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

Study Overview
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Brief Summary
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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.

Official Title
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FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals

Conditions
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FESD, Rehabilitation, Spinal Cord Injuries, Complete Spinal Cord Injury

Intervention / Treatment
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* Device: FES-C
* Other: Standard Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FES-C<br> | Device: FES-C<br>* The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.<br>|
| Active Comparator: Standard<br> | Other: Standard Treatment<br>* 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'.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Cost-Effectiveness Ratio | QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€ | 3 years | 
| 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 
| Costs | the costs of the two treatments could variate from 0 to 50'000 € | 3 years | 
| Muscle tone | Muscle tone evaluated with Modified Ashworth Scale (MAS), 0-5 points, an higher result means more spasticity | 3 years | 
| 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). | 3 years |