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

Stroke Clinical Trial

— NARLE1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02700061
• Other study ID #: 0910.0.015.000-11
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 24, 2015
• Last updated: March 1, 2016
• Start date: February 2012
• Est. completion date: February 2017

Study information

• Verified date: August 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Robotic occupational therapy
Robotic Occupational Therapy three times a week for twelve weeks.
• Induced Constraint Therapy - ICT
Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological Evaluation assessed by Perceived Stress Scale (PSS-10)	Multiple changes from baseline in PSS-10.	Baseline, 12 weeks, 3 months and 12 months	No
Other	Neuroplasticity as assessed by Brain Derived Neurotrophic Factor (BDNF)	Multiple changes from baseline in BDNF.	Baseline, 12 weeks, 3 months and 12 months	No
Other	Corticospinal excitability as assessed by transcranial magnetic stimulation (TMS)	Multiple changes from baseline in TMS.	Baseline, 12 weeks, 3 months and 12 months	No
Other	Neurologic evaluation as assessed by electroencephalography	Multiple changes from baseline in electroencephalography.	Baseline, 12 weeks, 3 months and 12 months	No
Primary	Change on Motor Function assessed by Wolf Motor Function scale	Change from baseline in Wolf Motor Function scale.	Baseline and 12 weeks	No
Primary	Change on Motor Function assessed by Fugl Meyer scale	Change from baseline in Fugl Meyer scale.	Baseline and 12 weeks	No
Secondary	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	No
Secondary	Change on Motor Function assessed by Fugl Meyer scale	Multiple changes from baseline in Fugl Meyer scale.	Baseline, 3 months and 12 months	No
Secondary	Change on Motor Function assessed by Robotic scale	Multiple changes from baseline in robotic scale.	Baseline, 3 months and 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No