Multiple SclerosisPURONCT05757830
PURO - PUlmonary Rehabilitation With O-RAGT Platform
A study testing UANGO suite exoskeleton in people with Multiple Sclerosis and Spinal Cord Injury, run by Fondazione Don Carlo Gnocchi ETS at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis, Spinal Cord Injury, Stroke
- What is being tested?
- UANGO suite exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 23 Dec 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Metabolic Consumption, Cardiorespiratory Effort, Cardiac Autonomic Control and Fatigability During Exoskeleton-assisted (the U&O Suite) sit-to Stand Maneuver and Walking in People With Neurological Diseases With Moderate to Severe Gait Disability.
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.
Read the detailed description
In people with severe gait impairments due to neurological diseases walk recovery is one primary goal, since achieving independent ambulation is a major contributing factor to their quality of life. Beyond walking, other very common Activities of Daily Living (ADL), such as postural transitions (which requires an integrity of the autonomic control mechanisms of blood pressure) and stair climbing (which requires the necessary strength in the lower limbs to lift one's own body weight) should be guaranteed by any rehabilitative intervention. Although physiotherapy treatments have proven effectiveness in improving gait and balance, conventional overground walking training may be very difficult or even impossible for patients with moderate to severe gait problems and limited cardiovascular capacity due to a too high energy demand (exercise intensity) (Calabrò 2022).
Wearable powered exoskeletons could be used to provide overground robotic assisted gait training (RAGT). Indeed, RAGT has shown clinically significant improvements in gait and balance outcomes and could be considered a valid approach to enhance gait function in people with severe gait impairments due to neurological diseases(Bowman 2021).
Little is known about the impact of robotic training on cardiovascular parameters and the metabolic / energy cost of walking with a wearable powered exoskeleton compared to unassisted overground walking in population with neurological diseases. It is possible that exoskeletons allow walking while keeping cardiorespiratory effort under control with a lower metabolic cost.
Moreover, people with severe gait impairments can suffer from disturbed cardiac autonomic control during exercise which affects exercise tolerance and balance during orthostatic challenges, such as the sit-to-stand maneuver. Indeed, to recommend RAGT in people with neurological diseases with moderate to severe gait impairments, the impact of the cardiac autonomic tone on sit-to-standing and walking with an exoskeleton should be investigated.
The use of an assisted as needed exoskeleton in clinical practice with population with moderate-severe neurological disabilities could increase their locomotor function by reducing the impact on metabolic consumption and cardiorespiratory effort compared to conventional overground walking training without an exoskeleton. Moreover, cardiovascular autonomic dysfunction (CAD), if any, should not be worsened by walking with an exoskeleton compared to conventional overground walking training, and should not constitute an impediment in the adaptation of the cardiovascular adaptation (especially of blood pressure) to the postural transitions.
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
- Being tested
- UANGO suite exoskeleton
- Medical subject headings
- Multiple Sclerosis, Spinal Cord Injuries, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UANGO suite exoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: UANGO suite exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking meters change during 4 minute walking test
4 minutes walking test on a 20-meter corridor
Measured: 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
The one-minute sit to stand test is performed with a chair of standard height without arm rests. The patient is ensured to be seated upright on the chair. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips. Every get up from one's chair was validated to check if complete sit-to-stand-to-sit sequence was achieved.
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Average VO2 change during 4 minute walking test
Metabolic-related variables measured with K5-Cosmed device during 4 minute walking test on a 20-meter corridor
Measured: 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
Metabolic-related variables measured with K5-Cosmed device during 4 minute walking test on a 20-meter corridor
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Net metabolic power change during 4 minute walking test
Metabolic-related variables measured with K5-Cosmed device during 4 minute walking test on a 20-meter corridor
Measured: 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
Metabolic-related variables measured with PCI scale during 4 minute walking test on a 20-meter corridor
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Average heart rate change during 4 minute walking test
Cardiorespiratory parameters measured with pulse oximeter device during 4 minute walking test on a 20-meter corridor
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Heart rate increase change during 4 minute walking test
Cardiorespiratory parameters measured with pulse oximeter device during 4 minute walking test on a 20-meter corridor
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Rating of perceived exertion of lower limbs change before and after each trials
Fatigue-related parameters using the Borg scale scoring system ranging from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion".
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Rating of perceived exertion of breath change before and after each trials
Fatigue-related parameters using the Borg scale scoring system ranging from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion".
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Assessment of device usability at the end of each condition
Usability will be assessed with the System Usability Scale (SUS). SUS consists of a 10 item questionnaire with five response options for respondents; from "strongly agree" to "strongly disagree".
