The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System

NCT ID: NCT05503316

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-09-01

Brief Summary

Persons with an injury of the central nervous system clearly experience motor impairments. Among the most commonly described consequences are gait abnormalities and impaired balance. Although these are undeniably linked, they are also influenced by other factors. A recent systematic review (Xie, 2022) reports impaired balance, the presence of depression or anxiety, and decreased function of the lower limbs as important risk factors for fear of falling in persons after a stroke. Also for people with a spinal cord injury, the fear of falling has a major impact on their level of participation and quality of life (Sing, 2021). Preventing falls and reducing fear of falling is an important part of neurological rehabilitation programs as it is known that fear of falling has a negative impact on the patient's activity level. This in turn will lead to an increased risk of falling and a negative effect on neurological recovery due to insufficiently practicing their balance while walking.

Since 2019 the rehabilitation center of UZ gent offers GRAIL training. This device aims to train walking balance and gait adaptability in a virtual environment. Patients who are admitted and/or undergoing ambulatory rehabilitation at UZ Gent are given the opportunity to complete a 5-week training schedule on the GRAIL. Before and after this training intervention period, the investigators evaluate the gait pattern of these patients. After the training period, the patients also complete a questionnaire about their experience while training on the GRAIL and often also indicate that they become more confident in their own balance when walking. That is why the researchers now also want to measure this.

Research questions:

1. Do people with high confidence in their balance when walking differ from those with low confidence in their balance when walking?

2. Does GRAIL training have a different effect on confidence in balance than traditional rehabilitation? To answer the 2nd research question, patients who follow the traditional rehabilitation (control group) also receive the same tests as the people who follow GRAIL training.

Randomization (prepared in advance via a computer program) determines who will follow the GRAIL training and who will follow the traditional rehabilitation.

Conditions

Stroke; Spinal Cord Injuries; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GRAIL group

Participants will receive 5 weeks of training on the GRAIL device, which is focused on training balance during walking.

Therapy frequency: 2*30 minutes per week.

Group Type: EXPERIMENTAL

Dynamic balance training

Intervention Type: OTHER

Participants will receive dynamic balance training while walking on the GRAIL device.

Traditional gait rehabilitation

Participant will receiver traditional gait rehabilitation which also includes training balance during walking.

Therapy frequency in both groups is equal.

Group Type: ACTIVE_COMPARATOR

Traditional gait rehabilitation

Intervention Type: OTHER

Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.

Interventions

Dynamic balance training

Participants will receive dynamic balance training while walking on the GRAIL device.

Intervention Type: OTHER

Traditional gait rehabilitation

Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Persons who are admitted to the rehabilitation center of the Ghent University Hospital (in and outpatient) and suffered a stroke, spinal cord injury of traumatic brain injury
• Persons have to be able to walk for at least 6 minutes without the need of a person to help and with minimal help of a walking device. (level FAC 2 or higher)
• Participants who understand orders during the assessment and intervention.

Exclusion Criteria

• Other neurological conditions (MS, Parkinson, ...)
• Orthopedic trauma or recent acute trauma that influence walking ability.
• Body weight exceeds 120 kg.
• Severe dizziness that makes it impossible to practice in standing position.
• Cardiac or pulmonary problems that require monitoring during exercising.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anke Van Bladel, PhD

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hopsital / Ghent University

Locations

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Anke Van Bladel, Phd

Role: CONTACT

anke.vanbladel@ugent.be

09 332 12 43

Facility Contacts

Anke Van Bladel, PhD

Role: primary

anke.vanbladel@ugent.be

093321243

Other Identifiers

ONZ-2022-0324

Identifier Type: -

Identifier Source: org_study_id