Parkinson DiseasePaDAWAnNCT04314973
PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
A study testing Active Pelvis Orthosis and Walking exercises in people with Parkinson Disease, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Active Pelvis Orthosis and Walking exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Jan 2022to Jun 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease diagnosis positive according to UK Brain Bank criteria
- Hoehn and Yahr score of 1 to 3
- Mini-mental state (MMSE) higher than 24
- Optimal drug treatment for at least 4 weeks at the time of inclusion
- No contraindication to physical exercising (ACSM criteria)
Who cannot join
- Not being able to understand French well enough
- Not being in the targeted age range
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis.
Read the detailed description
None of the existing robotic devices used for gait rehabilitation in Parkinson's disease is wearable. Thanks to the wearable robotic pelvis orthosis we will use, the rehabilitation sessions can take place in an ecological environment.
The other advantage of the proposed assistance protocol is its adaptability: patients will feel their hips pattern to be "smoothed" by the robot, but they will keep the freedom of continuously steering their main movement variables (like stride frequency, duration, and length). A key measured metric will precisely rely on this variability between stride durations. Indeed, the degree of stride-to-stride variability was shown to reflect the patient's physiological state, and to be correlated with the stage of the disease.
Experimental trials will be conducted to assess both the assistive (i.e. the therapy effect during the therapy itself) and rehabilitative (i.e. effect after the therapy) natures of our protocol. The second main objective of this project will be the analysis of the effects of our protocol regarding the stride-to-stride variability of patients with Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Active Pelvis Orthosis, Walking exercises
- Keywords
- Exoskeleton, Active Pelvis Orthosis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Pelvis OrthosisDevice
Walking with the robotic device providing the assistive protocol.
Walking exercisesOther
Walking exercises without wearing the robotic device.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation sessions | Active comparator | Patients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after. Receives: Other: Walking exercises |
| Intervention phase | Experimental | Patients will walk with the robotic device, for 12 sessions of 10 min. Receives: Device: Active Pelvis Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-Range Autocorrelation (LRA)
Assesses the variability between stride durations
Measured: From day 0 up to 8 weeks
Secondary outcomes (7)
Unified Parkinson's disease rating scales (UPDRS)
Assesses the disease stage and severity
Measured: From day 0 up to 8 weeks
Activities-Specific Balance Confidence Scale (ABC)
Self reported measure of balance confidence in performing various activities
Measured: From day 0 up to 8 weeks
Balance Evaluation Systems Test (BESTest)
The balance of subjects is tested during 6 postural control contexts
Measured: From day 0 up to 8 weeks
Gait analysis
Average stride length and duration, gait symmetry, hips range of motion
Measured: From day 0 up to 8 weeks
Joint torques
In order to assess the mechanical efforts associated to walking
Measured: From day 0 up to 8 weeks
Physiological Cost Index
In order to assess the metabolic efforts associated to walking
Measured: From day 0 up to 8 weeks
System Usability Scale (SUS)
Self reported measure of the fatigue and stress felt by patients
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start27 Jan 2022
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314973
- Sponsor's protocol ID
- PaDAWAn
- Acronym
- PaDAWAn
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otlet V, Vandamme C, Warlop T, Crevecoeur F, Ronsse R. Effects of overground gait training assisted by a wearable exoskeleton in patients with Parkinson's disease. J Neuroeng Rehabil. 2023 Nov 16;20(1):156. doi: 10.1186/s12984-023-01280-y.
PubMed 37974229
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaDAWAn: Parkinson's Disease - Adaptive Walking Assistance
- ClinicalTrials.gov ID
- NCT04314973
- Acronym / sponsor ID
- PaDAWAn / PaDAWAn
- Conditions
- Parkinson Disease
- Keywords
- Exoskeleton, Active Pelvis Orthosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Mar 2020 (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 study is to develop and validate a haptic assistive method in order to support walking in patients with Parkinson's disease, delivered to the patient's hips through a wearable robotic pelvis orthosis.
Detailed description
None of the existing robotic devices used for gait rehabilitation in Parkinson's disease is wearable. Thanks to the wearable robotic pelvis orthosis we will use, the rehabilitation sessions can take place in an ecological environment.
The other advantage of the proposed assistance protocol is its adaptability: patients will feel their hips pattern to be "smoothed" by the robot, but they will keep the freedom of continuously steering their main movement variables (like stride frequency, duration, and length). A key measured metric will precisely rely on this variability between stride durations. Indeed, the degree of stride-to-stride variability was shown to reflect the patient's physiological state, and to be correlated with the stage of the disease.
Experimental trials will be conducted to assess both the assistive (i.e. the therapy effect during the therapy itself) and rehabilitative (i.e. effect after the therapy) natures of our protocol. The second main objective of this project will be the analysis of the effects of our protocol regarding the stride-to-stride variability of patients with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation sessions | Active comparator | Other: Walking exercisesPatients will be evaluated while walking without wearing the robotic device, once before the intervention phase, once right after, and once a month after. |
| Intervention phase | Experimental | Device: Active Pelvis OrthosisPatients will walk with the robotic device, for 12 sessions of 10 min. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease diagnosis positive according to UK Brain Bank criteria
- Hoehn and Yahr score of 1 to 3
- Mini-mental state (MMSE) higher than 24
- Optimal drug treatment for at least 4 weeks at the time of inclusion
- No contraindication to physical exercising (ACSM criteria)
Key exclusion criteria (2 listed)
- Not being able to understand French well enough
- Not being in the targeted age range
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 |
|---|---|---|
| Active Pelvis OrthosisWalking with the robotic device providing the assistive protocol. | Device | Intervention phase |
| Walking exercisesWalking exercises without wearing the robotic device. | Other | Evaluation sessions |
Primary outcome
Long-Range Autocorrelation (LRA)
Time frame: From day 0 up to 8 weeks
Assesses the variability between stride durations
7 secondary outcomes
Unified Parkinson's disease rating scales (UPDRS)
Time frame: From day 0 up to 8 weeks
Activities-Specific Balance Confidence Scale (ABC)
Time frame: From day 0 up to 8 weeks
Balance Evaluation Systems Test (BESTest)
Time frame: From day 0 up to 8 weeks
Gait analysis
Time frame: From day 0 up to 8 weeks
Joint torques
Time frame: From day 0 up to 8 weeks
Physiological Cost Index
Time frame: From day 0 up to 8 weeks
System Usability Scale (SUS)
Time frame: After 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 37974229Otlet V, Vandamme C, Warlop T, Crevecoeur F, Ronsse R. Effects of overground gait training assisted by a wearable exoskeleton in patients with Parkinson's disease. J Neuroeng Rehabil. 2023 Nov 16;20(1):156. doi: 10.1186/s12984-023-01280-y.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Pelvis Orthosis and Walking exercises in people with Parkinson Disease, run by Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
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?
Long-Range Autocorrelation (LRA) (time frame: From day 0 up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314973, which also lists 1 linked publication.
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 21 Jun 2022.