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

NCT04592679 | Completed

• 1 other identifier: 3879B
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

FESD; Rehabilitation; Spinal Cord Injuries; Complete Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Incremental Cost-Effectiveness Ratio

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

  3 years

• 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 Outcomes (4)

• Quality Adjusted Life Years (QALYs)

  3 years

• Costs

  3 years

• Muscle tone

  3 years

• Sensation of pain

  3 years

Study Arms (2)

FES-C

EXPERIMENTAL

Device: FES-C

Standard

ACTIVE COMPARATOR

Other: Standard Treatment

Interventions

FES-C DEVICE

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

FES-C

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'.

Standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cognitive deficits
• psychiatric diseases
• cancer
• recent fractures

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: July 21, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10