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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: tDCS plus wrist robot therapy; Device: Sham tDCS plus wrist robot therapy

• Registration Number: NCT02496026
• Lead Sponsor: Auxilium Vitae Volterra

Brief Summary

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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-22
• Status Verified: 2019-07
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS plus wrist robot therapy	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.
Sham tDCS plus wrist robot therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Auxilium Vitae Rehabilitation Centre; 🇮🇹 Volterra, Italy