StrokeH2-NeuroExoNCT02114450
Human-Machine System for the H2 Lower Limb Exoskeleton
A study testing Robot-assisted training with the H2 lower limb powered exoskeleton and Supervised motor practice in people with Stroke and Hemiparesis, run by University of Houston at 2 sites in United States.
Trial summary
This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Robot-assisted training with the H2 lower limb powered exoskeleton and Supervised motor practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2015to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
- Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score > 24 points, out of a total 30 indicating normal cognitive ability);
- Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
- Modified Ashworth Scale of Spasticity score <= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
- Have no skin integrity issues;
- Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);
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- Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.
- Able to understand and sign the consent form
- Age 18-75 years
Who cannot join
- Severe cognitive and/or visual deficit;
- Hemineglect (determined based on medical record or initial clinical assessment);
- Severe sensory deficit;
- Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
- Skin lesions that may hinder or prevent the application of exoskeleton;
- Uncontrolled angina;
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- Severe chronic obstructive pulmonary disease;
- Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.
- History of neurological, neuromuscular or physical disability.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
TIRR Memorial Hermann Hospital
Houston, Texas, 77056
Gerard E Francisco, MD, 713-797-5244, gerard.e.francisco@uth.tmc.edu
Shuo-Hsiu Chang, PT, PhD, 713-799-7016, Shuo-Hsiu.Chang@uth.tmc.edu
- Recruiting
University of Houston
Houston, Texas, 77204
Jose L Contreras-Vidal, PhD, 713-743-4429, jlcontreras-vidal@uh.edu
Jose L Contreras-Vidal, PhD
About this study
Official title: Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation
This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.
Read the detailed description
Stroke is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Gait impairment is a large contributor to long-term disability and ambulatory function in daily living. Many patients, however, lose the ability to walk independently, and furthermore, a large proportion does not regain their normal walking speeds following a stroke. In this context, newer robotic-aided therapeutic tools such as "wearable" lower-limb robotic exoskeletons have been developed, which allow for the user to be augmented by mechanically actuated lower limb joints that can either completely or partially assist movements of the lower limb segments depending on the patient needs.
The H2 exoskeleton (developed by Technaid S.L., Spain) is an example of one such system that has hip, knee and ankle joints actuated for both lower limbs. These devices are very new, and therefore, systematic investigations of therapeutic benefits of these devices are lacking in the field. Further, the nature of plasticity in the brain triggered by wearing and training such exoskeletons is unknown. In this exploratory research study, the investigators aim to compare robotic-assisted rehabilitation using the H2 exoskeleton with supervised motor practice particularly in terms of functional recovery. Additionally, this study will also examine brain plasticity associated with robotic-assisted training using non-invasive scalp electroencephalography (EEG) and changes in lower limb joint kinematics during robotic-assisted training. Taken together, the findings from this research will be used to understand human-robot interaction and to design smart powered orthotic devices that can be controlled directly by brain activity and assist those that have lost all or part of their walking abilities due to neurological disease or injury. Moreover, this study will systematically track neuroplasticity associated with functional recovery after stroke, which will help determine optimal windows for treatment that would maximize therapeutic benefit. Lastly, it will also help characterize markers of learning to use these new devices, which will be important in the clinical setting for modifying and adapting rehabilitation protocols to suit changing needs of the patient (user).
- Conditions
- Stroke, Hemiparesis
- Being tested
- Robot-assisted training with the H2 lower limb powered exoskeleton, Supervised motor practice
- Keywords
- Stroke, Paresis, Gait rehabilitation, Human-Machine Interaction, Wearable Robotic Devices
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted training with the H2 lower limb powered exoskeletonBehavioural
The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.
Supervised motor practiceBehavioural
Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours. Receives: Behavioral: Robot-assisted training with the H2 lower limb powered exoskeleton |
| Supervised motor practice | Active comparator | Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours. Receives: Behavioral: Supervised motor practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function
This test evaluates and measures recovery in post-stroke hemiplegic patients, used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the Balance component of the F-M scale (0;con not perform; 1:can perform partially; 2:can perform fully). The total score ranges from 0 to 34, with higher scores representing better function.
Measured: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change from baseline in Functional Gait Assessment
This scale assesses postural stability during various walking tasks using a 10-item test with each item scored from 0 to 3 (0 = severe impairment and 3 = normal ambulation). This test has high criterion validity to assess functional status in stroke patients, and has been shown to be responsive to measure change.
