Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04592679
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Matteo Olivieri, Azienda Ospedaliero, Universitaria Pisana

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE January 1, 2015
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • Incremental Cost-Effectiveness Ratio [ Time Frame: 3 years ]
    QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€
  • Thigh Circumferences [ Time Frame: 3 years ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • Quality Adjusted Life Years (QALYs) [ Time Frame: 3 years ]
    It consists in the use of a scale 0 (death) - 1 (the best possible state of health) for the improvements of the patients
  • Costs [ Time Frame: 3 years ]
    the costs of the two treatments could variate from 0 to 50'000 €
  • Muscle tone [ Time Frame: 3 years ]
    Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity
  • Sensation of pain [ Time Frame: 3 years ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
Official Title  ICMJE FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • FESD
  • Rehabilitation
  • Spinal Cord Injuries
  • Complete Spinal Cord Injury
Intervention  ICMJE
  • Device: FES-C
    The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.
  • Other: Standard Treatment
    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'.
Study Arms  ICMJE
  • Experimental: FES-C
    Intervention: Device: FES-C
  • Active Comparator: Standard
    Intervention: Other: Standard Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2020)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 21, 2020
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592679
Other Study ID Numbers  ICMJE 3879B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Matteo Olivieri, Azienda Ospedaliero, Universitaria Pisana
Study Sponsor  ICMJE Azienda Ospedaliero, Universitaria Pisana
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliero, Universitaria Pisana
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP