Clinical trial NCT05241457: Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.
Official title: Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Stroke, Acute
Cerebrovascular Accident
Cerebrovascular Accident, Acute
Keywords: Exoskeleton
Gait training
Inpatient rehabilitation
Ekso gait training
Lead sponsor: Sunnyview Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatient Rehabilitation Facility

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Inpatient at Sunnyview Rehabilitation Hospital
* Right or left hemispheric stroke
* \>18 years of age

Exclusion Criteria:

* No paresis
* Paraplegia
* Quadriplegia
* FAC of 2,3 or 4
* Weight \> 220 lbs (Ekso manufacturer criteria)
* Height \> 6'4" (Ekso manufacturer criteria)
* \> 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

Primary outcomes:
measure: 10-meter walk test at self-selected speed (10MWT, SSS)
timeFrame: T1 (Day 14-16)
measure: 10-meter walk test at self-selected speed (10MWT, SSS)
timeFrame: T2 (Day 20-22)
measure: 10-meter walk test at self-selected speed (10MWT, SSS)
timeFrame: T3 (Day 27-29)
measure: 10-meter walk test at fast speed (10MWT, fast)
timeFrame: T1 (Day 14-16)
measure: 10-meter walk test at fast speed (10MWT, fast)
timeFrame: T2 (Day 20-22)
measure: 10-meter walk test at fast speed (10MWT, fast)
timeFrame: T3 (Day 27-29)
measure: BERG Balance scale
timeFrame: T1 (Day 14-16)
measure: BERG Balance scale
timeFrame: T2 (Day 20-22)
measure: BERG Balance scale
timeFrame: T3 (Day 27-29)
measure: 6-minute walk test (6MWT)
timeFrame: T1 (Day 14-16)
measure: 6-minute walk test (6MWT)
timeFrame: T2 (Day 20-22)
measure: 6-minute walk test (6MWT)
timeFrame: T3 (Day 27-29)
Secondary outcomes:
measure: Functional Ambulation Category (FAC)
timeFrame: T1 (Day 14-16)
measure: Functional Ambulation Category (FAC)
timeFrame: T2 (Day 20-22)
measure: Functional Ambulation Category (FAC)
timeFrame: T3 (Day 27-29)
measure: Intrinsic Motivation Inventory (IMI)
timeFrame: T2 (Day 20-22)
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: Sunnyview
state: New York
Study officials:
affiliation: Sunnyview Rehabilitation Hospital
name: Karah Lenge, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnyview Rehabilitation Hospital
name: Allison Tallon, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bowden 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.
citation: Goffredo 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.
citation: Kubo 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.
citation: Mehrholz 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.
citation: Molteni 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.
citation: Molteni 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.
citation: Moore 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.
citation: Nam 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.
citation: Nolan 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.
citation: Rojek 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.
citation: Swank 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.