Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
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|ClinicalTrials.gov Identifier: NCT04592679|
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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'.
- 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
- 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).