Clinical trial NCT02700061: Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Keywords: Induced Constraint Therapy
Robotic Occupational Therapy
Neuroplasticity
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change on Motor Function assessed by Wolf Motor Function scale
timeFrame: Baseline and 12 weeks
measure: Change on Motor Function assessed by Fugl Meyer scale
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change on Motor Function assessed by Wolf Motor Function scale
timeFrame: Baseline, 3 months and 12 months
measure: Change on Motor Function assessed by Fugl Meyer scale
timeFrame: Baseline, 3 months and 12 months
measure: Change on Motor Function assessed by Robotic scale
timeFrame: Baseline, 3 months and 12 months
measure: Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)
timeFrame: Baseline, 12 weeks, 3 months and 12 months
measure: Change on Functional Independence Measure (FIM) as assessed by FIM scale
timeFrame: Baseline, 12 weeks, 3 months and 12 months
measure: Change on Quality of life assessed by Stroke Impact Scale (SIS)
timeFrame: Baseline, 12 weeks, 3 months and 12 months
measure: Change on Kinematic variables assessed by InMotion robots
timeFrame: Baseline, 12 weeks, 3 months and 12 months
Other outcomes:
measure: Psychological Evaluation assessed by Perceived Stress Scale (PSS-10)
timeFrame: Baseline, 12 weeks, 3 months and 12 months
measure: Neuroplasticity as assessed by Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Baseline, 12 weeks, 3 months and 12 months
measure: Corticospinal excitability as assessed by transcranial magnetic stimulation (TMS)
timeFrame: Baseline, 12 weeks, 3 months and 12 months
measure: Neurologic evaluation as assessed by electroencephalography
timeFrame: Baseline, 12 weeks, 3 months and 12 months
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
Study officials:
affiliation: University of Sao Paulo
name: Linamara Rizzo Battistella, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.