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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2020-07-21

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.

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Detailed Description

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Conditions

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FESD Rehabilitation Spinal Cord Injuries Complete Spinal Cord Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FES-C

Group Type EXPERIMENTAL

FES-C

Intervention Type DEVICE

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

Standard

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type OTHER

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'.

Interventions

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FES-C

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

Intervention Type DEVICE

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'.

Intervention Type OTHER

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