Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
Primary Purpose
FESD, Rehabilitation, Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FES-C
Standard Treatment
Sponsored by
About this trial
This is an interventional treatment trial for FESD
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FES-C
Standard
Arm Description
Outcomes
Primary Outcome Measures
Incremental Cost-Effectiveness Ratio
QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€
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
Secondary Outcome Measures
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
Costs
the costs of the two treatments could variate from 0 to 50'000 €
Muscle tone
Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity
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).
Full Information
NCT ID
NCT04592679
First Posted
September 28, 2020
Last Updated
October 12, 2020
Sponsor
Azienda Ospedaliero, Universitaria Pisana
1. Study Identification
Unique Protocol Identification Number
NCT04592679
Brief Title
Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
Official Title
FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
July 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FESD, Rehabilitation, Spinal Cord Injuries, Complete Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FES-C
Arm Type
Experimental
Arm Title
Standard
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
FES-C
Intervention Description
The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Intervention Description
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 Outcome Measure Information:
Title
Incremental Cost-Effectiveness Ratio
Description
QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€
Time Frame
3 years
Title
Thigh Circumferences
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Quality Adjusted Life Years (QALYs)
Description
It consists in the use of a scale 0 (death) - 1 (the best possible state of health) for the improvements of the patients
Time Frame
3 years
Title
Costs
Description
the costs of the two treatments could variate from 0 to 50'000 €
Time Frame
3 years
Title
Muscle tone
Description
Muscle tone evaluated with "Modified Ashworth Scale" (MAS), 0-5 points, an higher result means more spasticity
Time Frame
3 years
Title
Sensation of pain
Description
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).
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
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