Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke

NCT02416791 | Terminated Results DMC

• 1 other identifier: 513.207
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.

Conditions

Stroke

Keywords

robotic therapy; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (2)

• Change in Upper Extremity Fugl Meyer Assessment

  Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.

  6 weeks from baseline

• Percentage of Sessions With Adverse Events

  Post treatment (6 weeks from baseline).

Secondary Outcomes (9)

• Change in Modified Rankin Scale

  6 weeks from baseline

• Change in National Institutes of Health Stroke Scale

  6 weeks from baseline

• Change in Stroke Impact Scale

  6 weeks from baseline

• Number of Participants Who Presented Score on Modified Ashworth Scale >2

  6 weeks

• Change in Motor Activity Log

  6 weeks from baseline

Study Arms (3)

Active tDCS + robotic therapy + physical therapy

ACTIVE COMPARATOR

Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).

Device: Robotic Therapy; Device: Active tDCS; Other: Physical Therapy

sham tDCS + robotic therapy + physical therapy

ACTIVE COMPARATOR

Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks).

Device: Robotic Therapy; Device: Sham tDCS; Other: Physical Therapy

sham tDCS + physical therapy + occupational therapy

EXPERIMENTAL

Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).

Device: Sham tDCS; Other: Physical Therapy; Other: Occupational Therapy

Interventions

Robotic Therapy DEVICE

Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.

Active tDCS + robotic therapy + physical therapy; sham tDCS + robotic therapy + physical therapy

Active tDCS DEVICE

Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).

Active tDCS + robotic therapy + physical therapy

Sham tDCS DEVICE

In sham tDCS, no current will be delivered through the tDCS device.

sham tDCS + physical therapy + occupational therapy; sham tDCS + robotic therapy + physical therapy

Physical Therapy OTHER

Physical therapy will be administered for 40 minutes.

Active tDCS + robotic therapy + physical therapy; sham tDCS + physical therapy + occupational therapy; sham tDCS + robotic therapy + physical therapy

Occupational Therapy OTHER

Occupational therapy will be administered for 40 minutes.

sham tDCS + physical therapy + occupational therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
• Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
• Ability to provide written informed consent (patient ou legal representative)
• Ability to comply with the schedule of interventions and evaluations in the protocol.

You may not qualify if:

• Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of \> 3 on the Modified Ashworth Spasticity Scale.
• Upper limb plegia
• Uncontrolled medical problems such as end-stage cancer or renal disease
• Pregnancy
• Seizures, except for a single seizure during the first week post stroke
• Pacemakers
• Other neurological disorders such as Parkinson's disease
• Psychiatric illness including severe depression
• Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
• Hemineglect
• Drugs that interfere on cortical excitability, except for antidepressants
• Cerebellar lesions

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital das Clínicas

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (1)

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Limitations and Caveats

The study was stopped earlier due to low recruitment rates. We consider psychosocial aspects and poor family support as an important factor to these low rates. The small sample size (9 patients) does not allow conclusions with statistical relevance.

Results Point of Contact

• Title: Professor Adriana Bastos Conforto
• Organization: Neurostimulation Laboratory, Hospital das Clínicas/São Paulo University, Brazil

adriana.conforto@hc.fm.usp.br

+55 11 2661-7955

Study Officials

• Adriana B Conforto, MD Phd

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: April 15, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2015-12

Locations

BR (1)