Clinical trial NCT06612359: Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Stroke with Hemiparesis
Stroke
Keywords: Recovery
Gait
Physical exercise
Pilot study
Stroke
Hemiparesis
Walking
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2024-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Self-selected Gait Speed (m/s)
timeFrame: At inclusion and the end of the intervention at 4 weeks.
Secondary outcomes:
measure: Fugl-Meyer assessment - motor subscale for the Lower Extremity (FM-LE) [0-34]
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Motricity Index - subscale for the Lower Extremity (MI-LE) [0-100]
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Berg Balance Scale (BBS) [0-56]
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Functional Ambulation Category (FAC) [0-5]
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Smoothness during a sit-to-stand transfer
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Postural sway during quiet standing
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Spatio-temporal parameters of the gait pattern during self-selected walking over a short distance
timeFrame: At inclusion and the end of the intervention at 4 weeks.
measure: Spatio-temporal parameters of the gait pattern during fastest walking over a longer distance
timeFrame: At inclusion and the end of the intervention at 4 weeks.
Other outcomes:
Locations:
city: Herk-de-Stad
country: Belgium
facility: FRAME by Jessa Ziekenhuis
state: Limburg
Study officials:
affiliation: Hasselt University, REVAL Rehabilitation Research center
name: Peter Feys, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: FRAME, Jessa Hospital
name: Maaiken Vander Plaetse, MD
role: PRINCIPAL_INVESTIGATOR
References: