Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

August 12, 2020 updated by: federico posteraro, Auxilium Vitae Volterra
The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern.

As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Volterra, Italy, 56048
        • Auxilium Vitae Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. persons affected by first supratentorial stroke, whose onset time is 25±7 days;
  2. upper limb hemiparesis;
  3. cognitive and speech abilities sufficient to understand instructions and to provide informed consent;
  4. absence of intense pain due to passive wrist mobilization assessed by VAS < 3 (range 0-10);
  5. ability to provide written informed consent.

Exclusion Criteria:

  1. previous epilepsy seizures;
  2. severe electroencephalographic anomalies;
  3. previous neurosurgery interventions involving metallic elements placement;
  4. ongoing anticonvulsant drugs treatment
  5. inability to keep sitting posture;
  6. severe sensory deficits;
  7. general clinical complication preventing delivery of rehabilitation treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS plus wrist robot therapy
In addition to standard rehabilitation treatment Group A will perform daily sessions of wrist robot-assisted treatment in combination with tDCS (30 minutes). During first 20 min of each session the patient receives a direct current stimulation through surface sponge electrodes (35 cm2), 2 milliampere intensity: the anodal electrode is placed on presumed lesional area, the cathodal electrode is placed on the controlateral orbital bone.
Device: tDCS plus wrist robot therapy
Patients receive robotic rehabilitation session while tDCS stimulator is switched on
Sham Comparator: Sham tDCS plus wrist robot therapy
Group B is treated as Group A, but tDCS, even if the cap is applied on the patient head, is not activated and no current is delivered.
Device: Sham tDCS plus wrist robot therapy
Patients receive robotic rehabilitation session while tDCS stimulator is switched off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
Time Frame: 6 weeks
Impairment level measure according to ICF
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
Time Frame: 6 months
Impairment level measure according to ICF
6 months
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Time Frame: 6 weeks
Impairment level measure according to ICF
6 weeks
Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index
Time Frame: 6 months
Impairment level measure according to ICF
6 months
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Time Frame: 6 weeks
Impairment level measure according to ICF
6 weeks
Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale
Time Frame: 6 months
Impairment level measure according to ICF
6 months
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Time Frame: 6 weeks
Activities level measure according to ICF
6 weeks
Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test
Time Frame: 6 months
Activities level measure according to ICF
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auxilium Vitae Volterra

Investigators

  • Principal Investigator: Federico Posteraro, MD, Auxilium Vitae Rehabilitation Centre
  • Study Director: Stefano Mazzoleni, PhD, The BioRobotics Institute, Scuola Superiore Sant'Anna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 22, 2017

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN20141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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