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Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients (RiSES)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MeCFES-assisted task-oriented upper limb rehabilitation
Usual Care task-oriented upper limb rehabilitation
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Functional Electrical Stimulation, Cerebrovascular accident, Stroke, Electromyography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke
  • at least 1 month post-stroke
  • willingness to participate the project
  • minimum voluntary muscle activation of shoulder flexors (>1 Manual Muscle Test)
  • passive Range of Motion (ROM) of the shoulder and elbow of more than 90°

Exclusion Criteria:

  • epilepsy
  • severe spasticity at upper limb (>= 3 Ashworth scale)
  • implanted electronic device
  • respiratory insufficiency
  • pregnancy
  • peripheral neuropathies
  • cutaneous ulcers at the stimulation zone
  • other use of FES on the upper limb

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MeCFES

    Control

    Arm Description

    25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation

    25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation

    Outcomes

    Primary Outcome Measures

    Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
    ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.
    Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment
    FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome

    Secondary Outcome Measures

    Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
    IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000). IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.
    Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
    DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.
    Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment
    VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).

    Full Information

    First Posted
    January 11, 2017
    Last Updated
    September 27, 2018
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    Istituto Di Ricerche Farmacologiche Mario Negri
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03019744
    Brief Title
    Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients
    Acronym
    RiSES
    Official Title
    Studio Clinico di Efficacia Della Stimolazione Elettrica Funzionale Controllata da Segnale Elettromiografico Nel Trattamento Dell'Arto Superiore in Pazienti Con Esiti di Ictus Cerebrovascolare (Progetto Rises)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus
    Collaborators
    Istituto Di Ricerche Farmacologiche Mario Negri

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Functional Electrical Stimulation, Cerebrovascular accident, Stroke, Electromyography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MeCFES
    Arm Type
    Experimental
    Arm Description
    25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
    Intervention Type
    Device
    Intervention Name(s)
    MeCFES-assisted task-oriented upper limb rehabilitation
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care task-oriented upper limb rehabilitation
    Primary Outcome Measure Information:
    Title
    Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
    Description
    ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.
    Time Frame
    5 weeks (post-treatment vs pre-treatment)
    Title
    Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment
    Description
    FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome
    Time Frame
    5 weeks (post-treatment vs pre-treatment)
    Secondary Outcome Measure Information:
    Title
    Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
    Description
    IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000). IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.
    Time Frame
    5 weeks (post-treatment vs pre-treatment)
    Title
    Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
    Description
    DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.
    Time Frame
    5 weeks (post-treatment vs pre-treatment)
    Title
    Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment
    Description
    VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).
    Time Frame
    5 weeks (post-treatment vs pre-treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke at least 1 month post-stroke willingness to participate the project minimum voluntary muscle activation of shoulder flexors (>1 Manual Muscle Test) passive Range of Motion (ROM) of the shoulder and elbow of more than 90° Exclusion Criteria: epilepsy severe spasticity at upper limb (>= 3 Ashworth scale) implanted electronic device respiratory insufficiency pregnancy peripheral neuropathies cutaneous ulcers at the stimulation zone other use of FES on the upper limb
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maurizio Ferrarin, PhD
    Organizational Affiliation
    Fondazione Don Carlo Gnocchi Onlus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12392340
    Citation
    van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
    Results Reference
    background
    PubMed Identifier
    1135616
    Citation
    Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
    Results Reference
    background
    Citation
    Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15
    Results Reference
    background
    Citation
    Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.
    Results Reference
    background

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    Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

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