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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592679
• Other study ID #: 3879B
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: July 21, 2020

Study information

• Verified date: October 2020
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 21, 2020
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Spinal Cord Injury
• FESD
• Rehabilitation
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• FES-C
The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.

Other:
• Standard 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'.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Cost-Effectiveness Ratio	QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€	3 years
Primary	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	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
Secondary	Costs	the costs of the two treatments could variate from 0 to 50'000 €	3 years
Secondary	Muscle tone	Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity	3 years
Secondary	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