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

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.

Condition or disease Intervention/treatment Phase
FESD Rehabilitation Spinal Cord Injuries Complete Spinal Cord Injury Device: FES-C Other: Standard Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : July 21, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FES-C Device: FES-C
The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.

Active Comparator: Standard 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'.

Primary Outcome Measures :
  1. 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/€

  2. 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

Secondary Outcome Measures :
  1. 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

  2. Costs [ Time Frame: 3 years ]
    the costs of the two treatments could variate from 0 to 50'000 €

  3. Muscle tone [ Time Frame: 3 years ]
    Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity

  4. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Matteo Olivieri, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana Identifier: NCT04592679    
Other Study ID Numbers: 3879B
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System