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Completed

NCT Number: NCT04592679

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

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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Key information

Conditions

FESD Central Nervous System Diseases Complete Spinal Cord Injury Nervous System Diseases Rehabilitation Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FES-C

Device

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

standard treatment

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'.

Primary outcomes

  1. Incremental Cost-Effectiveness Ratio

    Time frame: 3 years

    QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€

  2. Thigh Circumferences

    Time frame: 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 outcomes

  1. Quality Adjusted Life Years (QALYs)

    Time frame: 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

  2. Costs

    Time frame: 3 years

    the costs of the two treatments could variate from 0 to 50'000 €

  3. Muscle tone

    Time frame: 3 years

    Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity

  4. Sensation of pain

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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