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Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI

Primary Purpose

FESD, Rehabilitation, Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FES-C
Standard Treatment
Sponsored by
Azienda Ospedaliero, Universitaria Pisana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for FESD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • complete spinal cord injury
  • loss of gait function
  • any episode of autonomic dysreflexia
  • any important range of motion limitation to hips, knees or ankles
  • eccitability of the muscles
  • FES tollerability

Exclusion Criteria:

  • cognitive deficits
  • psychiatric diseases
  • cancer
  • recent fractures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FES-C

    Standard

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incremental Cost-Effectiveness Ratio
    QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€
    Thigh Circumferences
    The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, the raging of the improvement could be from 0 to 50 cm

    Secondary Outcome Measures

    Quality Adjusted Life Years (QALYs)
    It consists in the use of a scale 0 (death) - 1 (the best possible state of health) for the improvements of the patients
    Costs
    the costs of the two treatments could variate from 0 to 50'000 €
    Muscle tone
    Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity
    Sensation of pain
    Sensation of pain evaluated with "International Spinal Cord Injury - Pain Basic Data Set" 0-30 points, an higher result means more sensation of pain (ISCI-P).

    Full Information

    First Posted
    September 28, 2020
    Last Updated
    October 12, 2020
    Sponsor
    Azienda Ospedaliero, Universitaria Pisana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04592679
    Brief Title
    Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
    Official Title
    FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    July 21, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliero, Universitaria Pisana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    20 patients were recruited by two hospitals (AOUP and AOUC) in Italy from January 2015 to January 2018. The participants have been addressed to two different groups: the ones recruited by the AOUP were submitted to an experimental protocol of rehabilitation with FES Cycling, the ones recruited by the AOUC were submitted to a standard protocol of manual mobilization. The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, while the secondary outcomes were the muscle tone evaluated with Modified Ashworth Scale (MAS) and the sensation of pain registered with International Spinal Cord Injury - Pain Basic Data Set (ISCI-P). From these outcomes the Quality Adjusted Life Years (QALYs) was obtained. The costs of the two treatments were calculated through a consultation process with the Competent Offices of the two hospitals. The QALYs and the costs were used to calculate the Incremental Cost-Effectiveness Ratio (ICER) in order to verify the cost-effectiveness ratio of the two treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    FESD, Rehabilitation, Spinal Cord Injuries, Complete Spinal Cord Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FES-C
    Arm Type
    Experimental
    Arm Title
    Standard
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    FES-C
    Intervention Description
    The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Treatment
    Intervention Description
    The participants were submitted to 20 sessions of standard rehabilitation for lower limbs with manual mobilization, three/five times per week. Each session lasted about 30'.
    Primary Outcome Measure Information:
    Title
    Incremental Cost-Effectiveness Ratio
    Description
    QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€
    Time Frame
    3 years
    Title
    Thigh Circumferences
    Description
    The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, the raging of the improvement could be from 0 to 50 cm
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Quality Adjusted Life Years (QALYs)
    Description
    It consists in the use of a scale 0 (death) - 1 (the best possible state of health) for the improvements of the patients
    Time Frame
    3 years
    Title
    Costs
    Description
    the costs of the two treatments could variate from 0 to 50'000 €
    Time Frame
    3 years
    Title
    Muscle tone
    Description
    Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity
    Time Frame
    3 years
    Title
    Sensation of pain
    Description
    Sensation of pain evaluated with "International Spinal Cord Injury - Pain Basic Data Set" 0-30 points, an higher result means more sensation of pain (ISCI-P).
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: complete spinal cord injury loss of gait function any episode of autonomic dysreflexia any important range of motion limitation to hips, knees or ankles eccitability of the muscles FES tollerability Exclusion Criteria: cognitive deficits psychiatric diseases cancer recent fractures

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI

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