Early Robotic Gait Training After Stroke

NCT ID: NCT06430632

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic Gait Training

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

Group Type: EXPERIMENTAL

Robotic Gait Training

Intervention Type: DEVICE

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.

Usual Care Gait Training

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

Group Type: ACTIVE_COMPARATOR

Usual Care Gait Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

EksoNR Robotic Exoskeleton; Standard of Care Gait Training

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara Baltz, MS

Role: CONTACT

Sara.Baltz@BSWHealth.org

(214) 820-5022

Faith Meza, MPH

Role: CONTACT

Faith.Meza@BSWHealth.org

(214) 820-9409

Facility Contacts

Baylor Scott & White Institute for Rehabilitation

Role: primary

References

da Silva Areas FZ, Baltz S, Gillespie J, Ochoa C, Gilliland T, Dubiel R, Bennett M, Driver S, Swank C. Early robotic gait training after stroke (ERA Stroke): study protocol for a randomized clinical trial. BMC Neurol. 2024 Oct 18;24(1):401. doi: 10.1186/s12883-024-03858-y.

Reference Type: DERIVED

PMID: 39425088 (View on PubMed)

Other Identifiers

90IFRE0074

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

023-471

Identifier Type: -

Identifier Source: org_study_id