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Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke (RehaMSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208634
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
National Research Council of Italy
Information provided by (Responsible Party):
Dr. Franco Molteni, Villa Beretta Rehabilitation Center

Brief Summary:
Robotic rehabilitation is promising to promote function in stroke patients. The assist as needed training paradigm has shown to stimulate neuroplasticity but often cannot be used because stroke patients are too impaired to actively control the robot against gravity. Aim of this study is to present a novel robotic approach based on fully assisted functional movements and to examine the effect of the intervention in terms of motor function improvement in subjects with chronic stroke in the short term and at 6-month follow up. A preliminary evaluation of the effectiveness of the intervention in improving activity and participation in the short term is also performed. Further, the study aims to verify whether some instrumental measures (using kinematics, EMG and EEG) may help gain insight into the mechanisms leading to improved motor ability following the robotic intervention and can be used to predict functional recovery.

Condition or disease Intervention/treatment Phase
Chronic Stroke Device: Robotic intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: La Riabilitazione Robot Assistita Del Paziente Neurologico: l'Elettromiografia Dinamica di Superficie Come Strumento Per la Personalizzazione Del Trattamento
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Robotic intervention
Robotic intervention.
Device: Robotic intervention
One-month robotic intervention. Twelve sessions, three sessions a week, 40 minutes each. Twenty minutes of fully assisted reaching + 20 minutes of assisted Hand-to-Mouth




Primary Outcome Measures :
  1. Change in Upper-Extremity Fugl-Meyer Assessment [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Function domain


Secondary Outcome Measures :
  1. Change in Wolf Motor Function Test (WMFT) [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Activity domain

  2. Change in Motor Activity Log [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Participation domain


Other Outcome Measures:
  1. Change in Modified Research Council [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Strength assessment

  2. Change in Modified Ashworth Scale [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Spasticity assessment

  3. Change in The Clinical Global Impression Scale of Severity and Improvement [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Severity of psychopathology and improvement

  4. Change in Draw a Person Test [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Body awareness

  5. Change in NASA -Task Load Index [ Time Frame: 1 week; 4 weeks ]
    Task load

  6. Change in movement duration [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Average Hand-to-Mouth and Reaching movement durations

  7. Change in ROM [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Average maximum elbow flexion during Hand-to-Mouth movement and maximum shoulder flexion and elbow extension during the Reaching movement

  8. Change in joint angular velocity [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Average maximum elbow flexion velocity

  9. Change in movement smoothness [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Average normalized jerk computed on the wrist kinematics during Hand-to-Mouth and Reaching movements

  10. Change in movement repeatability [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    Coefficient of periodicity computed on the wrist kinematics during Hand-to-Mouth and Reaching movements

  11. Change in movement efficiency [ Time Frame: Baseline; 4 weeks; 6-month follow up ]
    The effort index calculated on the shoulder. It is an energetic parameter, which is derived from the shoulder torque.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemiplegia after first stroke;
  • time from the stroke event > 6 months;
  • absence of severe attentive deficits;
  • ability to perform active arm movements (shoulder flexion MRC > 1 and AROM > 60°, elbow flexion-extension MRC >1 and AROM > 90°) and able to hold the robot handle,
  • Modified Ashworth Scale score ≤ 3 (see section outcome)

Exclusion Criteria:

  • other concurrent upper-limb rehabilitation interventions;
  • presence of global aphasia and/or cognitive impairments that could interfere with
  • understanding the instructions during evaluation and treatment.
  • concomitant progressive central nervous system disorders, peripheral nervous system disorders or myopathies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208634


Locations
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Italy
Villa Beretta Rehabilitation Center
Costa Masnaga, Lecco, Italy, 23845
Sponsors and Collaborators
Villa Beretta Rehabilitation Center
National Research Council of Italy
Investigators
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Principal Investigator: Franco Molteni Villa Beretta Rehab Center
Publications of Results:
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Responsible Party: Dr. Franco Molteni, Clinical Director, Villa Beretta Rehabilitation Center
ClinicalTrials.gov Identifier: NCT03208634    
Other Study ID Numbers: 0043622/14U
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Franco Molteni, Villa Beretta Rehabilitation Center:
robotics
motor performance
stroke patient
upper limb
rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases