Clinical trial NCT05503316: The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
Official title: The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Traumatic Brain Injury
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2022-08-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gait speed (m/s)
timeFrame: Before the intervention
measure: Step length (m)
timeFrame: Before intervention
measure: Step width (m)
timeFrame: Before intervention
measure: Cadence (steps per minute)
timeFrame: Before intervention
measure: Cadence (steps per minute)
timeFrame: Within one week after the intervention
measure: Time in swing and stance phase (s)
timeFrame: Before intervention
measure: Time in swing and stance phase (s)
timeFrame: Within one week after the intervention
measure: Step width (m)
timeFrame: Within one week after the intervention
measure: Step length (m)
timeFrame: Within one week after the intervention
measure: 10 meter walk test
timeFrame: Before intervention
measure: 10 meter walk test
timeFrame: Within one week after the intervention
measure: Margins of stability
timeFrame: Before intervention
measure: Margins of stability
timeFrame: Within one week after the intervention
measure: Activity-specific Balance Confidence (ABC) scale
timeFrame: Before intervention
measure: Activity-specific Balance Confidence (ABC) scale
timeFrame: Within one week after the intervention
measure: Visual analogue scale score to assess task specific confidence
timeFrame: Before intervention
measure: Visual analogue scale score to assess task specific restraints
timeFrame: Before intervention
measure: Visual analogue scale score to assess task specific confidence
timeFrame: Within one week after the intervention
measure: Visual analogue scale score to assess task specific restraints
timeFrame: Within one week after the intervention
Secondary outcomes:
measure: Quality of life using the SF36_C questionnaire
timeFrame: Before intervention
measure: Quality of life using the SF36_C questionnaire
timeFrame: Within one week after the intervention
measure: Anxiety and depression
timeFrame: Before intervention
measure: Anxiety and depression
timeFrame: Within one week after the intervention
measure: Gait quality
timeFrame: Within one week after the intervention
measure: Scoring on a visual analogue scale to assess fear of falling
timeFrame: Before intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: Ghent University Hopsital / Ghent University
name: Anke Van Bladel, PhD
role: PRINCIPAL_INVESTIGATOR
References: