Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BOOST GAIT Program.
- Who it may be relevant to
- Registry conditions: Stroke with Hemiparesis, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Behavioral BOOST GAIT Program
In addition to usual care, participants will undergo additional therapy over a four-week period, with sessions occurring five times per week for one hour. 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.
Primary outcome measures
- Self-selected Gait Speed (m/s) [Time frame: At inclusion and the end of the intervention at 4 weeks.]
Secondary outcome measures (8)
- Fugl-Meyer assessment - motor subscale for the Lower Extremity (FM-LE) [0-34] [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Motricity Index - subscale for the Lower Extremity (MI-LE) [0-100] [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Berg Balance Scale (BBS) [0-56] [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Functional Ambulation Category (FAC) [0-5] [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Smoothness during a sit-to-stand transfer [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Postural sway during quiet standing [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Spatio-temporal parameters of the gait pattern during self-selected walking over a short distance [Time frame: At inclusion and the end of the intervention at 4 weeks.]
- Spatio-temporal parameters of the gait pattern during fastest walking over a longer distance [Time frame: At inclusion and the end of the intervention at 4 weeks.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- FRAME by Jessa Ziekenhuis — Herk-de-Stad
Identifiers
NCT: NCT06612359 · 2024/029 - BOOST GAIT pilot · B2432024000003