Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT05241457
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.
Study:
NCT05241457
Study Brief:
Protocol Section:
NCT05241457