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NCT Number: NCT03349138

Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

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.

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Key information

Conditions

Stroke Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Organizing Pneumonia Respiratory Tract Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Therapy

Device

Robotic Glove

Device

Electrical Stimulation

Device

Primary outcomes

  1. Motricity Index

    Time frame: 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 outcomes

  1. Action Research Arm Test

    Time frame: 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

  2. Medical Research Council

    Time frame: 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

  3. Motor Activity Log

    Time frame: 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).

  4. Box & Blocks Test

    Time frame: 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.

  5. Modified Ashworth Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Villa Beretta Rehabilitation Center

Other

Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

Registry information

Acronym: INCOGNITO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2017
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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