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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A first-ever unilateral stroke, infarction or bleeding

• Undergoing inpatient rehabilitation in the Jessa hospital, Herk-de-Stad

• Less than 3 months after stroke onset at the moment of inclusion

• 18 years of older

• Berg Balance Scale score 24 or higher (out of 56) at moment of inclusion

• Timed Up-and-Go score 14 s or higher at moment of inclusion

• Functional Ambulation Category 3 or higher at moment of inclusion

• Understanding the goals and procedures of this study and giving informed consent

Locations
Other Locations
Belgium
FRAME by Jessa Ziekenhuis
RECRUITING
Herk-de-stad
Contact Information
Primary
Jonas Schröder, Hasselt University, PhD
jonas.schroder@uhasselt.be
+32 473730164
Backup
Sarah Meyer, Jessa Hospital, PhD
Sarah.Meyer@jessazh.be
+32 472789592
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 12
Treatments
Experimental: BOOST GAIT
Participants recruited for this pilot study will undergo the BOOST GAIT program in addition to their usual inpatient rehabilitation care.
Related Therapeutic Areas
Sponsors
Collaborators: Jessa Hospital
Leads: Hasselt University

This content was sourced from clinicaltrials.gov