PURO - PUlmonary Rehabilitation With O-RAGT Platform
NCT05757830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-06-15
Summary
The goal of this interventional study is to assess differences in the metabolic consumption, the cardiorespiratory effort, the cardiac autonomic adaptation, and fatigability during ADL, such as standing from a chair and walking while wearing an electrically powered exoskeleton in different modes of supports in subjects with neurological diseases with moderate to severe walking impairments.
Conditions
- Multiple Sclerosis
- Spinal Cord Injury
- Stroke
- Traumatic Brain Damage
Interventions
- DEVICE
-
UANGO suite exoskeleton
Each subject will perform 3 experimental conditions (Condition 1: Walking without exoskeleton; Condition 2: Walking with exoskeleton; Condition 3: Walking with exoskeleton and walker). Each condition includes 5 triasl (Trial 1 - Sitting: 5 minutes, sitting at rest in comfortable position; Trial 2 - Standing: 5 minutes, with assistance; Trial 3 - Comfortable speed Walking (100% assisted): 4 min during back-and-forth locomotion on a 20-m length linear flat path; Trial 4 - Comfortable speed Walking (75% assistance): 4 min during back-and-forth locomotion on a 20-m length linear flat path, Trial 4 is not available in condition 1; Trial 5 - 1 minute Sit to stand test). Nasa TLX and RPE will be requested at the end of each trial. Usability questionnaires will be fullfilled at the end of condition 2 and condition 3.
Sponsors & Collaborators
-
Roessingh Research and Development
collaborator OTHER -
Hospital Nacional de Parapléjicos de Toledo
collaborator OTHER -
Lithuanian University of Health Sciences
collaborator OTHER -
Fondazione Don Carlo Gnocchi Onlus
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-23
- Primary Completion
- 2023-03-31
- Completion
- 2023-03-31
Countries
- Italy
- Lithuania
- Netherlands
- Spain
Study Locations
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