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

Active, not recruiting

Phase 2 Results N/A

Trial Description

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

Interventions

  • Robotic occupational therapy Procedure
    Other Names: Robotic therapy
    Intervention Desc: Robotic Occupational Therapy three times a week for twelve weeks.
    ARM 1: Kind: Experimental
    Label: Robotic occupational therapy
    Description: Physical rehabilitation with Robotic occupational therapy. Robotic Occupational Therapy three times a week for twelve weeks.
  • Induced Constraint Therapy - ICT Procedure
    Other Names: ICT
    Intervention Desc: Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
    ARM 1: Kind: Experimental
    Label: Induced Constraint Therapy - ICT
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change on Motor Function assessed by Wolf Motor Function scale Baseline and 12 weeks No
Primary Change on Motor Function assessed by Fugl Meyer scale Baseline and 12 weeks No
Secondary Change on Motor Function assessed by 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) Baseline, 12 weeks, 3 months and 12 months No
Secondary Change on Functional Independence Measure (FIM) as assessed by FIM scale Baseline, 12 weeks, 3 months and 12 months No
Secondary Change on Quality of life assessed by Stroke Impact Scale (SIS) Baseline, 12 weeks, 3 months and 12 months No
Secondary Change on Kinematic variables assessed by InMotion robots Baseline, 12 weeks, 3 months and 12 months No

Sponsors