Complete Spinal Cord Injury, FESD, Rehabilitation, Spinal Cord Injuries
Conditions
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.
Interventions
DEVICEFES-C
The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.
OTHERStandard 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'.
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Cost-Effectiveness Ratio | 3 years | QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€ |
| Thigh Circumferences | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality Adjusted Life Years (QALYs) | 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 | 3 years | the costs of the two treatments could variate from 0 to 50'000 € |
| Muscle tone | 3 years | Muscle tone evaluated with Modified Ashworth Scale (MAS), 0-5 points, an higher result means more spasticity |
| Sensation of pain | 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). |
Outcome results
None listed