StrokeNCT04249349
Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors
A study testing Assisted gait with a motorized ankle foot orthosis in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
Trial summary
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Assisted gait with a motorized ankle foot orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 27 Sep 2019to 11 Nov 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiparesis caused by a stroke.
- Age between 18 and 65 years old.
- Post-stroke time more than 6 months.
- Independent walking.
- Minimum 90 degrees of dorsiflexion.
- Muscle tone in plantar flexors less than of equal to 3 on the Modified Ashworth scale.
- Ability to follow instructions.
- Voluntary participation.
Who cannot join
- Skin alterations in the lower limb.
- Peripherical vascular alterations.
- Alterations in sensitivity in the lower limb.
- Pain of musculoskeletal origin in lower extremities or spine.
- History of frequent falls.
- Cancer
- Previous history or suspected seizures.
- Patient who does not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, Region of Magallanes, 6211525
About this study
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Read the detailed description
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis.
The device is composed by a passive orthosis structure which allows one degree of freedom (DOF) among the sagittal plane and it includes two servomotors attached to the user's foot through velcro strips.
Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
- Conditions
- Stroke
- Being tested
- Assisted gait with a motorized ankle foot orthosis
- Keywords
- Stroke, Ankle foot orthosis, Gait, Active orthosis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted gait with a motorized ankle foot orthosisDevice
The motorized ankle foot orthosis is a powered lower extremity assistance device with an actuated ankle joint. A novel control software has been design and implemented in this device, which allows precise joint movement and recording of data from training session.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Gait | Experimental | Participants will receive assisted gait with a motorized ankle foot orthosis. Patient´s gait will be analyzed by a photogrammetry system during device assistance. Session will involve 1 hour of supervised training. Receives: Device: Assisted gait with a motorized ankle foot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Deviation Index without assistance
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: Baseline
Gait Deviation Index assisted by motorized ankle foot orthosis
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Measured: Day 1
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start27 Sep 2019
- Primary completion4 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249349
- Sponsor's protocol ID
- CorporacionRCLCS0003
- Status last verified
- Jul 2020
- First submitted
- 29 Jan 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pennycott A, Wyss D, Vallery H, Klamroth-Marganska V, Riener R. Towards more effective robotic gait training for stroke rehabilitation: a review. J Neuroeng Rehabil. 2012 Sep 7;9:65. doi: 10.1186/1743-0003-9-65.
PubMed 22953989Nadeau S, Duclos C, Bouyer L, Richards CL. Guiding task-oriented gait training after stroke or spinal cord injury by means of a biomechanical gait analysis. Prog Brain Res. 2011;192:161-80. doi: 10.1016/B978-0-444-53355-5.00011-7.
PubMed 21763525Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.
PubMed 28157752Shi B, Chen X, Yue Z, Yin S, Weng Q, Zhang X, Wang J, Wen W. Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. Front Neurorobot. 2019 Aug 13;13:63. doi: 10.3389/fnbot.2019.00063. eCollection 2019.
PubMed 31456681Young AJ, Ferris DP. State of the Art and Future Directions for Lower Limb Robotic Exoskeletons. IEEE Trans Neural Syst Rehabil Eng. 2017 Feb;25(2):171-182. doi: 10.1109/TNSRE.2016.2521160. Epub 2016 Jan 27.
PubMed 26829794
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors
- ClinicalTrials.gov ID
- NCT04249349
- Acronym / sponsor ID
- CorporacionRCLCS0003
- Conditions
- Stroke
- Keywords
- Stroke, Ankle foot orthosis, Gait, Active orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del SurUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 30 Jan 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.
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Detailed description
This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis.
The device is composed by a passive orthosis structure which allows one degree of freedom (DOF) among the sagittal plane and it includes two servomotors attached to the user's foot through velcro strips.
Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Gait | Experimental | Device: Assisted gait with a motorized ankle foot orthosisParticipants will receive assisted gait with a motorized ankle foot orthosis. Patient´s gait will be analyzed by a photogrammetry system during device assistance. Session will involve 1 hour of supervised training. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hemiparesis caused by a stroke.
- Age between 18 and 65 years old.
- Post-stroke time more than 6 months.
- Independent walking.
- Minimum 90 degrees of dorsiflexion.
Key exclusion criteria (8 listed)
- Skin alterations in the lower limb.
- Peripherical vascular alterations.
- Alterations in sensitivity in the lower limb.
- Pain of musculoskeletal origin in lower extremities or spine.
- History of frequent falls.
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 |
|---|---|---|
| Assisted gait with a motorized ankle foot orthosisThe motorized ankle foot orthosis is a powered lower extremity assistance device with an actuated ankle joint. A novel control software has been design and implemented in this device, which allows precise joint movement and recording of data from training session. | Device | Robot-assisted Gait |
Primary outcome
Gait Deviation Index without assistance
Time frame: Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index assisted by motorized ankle foot orthosis
Time frame: Day 1
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
Time frame: Day 1
Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction
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 14 Jul 2020.
- Background: PubMed 22953989Pennycott A, Wyss D, Vallery H, Klamroth-Marganska V, Riener R. Towards more effective robotic gait training for stroke rehabilitation: a review. J Neuroeng Rehabil. 2012 Sep 7;9:65. doi: 10.1186/1743-0003-9-65.
- Background: PubMed 21763525Nadeau S, Duclos C, Bouyer L, Richards CL. Guiding task-oriented gait training after stroke or spinal cord injury by means of a biomechanical gait analysis. Prog Brain Res. 2011;192:161-80. doi: 10.1016/B978-0-444-53355-5.00011-7.
- Background: PubMed 28157752Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.
- Background: PubMed 31456681Shi B, Chen X, Yue Z, Yin S, Weng Q, Zhang X, Wang J, Wen W. Wearable Ankle Robots in Post-stroke Rehabilitation of Gait: A Systematic Review. Front Neurorobot. 2019 Aug 13;13:63. doi: 10.3389/fnbot.2019.00063. eCollection 2019.
- Background: PubMed 26829794Young AJ, Ferris DP. State of the Art and Future Directions for Lower Limb Robotic Exoskeletons. IEEE Trans Neural Syst Rehabil Eng. 2017 Feb;25(2):171-182. doi: 10.1109/TNSRE.2016.2521160. Epub 2016 Jan 27.
- 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 Assisted gait with a motorized ankle foot orthosis in people with Stroke, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
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 14 Jul 2020. 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 Chile. 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?
Gait Deviation Index without assistance (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT04249349, which also lists 5 linked publications.
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 14 Jul 2020.