Measured: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change from baseline in Lower limb joint kinematics during walking
Lower limb joint kinematics (bilateral hip, knee and ankle joints) will be assessed through surface motion sensors placed on the skin during walking. This assessment will help study and characterize subtle changes in lower limb kinematics pre- and post-intervention.
Measured: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change in cortical dynamics measured by Electroencephalography (EEG)
Time and frequency domain analysis will be performed on scalp EEG signals to characterize changes in cortical dynamics, specifically in gait initiation and sensory-motor cortical networks. Additionally, we will also evaluate the extent to which lower limb kinematics during gait can be reconstructed from scalp EEG of the user. This will be used to evaluate the neural basis of changes in lower limb joint motion as well as develop EEG-based brain-machine interfaces to robotic exoskeletons.
Measured: Each Experimental/Training Session (12 visits) over the 4 week training period
Secondary outcomes (4)
Change in robotic measure of performance measured by the H2
The amount of assistance provided by robotic joint motors will be monitored across treatment sessions. This will help better understand human-robotic interaction while walking with the H2, and also help characterize changes in human adaptation while using the device.
Measured: Each Experimental/Training Session (12 visits) over the 4 week training period
Change from baseline in Berg Balance Scale score
A 14-item objective measure designed to assess static balance and fall risk in adult populations, with maximum summed score of 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
Measured: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change from baseline in distance walked during the 6-minute walk test
This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. It has good responsiveness to detect improvements in capacity to walk in stroke patients.
Measured: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change from baseline in Timed Up and Go Test score
This test assesses mobility, balance, walking ability, and fall risk in older adults. Scores range from 1 to 5 based on the observer's perception of the patient's risk of falling. This test has been used in assessing stroke recovery with high reliability and validity.
Measured: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start20 Nov 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, TIRR Memorial Hermann
- Responsible party
- Principal investigator, Jose L.Contreras-Vidal, Ph.D., University of Houston
- Investigators
- Jose L Contreras-Vidal, PhD, Principal investigator, University of HoustonGerard E Francisco, MD, Principal investigator, TIRR Memorial Hermann HospitalJose L Pons, PhD, Principal investigator, Spanish Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114450
- Sponsor's protocol ID
- 14107
- Other IDs
- HSC-MS-14-0129
- Acronym
- H2-NeuroExo
- Status last verified
- Oct 2024
- First submitted
- 8 Apr 2014
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
M. Bortole and J.L. Pons, "Development of a Exoskeleton for Lower Limb Rehabilitation," in Converging Clinical and Engineering Research on Neurorehabilitation Biosystems & Biorobotics vol. 1, no. 14, Berlin, Heidelberg: Springer Berlin Heidelberg, 2013, pp. 85-90
Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.
PubMed 26076696Contreras-Vidal JL, Bortole M, Zhu F, Nathan K, Venkatakrishnan A, Francisco GE, Soto R, Pons JL. Neural Decoding of Robot-Assisted Gait During Rehabilitation After Stroke. Am J Phys Med Rehabil. 2018 Aug;97(8):541-550. doi: 10.1097/PHM.0000000000000914.
PubMed 29481376
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation
- ClinicalTrials.gov ID
- NCT02114450
- Acronym / sponsor ID
- H2-NeuroExo / 14107
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Paresis, Gait rehabilitation, Human-Machine Interaction, Wearable Robotic Devices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, TIRR Memorial Hermann
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- 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 study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.
Detailed description
Stroke is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Gait impairment is a large contributor to long-term disability and ambulatory function in daily living. Many patients, however, lose the ability to walk independently, and furthermore, a large proportion does not regain their normal walking speeds following a stroke. In this context, newer robotic-aided therapeutic tools such as "wearable" lower-limb robotic exoskeletons have been developed, which allow for the user to be augmented by mechanically actuated lower limb joints that can either completely or partially assist movements of the lower limb segments depending on the patient needs.
The H2 exoskeleton (developed by Technaid S.L., Spain) is an example of one such system that has hip, knee and ankle joints actuated for both lower limbs. These devices are very new, and therefore, systematic investigations of therapeutic benefits of these devices are lacking in the field. Further, the nature of plasticity in the brain triggered by wearing and training such exoskeletons is unknown. In this exploratory research study, the investigators aim to compare robotic-assisted rehabilitation using the H2 exoskeleton with supervised motor practice particularly in terms of functional recovery. Additionally, this study will also examine brain plasticity associated with robotic-assisted training using non-invasive scalp electroencephalography (EEG) and changes in lower limb joint kinematics during robotic-assisted training. Taken together, the findings from this research will be used to understand human-robot interaction and to design smart powered orthotic devices that can be controlled directly by brain activity and assist those that have lost all or part of their walking abilities due to neurological disease or injury. Moreover, this study will systematically track neuroplasticity associated with functional recovery after stroke, which will help determine optimal windows for treatment that would maximize therapeutic benefit. Lastly, it will also help characterize markers of learning to use these new devices, which will be important in the clinical setting for modifying and adapting rehabilitation protocols to suit changing needs of the patient (user).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Rehabilitation | Experimental | Behavioral: Robot-assisted training with the H2 lower limb powered exoskeletonParticipants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours. |
| Supervised motor practice | Active comparator | Behavioral: Supervised motor practiceParticipants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
- Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score > 24 points, out of a total 30 indicating normal cognitive ability);
- Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
- Modified Ashworth Scale of Spasticity score <= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
- Have no skin integrity issues;
Key exclusion criteria (9 listed)
- Severe cognitive and/or visual deficit;
- Hemineglect (determined based on medical record or initial clinical assessment);
- Severe sensory deficit;
- Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
- Skin lesions that may hinder or prevent the application of exoskeleton;
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 |
|---|---|---|
| Robot-assisted training with the H2 lower limb powered exoskeletonThe H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs. | Behavioural | Robot-assisted Rehabilitation |
| Supervised motor practiceSupervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist. | Behavioural | Supervised motor practice |
Primary outcome
Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function
Time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
This test evaluates and measures recovery in post-stroke hemiplegic patients, used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the Balance component of the F-M scale (0;con not perform; 1:can perform partially; 2:can perform fully). The total score ranges from 0 to 34, with higher scores representing better function.
Change from baseline in Functional Gait Assessment
Time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
This scale assesses postural stability during various walking tasks using a 10-item test with each item scored from 0 to 3 (0 = severe impairment and 3 = normal ambulation). This test has high criterion validity to assess functional status in stroke patients, and has been shown to be responsive to measure change.
Change from baseline in Lower limb joint kinematics during walking
Time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Lower limb joint kinematics (bilateral hip, knee and ankle joints) will be assessed through surface motion sensors placed on the skin during walking. This assessment will help study and characterize subtle changes in lower limb kinematics pre- and post-intervention.
Change in cortical dynamics measured by Electroencephalography (EEG)
Time frame: Each Experimental/Training Session (12 visits) over the 4 week training period
Time and frequency domain analysis will be performed on scalp EEG signals to characterize changes in cortical dynamics, specifically in gait initiation and sensory-motor cortical networks. Additionally, we will also evaluate the extent to which lower limb kinematics during gait can be reconstructed from scalp EEG of the user. This will be used to evaluate the neural basis of changes in lower limb joint motion as well as develop EEG-based brain-machine interfaces to robotic exoskeletons.
4 secondary outcomes
Change in robotic measure of performance measured by the H2
Time frame: Each Experimental/Training Session (12 visits) over the 4 week training period
Change from baseline in Berg Balance Scale score
Time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change from baseline in distance walked during the 6-minute walk test
Time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Change from baseline in Timed Up and Go Test score
Time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- BackgroundM. Bortole and J.L. Pons, "Development of a Exoskeleton for Lower Limb Rehabilitation," in Converging Clinical and Engineering Research on Neurorehabilitation Biosystems & Biorobotics vol. 1, no. 14, Berlin, Heidelberg: Springer Berlin Heidelberg, 2013, pp. 85-90
- Results publication: PubMed 26076696Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.
- Results publication: PubMed 29481376Contreras-Vidal JL, Bortole M, Zhu F, Nathan K, Venkatakrishnan A, Francisco GE, Soto R, Pons JL. Neural Decoding of Robot-Assisted Gait During Rehabilitation After Stroke. Am J Phys Med Rehabil. 2018 Aug;97(8):541-550. doi: 10.1097/PHM.0000000000000914.
- University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)Link provided by the sponsor.
- The UTHealth Center for Wearable Exoskeletons at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)Link provided by the sponsor.
- 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.
Jose L Contreras-Vidal, PhD principal investigator
University of Houston
Gerard E Francisco, MD principal investigator
TIRR Memorial Hermann Hospital
Jose L Pons, PhD principal investigator
Spanish Research Council
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted training with the H2 lower limb powered exoskeleton and Supervised motor practice in people with Stroke and Hemiparesis, run by University of Houston at 2 sites in United States.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose L Contreras-Vidal, PhD (713-743-4429, jlcontreras-vidal@UH.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function (time frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months). The study lists 4 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 NCT02114450, which also lists 3 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 30 Oct 2024.