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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHasselt University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • BOOST GAIT Program

    Behavioral

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BOOST GAITExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At inclusion and the end of the intervention at 4 weeks.

Secondary outcomes

1

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.

Time frame
At inclusion and the end of the intervention at 4 weeks.
2

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.

Time frame
At inclusion and the end of the intervention at 4 weeks.
3

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.

Time frame
At inclusion and the end of the intervention at 4 weeks.
4

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.

Time frame
At inclusion and the end of the intervention at 4 weeks.

Other outcomes

Sponsors and contacts

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Hasselt University

Lead sponsor

Jessa Hospital

Collaborator