Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430632
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-09
Brief Title:
Early Robotic Gait Training After Stroke
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Early Robotic Gait Training After Stroke
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERA Stroke
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 66 million Americans and around 795000 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 539 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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90IFRE0074 | OTHER_GRANT | National Institute on Disability Independent Living and Rehabilitation Research | None |