Early Robotic Gait Training After Stroke

NCT06430632 | Recruiting FDA Device

• 2 other identifiers: 023-47190IFRE0074
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Exoskeleton; Gait training; Inpatient rehabilitation; Physical therapy; Physical rehabilitation and medicine; Randomized controlled trial; Robotic gait training

Outcome Measures

Primary Outcomes (1)

• Gait speed via 10-Meter Walk Test (10MWT)

  The 10MWT assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline. The 10MWT can be used to categorize individuals according to their ambulatory ability: household ambulators (\<0.4 m/s), limited community ambulators (0.4 to 0.8 m/s), and community ambulators (\>0.8 m/s). Score changes \>0.16 m/s exceed the MCID. Normal gait speed for adults older than 50 years is \>1.27 m/s.

  within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation

Secondary Outcomes (11)

• Functional Ambulation Category (FAC)

  within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation

• Continuity Assessment Record and Evaluation (CARE)

  within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation

• 6-Minute Walk Test (6MWT)

  within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation

• Modified Rankin Scale (mRS)

  within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation

• Stroke Rehabilitation Assessment of Movement (STREAM)

  within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation

Other Outcomes (5)

• Gait quality

  weekly until discharge from inpatient rehabilitation (an average of 2 weeks)

• Pain following each gait training session

  weekly until discharge from inpatient rehabilitation (an average of 2 weeks)

• Adverse event rate

  through study completion (up to 3.5 months)

Study Arms (2)

Robotic Gait Training

EXPERIMENTAL

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

Device: Robotic Gait Training

Usual Care Gait Training

ACTIVE COMPARATOR

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

Other: Usual Care Gait Training

Interventions

Usual Care Gait Training 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.

Also known as: Standard of Care Gait Training

Usual Care Gait Training

Robotic Gait Training 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.

Also known as: EksoNR Robotic Exoskeleton

Robotic Gait Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39425088 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sara Baltz, MS

CONTACT

(214) 820-5022; Sara.Baltz@BSWHealth.org

Faith Meza, MPH

CONTACT

(214) 820-9409; Faith.Meza@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the experimental group receiving robotic gait training or the control group receiving usual care gait training.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)