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

Not Applicable

Completed

• Conditions: Complete Spinal Cord Injury; FESD; Rehabilitation; Spinal Cord Injuries
• Interventions: Device: FES-C; Other: Standard Treatment

• Registration Number: NCT04592679
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2020-07-21
• Study First Submitted: 2020-09-28
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FES-C	FES-C	-
Standard	Standard Treatment	-

Primary Outcome Measures

Name	Time	Method
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
Incremental Cost-Effectiveness Ratio	3 years	QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€

Secondary Outcome Measures

Name	Time	Method
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).