NCT05811884

Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the efficacy of the use of powered exoskeleton for ambulation on the quality of life in subjects with spinal cord injury. The main questions it aims to answer are: 1. How much does the use of powered exoskeleton improve the quality of life in subjects with spinal cord injury after a 24 months treatment period in a house context (treatment 1) or in a clinical setting (treatment 2)? 2. How much do the two treatments differ in terms of cost-utility ratio? Participants will be included in a multi-step process consisting of: 1. Recruitment, based on eligibility criteria; 2. Observation of the "stability" over time (2 months) of specific clinical parameters; 3. Training in the use of the powered exoskeleton (1 month); 4. Random selection of the rehabilitation treatment (house rehabilitation or central rehabilitation); concerning the house rehabilitation, the subject will be provided the device for home use; concerning the central rehabilitation, the subject will be asked to use intensively the device 1-week every three months in a clinical facility. 5. Follow-up: every six months each subject will be asked to attend a single-day activities session consisting of walking activities with the exoskeleton, compilation of questionnaires, sub-maximal effort test with arm-ergometer, and physical examinations made by a physiatrist.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Rehabilitation	The subjects will be provided of the powered exoskeleton for home use. No specific indications will be provided, but using the technology as much as possible. The subjects will be asked to attend to periodic rehabilitation sessions by the clinical facility. The rehabilitation session will consist in an intense 1-week activities session every three months. Every six months, the subjects will be asked to attend a single-day session by the clinical facility (follow-up session) consisting on the assessement of a series of qualitative and quantitative measurements.

Timeline

• Start date: 2030-01-01
• Primary completion: 2033-01-01
• Completion: 2033-02-01
• First posted: 2023-04-13
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy