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

Phase 2

• Conditions: Stroke
• Interventions: Procedure: Induced Constraint Therapy - ICT; Procedure: Robotic occupational therapy

• Registration Number: NCT02700061
• Lead Sponsor: University of Sao Paulo General Hospital

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

Study Timeline

• Study Start: 2012-02
• Status Verified: 2015-08
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2016-03-01
• Last Update Submitted: 2016-03-01
• Study First Posted: 2016-03-07
• Last Update Posted: 2016-03-07
• Primary Completion: 2016-04
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induced Constraint Therapy - ICT	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.
Robotic occupational therapy	Robotic occupational therapy	Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks.

Primary Outcome Measures

Name	Time	Method
Change on Motor Function assessed by Wolf Motor Function scale	Baseline and 12 weeks	Change from baseline in Wolf Motor Function scale.
Change on Motor Function assessed by Fugl Meyer scale	Baseline and 12 weeks	Change from baseline in Fugl Meyer scale.

Secondary Outcome Measures

Name	Time	Method
Change on Motor Function assessed by Wolf Motor Function scale	Baseline, 3 months and 12 months	Multiple changes from baseline in Wolf Motor Function scale.
Change on Motor Function assessed by Fugl Meyer scale	Baseline, 3 months and 12 months	Multiple changes from baseline in Fugl Meyer scale.
Change on Motor Function assessed by Robotic scale	Baseline, 3 months and 12 months	Multiple changes from baseline in robotic scale.
Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)	Baseline, 12 weeks, 3 months and 12 months	Multiple changes from baseline in AMAT scale.
Change on Functional Independence Measure (FIM) as assessed by FIM scale	Baseline, 12 weeks, 3 months and 12 months	Multiple changes from baseline in FIM scale.
Change on Quality of life assessed by Stroke Impact Scale (SIS)	Baseline, 12 weeks, 3 months and 12 months	Multiple changes from baseline in SIS.
Change on Kinematic variables assessed by InMotion robots	Baseline, 12 weeks, 3 months and 12 months	Multiple motion changes from baseline in the Kinematic variables assessed by InMotion robots.

Trial Locations

Locations (1)

Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP; 🇧🇷 Sao Paulo, Brazil