PURO - PUlmonary Rehabilitation With O-RAGT Platform

NCT05757830 | Completed

• 1 other identifier: 825003
• Study Type: interventional
• Target: 20
• Locations: 4 countries
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Walking meters change during 4 minute walking test

  4 minutes walking test on a 20-meter corridor

  Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)

Secondary Outcomes (12)

• Number of repetitions change in one-minute sit to stand test

  Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)

• Average VO2 change during 4 minute walking test

  Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)

• O2 cost of walking change during 4 minute walking test

  Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)

• Net metabolic power change during 4 minute walking test

  Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)

• Physiological cost index (PCI) change during 4 minute walking test

  Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)

Study Arms (1)

Exoskeleton-assisted arm

EXPERIMENTAL

Each subject will perform 3 experimental conditions with and without the exoskeleton to assess the impact of exoskeleton assisted walking on metabolic consumption and cardiorespiratory effort compared to conventional overground walking training without an exoskeleton

Device: UANGO suite exoskeleton

Interventions

UANGO suite exoskeleton DEVICE

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.

Exoskeleton-assisted arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to perform 4 minutes of back-and-forth locomotion with assistance or resting periods;
• Height between 160 and 195 cm;
• Weight not exceeding 100 kg;
• Diagnosis of Multiple Sclerosis with moderate to severe disability (5,5 \< EDSS \< 8,0);
• Diagnosis of stroke or traumatic brain damage (1 ≤ FAC ≤ 3);
• Diagnosis of spinal cord injury with neurological level of injury\<T2 (3 ≤ WISCI II ≤ 16) with a Asia Impairment Score B, C or D.
• Able to perform 4 minutes of back-and-forth locomotion with assistance or resting periods;
• Able to use walker;

You may not qualify if:

• Impairments in the upper limbs that do not allow the user to hold the crutches/walker.
• Skin injuries in the areas where the exoskeleton is in contact with the user.
• Fractures not solved or bone pathologies in lower limbs in which the use of the exoskeleton could be risky (advanced osteoporosis).
• Psychiatric or cognitive problems that can interfere with the correct use of the device.
• Important muscle/joint retractions in lower limbs (Modified Ashworth Scale \> 3).
• Any medical conditions that could interfere with the autonomic cardiovascular control (e.g severe diabetes).
• Use of beta blocker drugs.
• Presence of severe cardiovascular diseases.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Roessingh Research and Development: collaborator
• Hospital Nacional de Parapléjicos de Toledo: collaborator
• Lithuanian University of Health Sciences: collaborator

Study Sites (4)

Fondazione Don Carlo Gnocchi

Milan, MI, 20162, Italy

Location

Lithuanian University of Health Sciences

Kaunas, LT-50161, Lithuania

Location

Roessingh Research and Development

Enschede, AH, 7522, Netherlands

Location

Hospital Nacional de Parapléjicos de Toledo

Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Spinal Cord Injuries; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 7, 2023
• Study Start: December 23, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-01

Locations

IT (1); NL (1); ES (1); LI (1)