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

NCT ID: NCT06612359

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-02
• Study Completion Date: 2024-12-31

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.

Conditions

Stroke with Hemiparesis; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BOOST GAIT

Participants recruited for this pilot study will undergo the BOOST GAIT program in addition to their usual inpatient rehabilitation care.

Group Type: EXPERIMENTAL

BOOST GAIT Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Peter Feys

Professor Rehabilitation Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Feys, Professor

Role: PRINCIPAL_INVESTIGATOR

Hasselt University, REVAL Rehabilitation Research center

Maaiken Vander Plaetse, MD

Role: PRINCIPAL_INVESTIGATOR

FRAME, Jessa Hospital

Locations

FRAME by Jessa Ziekenhuis

Herk-de-Stad, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jonas Schröder, Hasselt University, PhD

Role: CONTACT

jonas.schroder@uhasselt.be

+32 473730164

Sarah Meyer, Jessa Hospital, PhD

Role: CONTACT

Sarah.Meyer@jessazh.be

+32 472789592

Facility Contacts

Sarah Meyer, PhD

Role: primary

Sarah.Meyer@jessazh.be

+32 472789592

Elvi Lemmens

Role: backup

elvi.lemmens@jessazh.be

Maaiken Vander Plaetse, MD

Role: backup

Other Identifiers

B2432024000003

Identifier Type: OTHER

Identifier Source: secondary_id

2024/029 - BOOST GAIT pilot

Identifier Type: -

Identifier Source: org_study_id