Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke

Recruiting now · Phase 1

Conditions studied: Stroke with Hemiparesis, Stroke

In brief

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.

Key facts

Study ID

NCT06612359

Run by

Hasselt University

People needed

12

Starts

2024-09-02

Expected to finish

2024-12-31

Last updated by the study team

2024-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Significant cognitive and/or speech impairments that markedly affect the comprehension and execution of instructions

Where it is running

• FRAME by Jessa Ziekenhuis — Herk-de-Stad, Limburg, Belgium (enrolling)

Full record on ClinicalTrials.gov

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