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

Azienda Ospedaliero, Universitaria Pisana

Status: Completed

Conditions: Complete Spinal Cord Injury; Rehabilitation; Spinal Cord Injuries; FESD

Treatments: Device: FES-C; Other: Standard Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04592679

3879B

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

FES-C

Experimental group

Treatment:

Device: FES-C

Standard

Active Comparator group

Treatment:

Other: Standard Treatment