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Completed

NCT Number: NCT02496026

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auxilium Vitae Rehabilitation Centre

Volterra, 56048, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

tDCS plus wrist robot therapy

Device

Patients receive robotic rehabilitation session while tDCS stimulator is switched on

Sham tDCS plus wrist robot therapy

Device

Patients receive robotic rehabilitation session while tDCS stimulator is switched off.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Auxilium Vitae Volterra

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2015
Registry last updated
Aug 13, 2020

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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