Measured: Baseline (Condition 2) and after 24 hours (Condition 3)
Assessment of users satisfaction at the end of each condition
Satisfaction will be assessed with Telehealth satisfaction questionnaire (TSQWT). The TSQWT contains six subscales evaluating the benefit, usability, self-concept, privacy and loss of control, quality of life and wearing comfort of the system. Each subscale includes five questions rated on a 5-point Likert scale between 0 (I strongly disagree) and 4 (I strongly agree). The total score ranges between 0 (no satisfaction) and 120 (extreme satisfaction).
Measured: Baseline (Condition 2) and after 24 hours (Condition 3)
Assessment of the work load change during each trials
Task load will be assessed with Nasa Task Load Index. NASA (TLX) method assesses work load on five 7-point scales. Increments of high, medium and low.
Measured: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start23 Dec 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Roessingh Research and Development, Hospital Nacional de Parapléjicos de Toledo, Lithuanian University of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757830
- Sponsor's protocol ID
- 825003
- Acronym
- PURO
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Consumption, Cardiorespiratory Effort, Cardiac Autonomic Control and Fatigability During Exoskeleton-assisted (the U&O Suite) sit-to Stand Maneuver and Walking in People With Neurological Diseases With Moderate to Severe Gait Disability.
- ClinicalTrials.gov ID
- NCT05757830
- Acronym / sponsor ID
- PURO / 825003
- Conditions
- Multiple Sclerosis, Spinal Cord Injury, Stroke, Traumatic Brain Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Roessingh Research and Development, Hospital Nacional de Parapléjicos de Toledo, Lithuanian University of Health Sciences
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In people with severe gait impairments due to neurological diseases walk recovery is one primary goal, since achieving independent ambulation is a major contributing factor to their quality of life. Beyond walking, other very common Activities of Daily Living (ADL), such as postural transitions (which requires an integrity of the autonomic control mechanisms of blood pressure) and stair climbing (which requires the necessary strength in the lower limbs to lift one's own body weight) should be guaranteed by any rehabilitative intervention. Although physiotherapy treatments have proven effectiveness in improving gait and balance, conventional overground walking training may be very difficult or even impossible for patients with moderate to severe gait problems and limited cardiovascular capacity due to a too high energy demand (exercise intensity) (Calabrò 2022).
Wearable powered exoskeletons could be used to provide overground robotic assisted gait training (RAGT). Indeed, RAGT has shown clinically significant improvements in gait and balance outcomes and could be considered a valid approach to enhance gait function in people with severe gait impairments due to neurological diseases(Bowman 2021).
Little is known about the impact of robotic training on cardiovascular parameters and the metabolic / energy cost of walking with a wearable powered exoskeleton compared to unassisted overground walking in population with neurological diseases. It is possible that exoskeletons allow walking while keeping cardiorespiratory effort under control with a lower metabolic cost.
Moreover, people with severe gait impairments can suffer from disturbed cardiac autonomic control during exercise which affects exercise tolerance and balance during orthostatic challenges, such as the sit-to-stand maneuver. Indeed, to recommend RAGT in people with neurological diseases with moderate to severe gait impairments, the impact of the cardiac autonomic tone on sit-to-standing and walking with an exoskeleton should be investigated.
The use of an assisted as needed exoskeleton in clinical practice with population with moderate-severe neurological disabilities could increase their locomotor function by reducing the impact on metabolic consumption and cardiorespiratory effort compared to conventional overground walking training without an exoskeleton. Moreover, cardiovascular autonomic dysfunction (CAD), if any, should not be worsened by walking with an exoskeleton compared to conventional overground walking training, and should not constitute an impediment in the adaptation of the cardiovascular adaptation (especially of blood pressure) to the postural transitions.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton-assisted arm | Experimental | Device: UANGO suite exoskeletonEach 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UANGO suite exoskeletonEach 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. | Device | Exoskeleton-assisted arm |
Primary outcome
Walking meters change during 4 minute walking test
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
4 minutes walking test on a 20-meter corridor
12 secondary outcomes
Number of repetitions change in one-minute sit to stand test
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Average VO2 change during 4 minute walking test
Time frame: 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
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Net metabolic power change during 4 minute walking test
Time frame: 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
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Average heart rate change during 4 minute walking test
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Heart rate increase change during 4 minute walking test
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Rating of perceived exertion of lower limbs change before and after each trials
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Rating of perceived exertion of breath change before and after each trials
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Assessment of device usability at the end of each condition
Time frame: Baseline (Condition 2) and after 24 hours (Condition 3)
Assessment of users satisfaction at the end of each condition
Time frame: Baseline (Condition 2) and after 24 hours (Condition 3)
Assessment of the work load change during each trials
Time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UANGO suite exoskeleton in people with Multiple Sclerosis and Spinal Cord Injury, run by Fondazione Don Carlo Gnocchi ETS at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Lithuania, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking meters change during 4 minute walking test (time frame: Baseline (Condition 1) and after 24 hours (Condition 2) and after 48 hours (Condition 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.