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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Traumatic Brain Injury; Spinal Cord Injuries; Stroke

Treatments: Other: Dynamic balance training; Other: Traditional gait rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05503316

ONZ-2022-0324

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

GRAIL group

Experimental group

Description:

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.

Treatment:

Other: Dynamic balance training

Traditional gait rehabilitation

Active Comparator group

Description:

Participant will receiver traditional gait rehabilitation which also includes training balance during walking. Therapy frequency in both groups is equal.

Treatment:

Other: Traditional gait rehabilitation