NCT06612359 Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke
| NCT ID | NCT06612359 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hasselt University |
| Condition | Stroke with Hemiparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-09-02 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Peter Feys, Professor
PRINCIPAL INVESTIGATOR
Hasselt University, REVAL Rehabilitation Research center
Frequently Asked Questions
Who can join the NCT06612359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke with Hemiparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06612359 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06612359 currently recruiting?
Yes, NCT06612359 is actively recruiting participants. Contact the research team at jonas.schroder@uhasselt.be for enrollment information.
Where is the NCT06612359 trial being conducted?
This trial is being conducted at Herk-de-Stad, Belgium.
Who is sponsoring the NCT06612359 clinical trial?
NCT06612359 is sponsored by Hasselt University. The principal investigator is Peter Feys, Professor at Hasselt University, REVAL Rehabilitation Research center. The trial plans to enroll 12 participants.
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