NCT06430632

Early Robotic Gait Training After Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR).

Detailed description

Importance: Stroke is estimated to affect 6.6 million Americans, and around 795,000 new cases are reported each year. By 2030, annual stroke-related healthcare costs are expected to eclipse $240 billion, a staggering 445% increase from the current annual cost of $53.9 billion. Specialized stroke rehabilitation reduces long-term disability and stroke-related costs, making cost-efficient efforts to minimize functional deficits faced by people with stroke (e.g., gait impairment) a high priority. This project will provision preliminary evidence regarding the clinical use and efficacy of robotic gait training (RGT) during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation. Its results will help with developing safe, tolerable, and cost-effective training protocols to improve walking function after stroke. Additionally, follow-up assessments after discharge will investigate any carryover effect of RGT, providing foundational data to evaluate the dose-response relationship for delivering RGT during inpatient rehabilitation after stroke. Altogether, this evidence will help stroke rehabilitation programs to assess their planning and budgeting needs prior to adopting RGT technology, improving outcomes and lowering lifetime care costs for patients with stroke. Aims: (1) Evaluate the safety, tolerability, and feasibility of delivering an RGT intervention that meets the unique needs of people after stroke during inpatient rehabilitation informed by an Advisory Board comprised of stakeholders living with stroke. (2) Examine the efficacy of RGT compared to usual care (UC) gait training during inpatient rehabilitation for people with stroke. (3) Conduct a cost analysis of delivering RGT during inpatient rehabilitation compared to UC. Methods: This randomized controlled trial will enroll 54 patients admitted to the Baylor Scott and White Institute for Rehabilitation following stroke. Participants will be randomized to either the experimental group receiving RGT or the control group receiving UC. Addition to State-of-the-Art: Expected products include a manualized, stakeholder-informed RGT intervention and cost-analysis template that can be replicated across early rehabilitation settings nationally for people with stroke. Sustained Approach: This project builds upon our earlier findings to achieve optimal walking recovery post-stroke during inpatient rehabilitation. The proposed work will generate preliminary efficacy, safety, tolerability, feasibility, and cost-analysis data concerning delivering an RGT intervention during the subacute phase for people with stroke.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Robotic Gait Training	Participants will complete standing and walking activities while wearing a robotic exoskeleton. Participants will also be asked to complete questionnaires about their walking and function.
OTHER	Usual Care Gait Training	Participants will complete standing and walking activities such as body weight-supported treadmill training and conventional overground walking. Participants will also be asked to complete questionnaires about their walking and function.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-28
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study