Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

Stroke Clinical Trial

— INCOGNITO  

Official title:

Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349138
• Other study ID #: INCOGNITO
• Status: Completed
• Phase: N/A
• First received: November 8, 2017
• Last updated: November 21, 2017
• Start date: January 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2017
• Source: Villa Beretta Rehabilitation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Conventional Therapy

• Robotic Glove

• Electrical Stimulation

Locations

Country	Name	City	State
Italy	Villa Beretta Rehabilitation Center	Costa Masnaga	Lecco

Sponsors (2)

Lead Sponsor	Collaborator
Villa Beretta Rehabilitation Center	Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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