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

NCT06612359 | Recruiting Phase 1

• 2 other identifiers: 2024/029 - BOOST GAIT pilotB2432024000003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Recovery; Gait; Physical exercise; Pilot study; Stroke; Hemiparesis; Walking

Outcome Measures

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.

  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]

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

• Motricity Index - subscale for the Lower Extremity (MI-LE) [0-100]

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

• Berg Balance Scale (BBS) [0-56]

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

• Functional Ambulation Category (FAC) [0-5]

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

• Smoothness during a sit-to-stand transfer

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

Study Arms (1)

BOOST GAIT

EXPERIMENTAL

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

Behavioral: BOOST GAIT Program

Interventions

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.

BOOST GAIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A first-ever unilateral stroke, infarction or bleeding
• Undergoing inpatient rehabilitation in the Jessa hospital, Herk-de-Stad
• years of older
• Understanding the goals and procedures of this study and giving informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

FRAME by Jessa Ziekenhuis

Herk-de-Stad, Limburg, 3540, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Feys, Professor

  Hasselt University, REVAL Rehabilitation Research center

  PRINCIPAL INVESTIGATOR

• Maaiken Vander Plaetse, MD

  FRAME, Jessa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Schröder, Hasselt University, PhD

CONTACT

+32 473730164; jonas.schroder@uhasselt.be

Sarah Meyer, Jessa Hospital, PhD

CONTACT

+32 472789592; Sarah.Meyer@jessazh.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Rehabilitation Sciences

Model Details: Pilot study

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 25, 2024
• Study Start: September 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)