Stroke with HemiparesisPhase 1BOOST GAITNCT06612359
Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke
A Phase 1 study testing BOOST GAIT Program in people with Stroke with Hemiparesis and Stroke, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke with Hemiparesis, Stroke
- What is being tested?
- BOOST GAIT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Sep 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant cognitive and/or speech impairments that markedly affect the comprehension and execution of instructions
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
FRAME by Jessa Ziekenhuis
Herk-de-Stad, Limburg, 3540
Sarah Meyer, PhD, +32 472789592, Sarah.Meyer@jessazh.be
Elvi Lemmens, elvi.lemmens@jessazh.be
About this study
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
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.
- Conditions
- Stroke with Hemiparesis, Stroke
- Being tested
- BOOST GAIT Program
- Keywords
- Recovery, Gait, Physical exercise, Pilot study, Stroke, Hemiparesis, Walking
- Medical subject headings
- Stroke, Motor Activity, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOOST GAIT ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BOOST GAIT | Experimental | Participants recruited for this pilot study will undergo the BOOST GAIT program in addition to their usual inpatient rehabilitation care. Receives: Behavioral: BOOST GAIT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-selected Gait Speed (m/s)
The 10-meter walk test (10m-WT) is used as a performance measure to assess gait speed in meters per second over a short distance. We follow a standardized protocol with 3 immediate test-retest repetitions while the participant is instructed to walk safely at a comfortable pace.
Measured: At inclusion and the end of the intervention at 4 weeks.
Secondary outcomes (8)
Fugl-Meyer assessment - motor subscale for the Lower Extremity (FM-LE) [0-34]
The FM-LE is a stroke-specific impairment measure that assesses the ability to produce voluntary movement control outside of synergistic patterns. A score of 0 indicates a completely flaccid, paralyzed limb, whereas a score of 34 reflects full motor function with synergy-independent movement. A higher score therefore reflects a better outcome.
Measured: At inclusion and the end of the intervention at 4 weeks.
Motricity Index - subscale for the Lower Extremity (MI-LE) [0-100]
The MI-LE is an impairment measure that assesses the ability to produce maximum muscle force in the direction of hip flexion, knee extension, and ankle dorsiflexion. Each item is with a score of 0 indicating a paralyzed limb and a score of 33 reflecting normal strength against manual resistance. The maximum score of 99 is set to 100 to give an index score in % of the degree of strength impairment. A higher score therefore reflects a better outcome.
Measured: At inclusion and the end of the intervention at 4 weeks.
Berg Balance Scale (BBS) [0-56]
The BBS is used to rate the ability to safely balance during 14 predetermined tasks. Each task is evaluated on a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. A higher score therefore reflects a better outcome.
Measured: At inclusion and the end of the intervention at 4 weeks.
Functional Ambulation Category (FAC) [0-5]
The FAC is a 6-point scale determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. A score of 0 means total disability, whereas a maximum score of 5 mean full independent walking over uneven terrains. A higher score therefore reflects a better outcome.
Measured: At inclusion and the end of the intervention at 4 weeks.
Smoothness during a sit-to-stand transfer
A wearable sensor system (APDM, Opal sensors) will be used to measure quality indicators of smoothness of a sit-to-stand transition. For this purpose, sensors will be attached to the body while recording kinematic data during standing-up from a chair of standardized height without using the arms. The participant is instructed to do this as fast as possible. Shorter and smoother motion mean a better outcome.
Measured: At inclusion and the end of the intervention at 4 weeks.
Postural sway during quiet standing
A wearable sensor system (APDM, Opal sensors) will be used to measure the amount of body sway during a quiet stance task. For this purpose, sensors will be attached to the body while kinematic data will be measured during standing with the feet placed at shoulder width. The participant is instructed to remain as still as possible. Reduced levels of sway mean a better outcome.
Measured: 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
A wearable sensor system (APDM, Opal sensors) will be used to measure spatio-temporal aspects of the gait pattern, with particular interest in estimates of interlimb symmetry, over a short distance. For this purpose, the sensors are attached to the body to record the motion kinematics during a straight, unobstructed walk. The participant is instructed to walk at comfortable pace for 30 seconds. Longer, faster and more consistent steps (ie, less variability), with more symmetry between the legs, mean a better outcome.
Measured: 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
A wearable sensor system (APDM, Opal sensors) will be used to measure spatio-temporal aspects of the gait pattern, with particular interest in estimates of interlimb symmetry, over a longer distance. For this purpose, the sensors are attached to the body to record the motion kinematics during a straight, unobstructed walk. The participant is instructed to walk as fast as possible, continuously for 3 minutes. Longer, faster, more consistent and symmetric steps, without decrement over the 3-min period as reflections of fatigue, mean a better outcome.
Measured: At inclusion and the end of the intervention at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start2 Sep 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke with HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, Professor, Principal investigator, Hasselt University, REVAL Rehabilitation Research centerMaaiken Vander Plaetse, MD, Principal investigator, FRAME, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612359
- Sponsor's protocol ID
- 2024/029 - BOOST GAIT pilot
- Other IDs
- B2432024000003
- Acronym
- BOOST GAIT
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06612359
- Acronym / sponsor ID
- BOOST GAIT / 2024/029 - BOOST GAIT pilot
- Conditions
- Stroke with Hemiparesis, Stroke
- Keywords
- Recovery, Gait, Physical exercise, Pilot study, Stroke, Hemiparesis, Walking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| BOOST GAIT | Experimental | Behavioral: BOOST GAIT ProgramParticipants recruited for this pilot study will undergo the BOOST GAIT program in addition to their usual inpatient rehabilitation care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Significant cognitive and/or speech impairments that markedly affect the comprehension and execution of instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOOST GAIT ProgramIn 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. | Behavioural | BOOST GAIT |
Primary outcome
Self-selected Gait Speed (m/s)
Time frame: At inclusion and the end of the intervention at 4 weeks.
The 10-meter walk test (10m-WT) is used as a performance measure to assess gait speed in meters per second over a short distance. We follow a standardized protocol with 3 immediate test-retest repetitions while the participant is instructed to walk safely at a comfortable pace.
8 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke with Hemiparesis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
RecruitingObservational study
Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
Stroke, Hemiparesis
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, Professor principal investigator
Hasselt University, REVAL Rehabilitation Research center
Maaiken Vander Plaetse, MD principal investigator
FRAME, Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BOOST GAIT Program in people with Stroke with Hemiparesis and Stroke, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Schröder, Hasselt University, PhD (+32 473730164, jonas.schroder@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-selected Gait Speed (m/s) (time frame: At inclusion and the end of the intervention at 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.