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Completed

NCT Number: NCT01828398

tDCS and Robotic Therapy in Stroke

After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Upper Extremity Impairments Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ferrara University Hospital

Ferrara, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females subjects. Age > 18 years.
  • Diagnosis of first ischemic stroke
  • Impairment of the upper limb
  • Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.

Exclusion criteria

  • anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
  • Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
  • contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
  • Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
  • Neurological or psychiatric pathology
  • severe cardio-pulmonary, renal, hepatic diseases
  • Pregnancy

Treatment and study plan

real-tDCS + UE robot-assisted therapy

Device

sham-tDCS + UE robot-assisted therapy

Device

Primary outcomes

  1. Fugl-Meyer Upper Extremity

    Time frame: A week prior to treatment beginning

    Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary outcomes

  1. Box and Block Test

    Time frame: A week prior to treatment beginning

    Test for gross motor function. It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 minute.

  2. Ashworth Modified Scale

    Time frame: A week prior to treatment beginning

    a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist

  3. Motor Activity Log (MAL)

    Time frame: A week prior to treatment beginning

    Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.

  4. Assessment of cortical excitability (TMS)

    Time frame: A week prior to treatment beginning

    MEP of upper limb muscles (first dorsal interosseous) will be recorded with surface EMG electrodes. neurophysiological parameters analyzed:

    • motor threshold at rest
    • MEP recruitment curve at rest
    • MEP amplitude

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2013
Registry last updated
Jan 16, 2014

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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