Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity (NARLE1)

Effects of Upper Limb Motor Training and Upper Limb Robotic Training Over Neuroplasticity and Function Capacity: A Single-blind Randomized Clinical Trial With Patients With Stroke Sequelae

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Procedure: Induced Constraint Therapy - ICT; Procedure: Robotic occupational therapy

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04116-040
    • Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Induced Constraint Therapy - ICT; Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.; Other Names: ICT
Experimental: Robotic occupational therapy; Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks.	Procedure: Robotic occupational therapy; Robotic Occupational Therapy three times a week for twelve weeks.; Other Names: Robotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on Motor Function assessed by Wolf Motor Function scale	Change from baseline in Wolf Motor Function scale.	Baseline and 12 weeks
Change on Motor Function assessed by Fugl Meyer scale	Change from baseline in Fugl Meyer scale.	Baseline and 12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Evaluation assessed by Perceived Stress Scale (PSS-10)	Multiple changes from baseline in PSS-10.	Baseline, 12 weeks, 3 months and 12 months
Neuroplasticity as assessed by Brain Derived Neurotrophic Factor (BDNF)	Multiple changes from baseline in BDNF.	Baseline, 12 weeks, 3 months and 12 months
Corticospinal excitability as assessed by transcranial magnetic stimulation (TMS)	Multiple changes from baseline in TMS.	Baseline, 12 weeks, 3 months and 12 months
Neurologic evaluation as assessed by electroencephalography	Multiple changes from baseline in electroencephalography.	Baseline, 12 weeks, 3 months and 12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Linamara Rizzo Battistella, Md PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Estimate): March 7, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Neuroplasticity; Induced Constraint Therapy; Robotic Occupational Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 0910.0.015.000-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO