StrokeNCT05241457
Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.
An observational study of Stroke and Stroke, Acute, run by Sunnyview Rehabilitation Hospital at 1 site in United States.
Trial summary
The Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Cerebrovascular Accident
- What is being tested?
- Ekso gait training and Standard physical therapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 11 Mar 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient Rehabilitation Facility
Who may be able to join
- Inpatient at Sunnyview Rehabilitation Hospital
- Right or left hemispheric stroke
- >18 years of age
Who cannot join
- No paresis
- Paraplegia
- Quadriplegia
- FAC of 2,3 or 4
- Weight > 220 lbs (Ekso manufacturer criteria)
- Height > 6'4" (Ekso manufacturer criteria)
Show all 14Show fewer
- > 3 months post stroke onset
- Comorbidities affecting gait (LE fractures, Parkinson's, Severe Polyneuropathy)
- LE/sacral wounds that come into contact with the Ekso
- LE contractures that cannot be accommodated by Ekso
- Prior Stroke
- Weight Bearing Restrictions 8
- Unable to follow 1-2 step commands.
- Contact precautions for COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
The Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic and subacute period following stroke (Goffredo et al., 2019; Molteni et al., 2017; Molteni et al., 2021; Nam et al., 2019; Rojek, 2019).
Exoskeleton-assisted gait training during acute inpatient rehabilitation provides a means for patients to actively participate in gait training during the early and most severe stages of stroke recovery. Most acute inpatient rehabilitation facilities (IRFs) report a feasibility of 5-8 Ekso sessions during inpatient stays and demonstrate significant improvement from baseline (Nolan et al., 2020; Swank, 2020). Nolan et al. (2020) demonstrated that stroke patients receiving Ekso ambulated 1640 feet more than patients undergoing more conventional gait training techniques during inpatient rehabilitation, suggesting that the exoskeleton may offer additional benefit during this phase of recovery. Despite promising evidence, there have been no randomized controlled trials within the IRF setting.
Read more
Because Ekso-gait training increases the number of steps patients can take, during acute inpatient physical therapy (PT), the investigators hypothesize that patients who participate in Ekso-gait training will demonstrate quicker improvements in balance, gait speed, endurance and independence in functional ambulation during their stay in the IRF.
In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or Ekso-gait training therapy. Meaningful clinical benchmarks for balance and walking will be assessed using the Berg Balance Scale (BBS) (Alghadir, 2018; Moore, 2018), the 10 Meter Walk Test (10MWT) (Bowden, 2008; Moore, 2018), the Six Minute Walk Test (6MWT) (Kubo et al., 2020; Moore, 2018), and Functional Ambulation Category (FAC) (Mehrholz, 2007). Achieving these benchmark scores are associated with several positive outcomes, including increased ability to ambulate in the community and reduced risk of falling (Alghadir, 2018; Bowden, 2008; Kubo et al., 2020). The investigators also hypothesize that patients in the Ekso cohort will report greater value/usefulness when compared to patients receiving standard care.
- Being tested
- Ekso gait training, Standard physical therapy
- Keywords
- Exoskeleton, Gait training, Inpatient rehabilitation, Ekso gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ekso gait trainingDevice
Ekso sessions will be 60 minutes each. Patients will be measured to optimize Ekso fit during their initial training session. Ekso settings will be progressed as deemed appropriate by the trained clinician. The progression of Ekso settings allows the patient to use their maximum effort while the Ekso assists only as much as the patient requires to complete stepping. Patients may also spend time working on pre-gait activities and balance activities including weight shifting, stepping in place, side-stepping and backwards ambulation based on the patient's needs as determined by the clinician.
Standard physical therapyProcedure or surgery
Standard physical therapy sessions will be 60 to 90 minutes a day. Clinicians typically focus on gait, balance, and strengthening activities that address goals related to functional mobility. Other devices that would normally be used during PT sessions, including the Lite Gait and Rifton tram body weight support devices and electrical stimulation devices including the XCITE and RT300 (from Restorative Therapies).
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | Patients will receive the standard physical therapy sessions that they would normally receive during their IRF stay, (60 to 90 min sessions, 5 to 6 days/week). This group will not receive Ekso exoskeleton gait training. Receives: Procedure: Standard physical therapy | |
| Ekso exoskeleton gait training group | Patients in the Ekso group will have several (2 to 3) of their standard of care sessions replaced with Ekso gait training sessions each week. Receives: Device: Ekso gait training; Procedure: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test at self-selected speed (10MWT, SSS)
Used to assess walking speed over a short distance at the patient's chosen speed.
Measured: T1 (Day 14-16)
10-meter walk test at self-selected speed (10MWT, SSS)
Used to assess walking speed over a short distance at the patient's chosen speed.
Measured: T2 (Day 20-22)
10-meter walk test at self-selected speed (10MWT, SSS)
Used to assess walking speed over a short distance at the patient's chosen speed.
Measured: T3 (Day 27-29)
10-meter walk test at fast speed (10MWT, fast)
Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
Measured: T1 (Day 14-16)
10-meter walk test at fast speed (10MWT, fast)
Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
Measured: T2 (Day 20-22)
10-meter walk test at fast speed (10MWT, fast)
Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
Measured: T3 (Day 27-29)
BERG Balance scale
A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements.
Measured: T1 (Day 14-16)
BERG Balance scale
A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements.
Measured: T2 (Day 20-22)
BERG Balance scale
A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements.
Measured: T3 (Day 27-29)
6-minute walk test (6MWT)
Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
Measured: T1 (Day 14-16)
6-minute walk test (6MWT)
Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
Measured: T2 (Day 20-22)
6-minute walk test (6MWT)
Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
Measured: T3 (Day 27-29)
Secondary outcomes (4)
Functional Ambulation Category (FAC)
A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Measured: T1 (Day 14-16)
Functional Ambulation Category (FAC)
A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Measured: T2 (Day 20-22)
Functional Ambulation Category (FAC)
A five-point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Measured: T3 (Day 27-29)
Intrinsic Motivation Inventory (IMI)
The value of the intervention as perceived by patients
Measured: T2 (Day 20-22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start11 Mar 2022
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnyview Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karah Lenge, Sunnyview Rehabilitation Hospital
- Investigators
- Karah Lenge, DPT, Principal investigator, Sunnyview Rehabilitation HospitalAllison Tallon, DPT, Principal investigator, Sunnyview Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241457
- Sponsor's protocol ID
- 21-1116-1
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.
PubMed 30213258Bowden MG, Balasubramanian CK, Behrman AL, Kautz SA. Validation of a speed-based classification system using quantitative measures of walking performance poststroke. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):672-5. doi: 10.1177/1545968308318837.
PubMed 18971382Goffredo M, Guanziroli E, Pournajaf S, Gaffuri M, Gasperini G, Filoni S, Baratta S, Damiani C, Franceschini M, Molteni F; Italian EksoGait Study Group. Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Eur J Phys Rehabil Med. 2019 Dec;55(6):710-721. doi: 10.23736/S1973-9087.19.05574-6. Epub 2019 Feb 4.
PubMed 30723189Kubo H, Nozoe M, Kanai M, Furuichi A, Onishi A, Kajimoto K, Mase K, Shimada S. Reference value of 6-minute walk distance in patients with sub-acute stroke. Top Stroke Rehabil. 2020 Jul;27(5):337-343. doi: 10.1080/10749357.2019.1704372. Epub 2019 Dec 18.
PubMed 31851872Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
PubMed 17908575Molteni F, Gasperini G, Gaffuri M, Colombo M, Giovanzana C, Lorenzon C, Farina N, Cannaviello G, Scarano S, Proserpio D, Liberali D, Guanziroli E. Wearable robotic exoskeleton for overground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results. Eur J Phys Rehabil Med. 2017 Oct;53(5):676-684. doi: 10.23736/S1973-9087.17.04591-9. Epub 2017 Jan 24.
PubMed 28118698Molteni F, Guanziroli E, Goffredo M, Calabro RS, Pournajaf S, Gaffuri M, Gasperini G, Filoni S, Baratta S, Galafate D, Le Pera D, Bramanti P, Franceschini M, On Behalf Of Italian Eksogait Study Group. Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects. Brain Sci. 2021 Jan 14;11(1):104. doi: 10.3390/brainsci11010104.
PubMed 33466749Moore JL, Potter K, Blankshain K, Kaplan SL, O'Dwyer LC, Sullivan JE. A Core Set of Outcome Measures for Adults With Neurologic Conditions Undergoing Rehabilitation: A CLINICAL PRACTICE GUIDELINE. J Neurol Phys Ther. 2018 Jul;42(3):174-220. doi: 10.1097/NPT.0000000000000229.
PubMed 29901487Nam YG, Lee JW, Park JW, Lee HJ, Nam KY, Park JH, Yu CS, Choi MR, Kwon BS. Effects of Electromechanical Exoskeleton-Assisted Gait Training on Walking Ability of Stroke Patients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jan;100(1):26-31. doi: 10.1016/j.apmr.2018.06.020. Epub 2018 Jul 25.
PubMed 30055163Nolan KJ, Karunakaran KK, Chervin K, Monfett MR, Bapineedu RK, Jasey NN, Oh-Park M. Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. Front Neurorobot. 2020 Oct 30;14:581815. doi: 10.3389/fnbot.2020.581815. eCollection 2020.
PubMed 33192438Rojek A, Mika A, Oleksy L, Stolarczyk A, Kielnar R. Effects of Exoskeleton Gait Training on Balance, Load Distribution, and Functional Status in Stroke: A Randomized Controlled Trial. Front Neurol. 2020 Jan 15;10:1344. doi: 10.3389/fneur.2019.01344. eCollection 2019.
PubMed 32010039Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
PubMed 30887864
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.
- ClinicalTrials.gov ID
- NCT05241457
- Acronym / sponsor ID
- 21-1116-1
- Keywords
- Exoskeleton, Gait training, Inpatient rehabilitation, Ekso gait training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sunnyview Rehabilitation HospitalUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 15 Feb 2022 (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 Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic and subacute period following stroke (Goffredo et al., 2019; Molteni et al., 2017; Molteni et al., 2021; Nam et al., 2019; Rojek, 2019).
Exoskeleton-assisted gait training during acute inpatient rehabilitation provides a means for patients to actively participate in gait training during the early and most severe stages of stroke recovery. Most acute inpatient rehabilitation facilities (IRFs) report a feasibility of 5-8 Ekso sessions during inpatient stays and demonstrate significant improvement from baseline (Nolan et al., 2020; Swank, 2020). Nolan et al. (2020) demonstrated that stroke patients receiving Ekso ambulated 1640 feet more than patients undergoing more conventional gait training techniques during inpatient rehabilitation, suggesting that the exoskeleton may offer additional benefit during this phase of recovery. Despite promising evidence, there have been no randomized controlled trials within the IRF setting.
Because Ekso-gait training increases the number of steps patients can take, during acute inpatient physical therapy (PT), the investigators hypothesize that patients who participate in Ekso-gait training will demonstrate quicker improvements in balance, gait speed, endurance and independence in functional ambulation during their stay in the IRF.
In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or Ekso-gait training therapy. Meaningful clinical benchmarks for balance and walking will be assessed using the Berg Balance Scale (BBS) (Alghadir, 2018; Moore, 2018), the 10 Meter Walk Test (10MWT) (Bowden, 2008; Moore, 2018), the Six Minute Walk Test (6MWT) (Kubo et al., 2020; Moore, 2018), and Functional Ambulation Category (FAC) (Mehrholz, 2007). Achieving these benchmark scores are associated with several positive outcomes, including increased ability to ambulate in the community and reduced risk of falling (Alghadir, 2018; Bowden, 2008; Kubo et al., 2020). The investigators also hypothesize that patients in the Ekso cohort will report greater value/usefulness when compared to patients receiving standard care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | – | Procedure: Standard physical therapyPatients will receive the standard physical therapy sessions that they would normally receive during their IRF stay, (60 to 90 min sessions, 5 to 6 days/week). This group will not receive Ekso exoskeleton gait training. |
| Ekso exoskeleton gait training group | – | Device: Ekso gait training, Procedure: Standard physical therapyPatients in the Ekso group will have several (2 to 3) of their standard of care sessions replaced with Ekso gait training sessions each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient Rehabilitation Facility
Key inclusion criteria (3 listed)
- Inpatient at Sunnyview Rehabilitation Hospital
- Right or left hemispheric stroke
- >18 years of age
Key exclusion criteria (14 listed)
- No paresis
- Paraplegia
- Quadriplegia
- FAC of 2,3 or 4
- Weight > 220 lbs (Ekso manufacturer criteria)
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 |
|---|---|---|
| Ekso gait trainingEkso sessions will be 60 minutes each. Patients will be measured to optimize Ekso fit during their initial training session. Ekso settings will be progressed as deemed appropriate by the trained clinician. The progression of Ekso settings allows the patient to use their maximum effort while the Ekso assists only as much as the patient requires to complete stepping. Patients may also spend time working on pre-gait activities and balance activities including weight shifting, stepping in place, side-stepping and backwards ambulation based on the patient's needs as determined by the clinician. | Device | Ekso exoskeleton gait training group |
| Standard physical therapyStandard physical therapy sessions will be 60 to 90 minutes a day. Clinicians typically focus on gait, balance, and strengthening activities that address goals related to functional mobility. Other devices that would normally be used during PT sessions, including the Lite Gait and Rifton tram body weight support devices and electrical stimulation devices including the XCITE and RT300 (from Restorative Therapies). | Procedure or surgery | Ekso exoskeleton gait training group, Standard of care group |
Primary outcome
10-meter walk test at self-selected speed (10MWT, SSS)
Time frame: T1 (Day 14-16)
Used to assess walking speed over a short distance at the patient's chosen speed.
10-meter walk test at self-selected speed (10MWT, SSS)
Time frame: T2 (Day 20-22)
Used to assess walking speed over a short distance at the patient's chosen speed.
10-meter walk test at self-selected speed (10MWT, SSS)
Time frame: T3 (Day 27-29)
Used to assess walking speed over a short distance at the patient's chosen speed.
10-meter walk test at fast speed (10MWT, fast)
Time frame: T1 (Day 14-16)
Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
10-meter walk test at fast speed (10MWT, fast)
Time frame: T2 (Day 20-22)
Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
10-meter walk test at fast speed (10MWT, fast)
Time frame: T3 (Day 27-29)
Used to assess walking speed over a short distance at a self-determined speed that is as fast as they can safely walk.
BERG Balance scale
Time frame: T1 (Day 14-16)
A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements.
BERG Balance scale
Time frame: T2 (Day 20-22)
A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements.
BERG Balance scale
Time frame: T3 (Day 27-29)
A 14-item scale used to assess sitting, standing, static and dynamic balance. The test focuses on the ability to maintain a position and adjust posture to complete functional movements.
6-minute walk test (6MWT)
Time frame: T1 (Day 14-16)
Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
6-minute walk test (6MWT)
Time frame: T2 (Day 20-22)
Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
6-minute walk test (6MWT)
Time frame: T3 (Day 27-29)
Used to assess walking endurance and aerobic capacity. The total distance a patient walks over six minutes is recorded.
4 secondary outcomes
Functional Ambulation Category (FAC)
Time frame: T1 (Day 14-16)
Functional Ambulation Category (FAC)
Time frame: T2 (Day 20-22)
Functional Ambulation Category (FAC)
Time frame: T3 (Day 27-29)
Intrinsic Motivation Inventory (IMI)
Time frame: T2 (Day 20-22)
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 9 Apr 2026.
- Background: PubMed 30213258Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.
- Background: PubMed 18971382Bowden MG, Balasubramanian CK, Behrman AL, Kautz SA. Validation of a speed-based classification system using quantitative measures of walking performance poststroke. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):672-5. doi: 10.1177/1545968308318837.
- Background: PubMed 30723189Goffredo M, Guanziroli E, Pournajaf S, Gaffuri M, Gasperini G, Filoni S, Baratta S, Damiani C, Franceschini M, Molteni F; Italian EksoGait Study Group. Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Eur J Phys Rehabil Med. 2019 Dec;55(6):710-721. doi: 10.23736/S1973-9087.19.05574-6. Epub 2019 Feb 4.
- Background: PubMed 31851872Kubo H, Nozoe M, Kanai M, Furuichi A, Onishi A, Kajimoto K, Mase K, Shimada S. Reference value of 6-minute walk distance in patients with sub-acute stroke. Top Stroke Rehabil. 2020 Jul;27(5):337-343. doi: 10.1080/10749357.2019.1704372. Epub 2019 Dec 18.
- Background: PubMed 17908575Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
- Background: PubMed 28118698Molteni F, Gasperini G, Gaffuri M, Colombo M, Giovanzana C, Lorenzon C, Farina N, Cannaviello G, Scarano S, Proserpio D, Liberali D, Guanziroli E. Wearable robotic exoskeleton for overground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results. Eur J Phys Rehabil Med. 2017 Oct;53(5):676-684. doi: 10.23736/S1973-9087.17.04591-9. Epub 2017 Jan 24.
- Background: PubMed 33466749Molteni F, Guanziroli E, Goffredo M, Calabro RS, Pournajaf S, Gaffuri M, Gasperini G, Filoni S, Baratta S, Galafate D, Le Pera D, Bramanti P, Franceschini M, On Behalf Of Italian Eksogait Study Group. Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects. Brain Sci. 2021 Jan 14;11(1):104. doi: 10.3390/brainsci11010104.
- Background: PubMed 29901487Moore JL, Potter K, Blankshain K, Kaplan SL, O'Dwyer LC, Sullivan JE. A Core Set of Outcome Measures for Adults With Neurologic Conditions Undergoing Rehabilitation: A CLINICAL PRACTICE GUIDELINE. J Neurol Phys Ther. 2018 Jul;42(3):174-220. doi: 10.1097/NPT.0000000000000229.
- Background: PubMed 30055163Nam YG, Lee JW, Park JW, Lee HJ, Nam KY, Park JH, Yu CS, Choi MR, Kwon BS. Effects of Electromechanical Exoskeleton-Assisted Gait Training on Walking Ability of Stroke Patients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jan;100(1):26-31. doi: 10.1016/j.apmr.2018.06.020. Epub 2018 Jul 25.
- Background: PubMed 33192438Nolan KJ, Karunakaran KK, Chervin K, Monfett MR, Bapineedu RK, Jasey NN, Oh-Park M. Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. Front Neurorobot. 2020 Oct 30;14:581815. doi: 10.3389/fnbot.2020.581815. eCollection 2020.
- Background: PubMed 32010039Rojek A, Mika A, Oleksy L, Stolarczyk A, Kielnar R. Effects of Exoskeleton Gait Training on Balance, Load Distribution, and Functional Status in Stroke: A Randomized Controlled Trial. Front Neurol. 2020 Jan 15;10:1344. doi: 10.3389/fneur.2019.01344. eCollection 2019.
- Background: PubMed 30887864Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
- Ekso Bionics - Exoskeleton deviceLink 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. This study is not recruiting at the moment.
Karah Lenge, DPT principal investigator
Sunnyview Rehabilitation Hospital
Allison Tallon, DPT principal investigator
Sunnyview Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke, Acute, run by Sunnyview Rehabilitation Hospital at 1 site 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 3 inclusion and 14 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 9 Apr 2026. 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 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?
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?
10-meter walk test at self-selected speed (10MWT, SSS) (time frame: T1 (Day 14-16)). The study lists 12 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 NCT05241457, which also lists 12 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 9 Apr 2026.