Early Robotic Gait Training After Stroke (ERA Stroke)

Baylor Scott and White Health (BSWH)

Status: Enrolling

Conditions: Stroke

Treatments: Device: Robotic Gait Training; Other: Usual Care Gait Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06430632

90IFRE0074 (Other Grant/Funding Number)

023-471

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-85 years of age
• All types of stroke
• Acute/subacute phase of recovery
• Medically stable as deemed by a physician
• Undergoing medical care and rehabilitation at BSWIR
• All genders, races, and ethnicities
• Meets Ekso robotic exoskeleton frame limitations
• Continence or on a program for bladder and bowel management
• Capacity and goal for walking recovery

Exclusion criteria

• Concurrent neurological diagnoses (e.g., TBI, degenerative, CNS neoplasm)
• Profound cognitive impairment
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Robotic Gait Training

Experimental group

Description:

Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.

Treatment:

Device: Robotic Gait Training

Usual Care Gait Training

Active Comparator group

Description:

Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay.

Treatment:

Other: Usual Care Gait Training