Clinical trial NCT06430632: Early Robotic Gait Training After Stroke
Official title: Early Robotic Gait Training After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Exoskeleton
Gait training
Inpatient rehabilitation
Physical therapy
Physical rehabilitation and medicine
Randomized controlled trial
Robotic gait training
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-05-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the experimental group receiving robotic gait training or the control group receiving usual care gait training.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gait speed via 10-Meter Walk Test (10MWT)
timeFrame: 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:
measure: Functional Ambulation Category (FAC)
timeFrame: 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
measure: Continuity Assessment Record and Evaluation (CARE)
timeFrame: 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
measure: 6-Minute Walk Test (6MWT)
timeFrame: 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
measure: Modified Rankin Scale (mRS)
timeFrame: 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
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: 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
measure: 5 Times Sit-to-Stand Test (5TSST)
timeFrame: 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
measure: Berg Balance Scale (BBS)
timeFrame: 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
measure: Stroke Impact Scale - 16 (SIS-16)
timeFrame: 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
measure: Rating of Perceived Exertion (RPE)
timeFrame: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
measure: Number of steps (RGT only)
timeFrame: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
measure: Distance walked (UC only)
timeFrame: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
Other outcomes:
measure: Gait quality
timeFrame: weekly until discharge from inpatient rehabilitation (an average of 2 weeks)
measure: Pain following each gait training session
timeFrame: weekly until discharge from inpatient rehabilitation (an average of 2 weeks)
measure: Adverse event rate
timeFrame: through study completion (up to 3.5 months)
measure: Treatment tolerability (RGT only)
timeFrame: weekly until discharge from inpatient rehabilitation (an average of 2 weeks)
measure: Treatment completion rate
timeFrame: through study completion (up to 3.5 months)
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
References: