Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity

NCT ID: NCT02700061

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-02-28

Brief Summary

The purpose of this study is to evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies.

Detailed Description

The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke.

The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy.

Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT.

The investigator and the raters are blind to treatment.

The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment.

The sample size was estimated to be 62 patients in each arm, a total size of 124 patients

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Induced Constraint Therapy - ICT

Physical rehabilitation with Induced Constraint Therapy as part of the occupational therapy. Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.

Group Type: EXPERIMENTAL

Induced Constraint Therapy - ICT

Intervention Type: PROCEDURE

Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.

Robotic occupational therapy

Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks.

Group Type: EXPERIMENTAL

Robotic occupational therapy

Intervention Type: PROCEDURE

Robotic Occupational Therapy three times a week for twelve weeks.

Interventions

Robotic occupational therapy

Robotic Occupational Therapy three times a week for twelve weeks.

Intervention Type: PROCEDURE

Induced Constraint Therapy - ICT

Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.

Intervention Type: PROCEDURE

Other Intervention Names

Robotic therapy; ICT

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of stroke;
• Patients from 6 months after stroke up to 36 months after stroke;
• Clinically stable;
• Upper limb Brunnstrom scale III or IV;
• Brunnstrom scale above V if clinician supports patients will benefit from treatment;
• Minimum wrist extension of 20°, and minimum of 10° of metacarpophalangeal active extension.
• Signed Informed Consent Form;

Exclusion Criteria

• Mini-Mental score lower than 20 points;
• Previous multiple strokes;
• Bone diseases and articulation injuries ;
• Presence of psychological disturbances capable of diminishing adherence;
• Articulation pain within the range of motion proposed by the therapies;
• Participation in another study protocol for upper limbs therapies.
• Previous treatment with robotic assisted therapies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linamara Rizzo Battistella, Md PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Terranova TT, Simis M, Santos ACA, Alfieri FM, Imamura M, Fregni F, Battistella LR. Robot-Assisted Therapy and Constraint-Induced Movement Therapy for Motor Recovery in Stroke: Results From a Randomized Clinical Trial. Front Neurorobot. 2021 Jul 21;15:684019. doi: 10.3389/fnbot.2021.684019. eCollection 2021.

Reference Type: DERIVED

PMID: 34366819 (View on PubMed)

Other Identifiers

0910.0.015.000-11

Identifier Type: -

Identifier Source: org_study_id