehabilitation; upper limb; chronic; electrode array; motor relearning
• Other Study ID Numbers: INCOGNITO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No