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NCT05241457 · ClinicalTrials.gov registry record
Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.
A clinical trial of Stroke and Cerebrovascular Accident, sponsored by Sunnyview Rehabilitation Hospital.
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT05241457 is a study of Stroke and Cerebrovascular Accident that is actively recruiting participants, run by Sunnyview Rehabilitation Hospital. The registered enrollment target is 120 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05241457, a study of Stroke and Cerebrovascular Accident, is actively recruiting participants, sponsored by Sunnyview Rehabilitation Hospital.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study 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), th
Conditions Studied
Interventions
- DEVICE Ekso gait training
- PROCEDURE Standard physical therapy
Study Locations (1)
New York
- Sunnyview - Schenectady
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2026-03 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05241457
The ClinicalTrials.gov registry entry for NCT05241457 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The listed sponsor is Sunnyview Rehabilitation Hospital, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Ekso gait training is the first listed.
NCT05241457 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05241457 about?
NCT05241457 is a clinical study titled "Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.". 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...
What is the current status of trial NCT05241457?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2022-03-11. Estimated completion is 2026-03.
What conditions does trial NCT05241457 study?
This clinical trial studies the following conditions: Stroke, Cerebrovascular Accident, Stroke, Acute, Cerebrovascular Accident, Acute.
What interventions are being tested in trial NCT05241457?
The interventions under investigation include: Ekso gait training (DEVICE), Standard physical therapy (PROCEDURE).
Who is sponsoring clinical trial NCT05241457?
This trial is sponsored by Sunnyview Rehabilitation Hospital, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05241457 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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