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

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

Sponsors

Lead sponsor: University of Sao Paulo General Hospital

Source 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

Overall Status Unknown status
Start Date February 2012
Completion Date February 2017
Primary Completion Date April 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change on Motor Function assessed by Wolf Motor Function scale Baseline and 12 weeks
Change on Motor Function assessed by Fugl Meyer scale Baseline and 12 weeks
Secondary Outcome
Measure Time Frame
Change on Motor Function assessed by Wolf Motor Function scale Baseline, 3 months and 12 months
Change on Motor Function assessed by Fugl Meyer scale Baseline, 3 months and 12 months
Change on Motor Function assessed by Robotic scale Baseline, 3 months and 12 months
Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT) Baseline, 12 weeks, 3 months and 12 months
Change on Functional Independence Measure (FIM) as assessed by FIM scale Baseline, 12 weeks, 3 months and 12 months
Change on Quality of life assessed by Stroke Impact Scale (SIS) Baseline, 12 weeks, 3 months and 12 months
Change on Kinematic variables assessed by InMotion robots Baseline, 12 weeks, 3 months and 12 months
Enrollment 51
Condition
Intervention

Intervention type: Procedure

Intervention name: Robotic occupational therapy

Description: Robotic Occupational Therapy three times a week for twelve weeks.

Arm group label: Robotic occupational therapy

Other name: Robotic therapy

Intervention type: Procedure

Intervention name: Induced Constraint Therapy - ICT

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

Arm group label: Induced Constraint Therapy - ICT

Other name: 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Linamara Rizzo Battistella, Md PhD Principal Investigator University of Sao Paulo
Location
facility
Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
Location Countries

Brazil

Verification Date

August 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Induced Constraint Therapy - ICT

Arm group type: Experimental

Description: 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.

Arm group label: Robotic occupational therapy

Arm group type: Experimental

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

Acronym NARLE1
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov