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StrokeINCOGNITONCT03349138

Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

A study testing Conventional Therapy, Robotic Glove and Electrical Stimulation in people with Stroke, run by Villa Beretta Rehabilitation Center at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Conventional Therapy, Robotic Glove and Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
1 Jan 2015to 31 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Villa Beretta Rehabilitation Center

    Costa Masnaga, Lecco, 23845

Other trials in Italy

About this study

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.

Read the 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.

Conditions
Stroke
Being tested
Conventional Therapy, Robotic Glove, Electrical Stimulation
Keywords
rehabilitation, functional electrical stimulation, electrode array, upper limb, chronic, motor relearning
Medical subject headings
Stroke, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03349138
Study groupRoleWhat they receive
Conventional TherapyActive comparator27 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.
Receives: Device: Conventional Therapy
Robotic GloveExperimentalRobotic 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.
Receives: Device: Robotic Glove
Electrical StimulationExperimentalElectrical 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.
Receives: Device: Electrical Stimulation
Electrical Stimulation and Robotic GloveExperimentalElectrical 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.
Receives: Device: Robotic Glove; Device: Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 9 weeks

Secondary outcomes (5)

  1. 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

    Measured: baseline; 9 weeks; 13 weeks.

  2. 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

    Measured: baseline, 9 weeks, 13 weeks.

  3. 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).

    Measured: baseline; 9 weeks; 13 weeks.

  4. 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.

    Measured: baseline; 9 weeks; 13 weeks.

  5. 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

    Measured: baseline; 9 weeks; 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2017
  2. Study start1 Jan 2015
  3. Primary completion1 Jun 2017
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 )
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03349138
Sponsor's protocol ID
INCOGNITO
Acronym
INCOGNITO
Status last verified
Nov 2017
First submitted
8 Nov 2017
Last updated
24 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

    PubMed 35590144

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Therapy, Robotic Glove and Electrical Stimulation in people with Stroke, run by Villa Beretta Rehabilitation Center at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motricity Index (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03349138, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.

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