FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Primary Endpoint
- Thigh Circumferences
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
- •recent fractures
Outcomes
Primary Outcomes
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
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/€
Secondary Outcomes
- Quality Adjusted Life Years (QALYs)(3 years)
- Costs(3 years)
- Muscle tone(3 years)
- Sensation of pain(3 years)
Investigators
Matteo Olivieri
Principal Investigator
Azienda Ospedaliero, Universitaria Pisana