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

NCT02700061 | Unknown Phase 2 DMC

• 1 other identifier: 0910.0.015.000-11
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Induced Constraint Therapy; Robotic Occupational Therapy; Neuroplasticity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Other Outcomes (4)

• Psychological Evaluation assessed by Perceived Stress Scale (PSS-10)

  Baseline, 12 weeks, 3 months and 12 months

• Neuroplasticity as assessed by Brain Derived Neurotrophic Factor (BDNF)

  Baseline, 12 weeks, 3 months and 12 months

• Corticospinal excitability as assessed by transcranial magnetic stimulation (TMS)

  Baseline, 12 weeks, 3 months and 12 months

Study Arms (2)

Induced Constraint Therapy - ICT

EXPERIMENTAL

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

Robotic occupational therapy

EXPERIMENTAL

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

Procedure: Robotic occupational therapy

Interventions

Robotic occupational therapy PROCEDURE

Robotic Occupational Therapy three times a week for twelve weeks.

Also known as: Robotic therapy

Robotic occupational therapy

Induced Constraint Therapy - ICT PROCEDURE

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

Also known as: ICT

Induced Constraint Therapy - ICT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP

São Paulo, São Paulo, 04116-040, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34366819 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Linamara Rizzo Battistella, Md PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: March 7, 2016
• Study Start: February 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 7, 2016

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)