Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612359
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke - a Pilot Study Impact Van Het BOOST GAIT Programma Op Het Herstel Van Het Gangbeeld En Functionele Mobiliteit Na Een Beroerte - Een Pilootstudie
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOOST GAIT
Brief Summary:
The overarching goal is to determine if the BOOST GAIT program can improve functional mobility in patients with stroke who are undergoing inpatient rehabilitation and have some walking function through the application of augmented therapeutic exercises designed to achieve a normative gait pattern The evaluation will be conducted using a combination of clinical scales and objective motion sensors that map walking quality and performance during activities of daily living such as rising from a chair and standing
It is acknowledged that this single-group pilot study which aims to include 12 participants is insufficiently powered to address the primary objective A larger parallel-design study is required to definitively address this issue To help design a larger study the current objectives are first to have realistic expectations regarding recruitment and dropout rates second to identify potential barriers to therapy adherence and data collection that may impede the success of a larger study third assess the test-retest reliability of sensor-based motion capture of movement quality during walking and related tasks in hemiparetic stroke patients For the latter objective the sensor measurements at the end of the intervention will be repeated on two consecutive days
In addition to their usual care participants will undergo additional therapy over a four-week period with sessions occurring five times per week for one hour as part of the BOOST GAIT program The BOOST GAIT sessions will be conducted as group-based therapy with four patients and two physiotherapists present to oversee the performance of mobility-specific exercises including sit-to-stand transfers standing and stepping and eventually walking The rationale for this approach is that the combined effects of augmenting the amount of therapeutic exercises and specifically targeting motor control of the paretic leg will facilitate symmetry during tasks which in turn will have carry-over effects on safe performance of walking and other mobility tasks
It is acknowledged that this single-group pilot study which aims to include 12 participants is insufficiently powered to address the primary objective A larger parallel-design study is required to definitively address this issue To help design a larger study the current objectives are first to have realistic expectations regarding recruitment and dropout rates second to identify potential barriers to therapy adherence and data collection that may impede the success of a larger study third assess the test-retest reliability of sensor-based motion capture of movement quality during walking and related tasks in hemiparetic stroke patients For the latter objective the sensor measurements at the end of the intervention will be repeated on two consecutive days
In addition to their usual care participants will undergo additional therapy over a four-week period with sessions occurring five times per week for one hour as part of the BOOST GAIT program The BOOST GAIT sessions will be conducted as group-based therapy with four patients and two physiotherapists present to oversee the performance of mobility-specific exercises including sit-to-stand transfers standing and stepping and eventually walking The rationale for this approach is that the combined effects of augmenting the amount of therapeutic exercises and specifically targeting motor control of the paretic leg will facilitate symmetry during tasks which in turn will have carry-over effects on safe performance of walking and other mobility tasks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None