An interventional study of Dynamic balance training and Traditional gait rehabilitation in Stroke, Spinal Cord Injuries and Traumatic Brain Injury, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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:
Randomization (prepared in advance via a computer program) determines who will follow the GRAIL training and who will follow the traditional rehabilitation.
2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.
This study's planned enrollment of 42 is below the median of 48 across 1,332 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Dynamic balance training
Participant will receiver traditional gait rehabilitation which also includes training balance during walking. Therapy frequency in both groups is equal.
Other: Traditional gait rehabilitation
Participants will receive dynamic balance training while walking on the GRAIL device.
Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.
Gait speed (m/s)
Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking on the treadmill.
Time frame: Before the intervention
Step length (m)
Step length (m) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Before intervention
Step width (m)
Step width (m) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Before intervention
Cadence (steps per minute)
Cadence (steps per minute) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Before intervention
Cadence (steps per minute)
Cadence (steps per minute) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Within one week after the intervention
Time in swing and stance phase (s)
Time in swing and stance phase (s) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Before intervention
Time in swing and stance phase (s)
Time in swing and stance phase (s) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Within one week after the intervention
Step width (m)
step width (m) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Within one week after the intervention
Step length (m)
Step length (m) * Difference in spatiotemporal parameters between persons with high balance confidence and persons with low balance confidence (measured before intervention). * Difference in spatiotemporal parameters during normal walking and during a balance task during walking (measured before and after intervention period) * Difference in spatiotemporal parameters during normal walking before and after intervention.
Time frame: Within one week after the intervention
10 meter walk test
Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking overground. Change in overground walking speed before and after intervention.
Time frame: Before intervention
10 meter walk test
Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking overground. Change in overground walking speed before and after intervention.
Time frame: Within one week after the intervention
Margins of stability
Dynamic balance during walking measured during normal walking and during the balance task.
Time frame: Before intervention
Margins of stability
Dynamic balance during walking measured during normal walking and during the balance task.
Time frame: Within one week after the intervention
Activity-specific Balance Confidence (ABC) scale
Balance confidence scored by the participant (questionnaire) per item (16 items) geeft participant weer hoeveel vertrouwen hij heeft in dit item (0-100%) Hogere score is meer vertrouwen.
Time frame: Before intervention
Activity-specific Balance Confidence (ABC) scale
Balance confidence scored by the participant (questionnaire) per item (16 items) geeft participant weer hoeveel vertrouwen hij heeft in dit item (0-100%) Hogere score is meer vertrouwen.
Time frame: Within one week after the intervention
Visual analogue scale score to assess task specific confidence
Participants are asked to score the level of confidence that they have that they can complete the balance task (score 0-10). Higher score is more confidence.
Time frame: Before intervention
Visual analogue scale score to assess task specific restraints
Participants are asked to score the level of restraint that they have to complete the balance task due to fear of falling (score 0-10). Higher score is more restraint.
Time frame: Before intervention
Visual analogue scale score to assess task specific confidence
Participants are asked to score the level of confidence that they have that they can complete the balance task (score 0-10). Higher score is more confidence.Participants are asked to score the level of restraint that they have to complete the balance task due to fear of falling (score 0-10).
Time frame: Within one week after the intervention
Visual analogue scale score to assess task specific restraints
Participants are asked to score the level of restraint that they have to complete the balance task due to fear of falling (score 0-10). Higher score is more restraint.
Time frame: Within one week after the intervention
Quality of life using the SF36_C questionnaire
Questionnaire to assess the quality of life (SF36_C) * Do persons with high balance confidence have better quality of life? * Does the quality of life change after the intervention?
Time frame: Before intervention
Quality of life using the SF36_C questionnaire
Questionnaire to assess the quality of life (SF36_C) * Do persons with high balance confidence have better quality of life? * Does the quality of life change after the intervention?
Time frame: Within one week after the intervention
Anxiety and depression
Hospital anxiety and depression scale (HADS) * Do persons with high balance confidence have less anxiety and depression? * Does the anxiety and depression change after the intervention?
Time frame: Before intervention
Anxiety and depression
Hospital anxiety and depression scale (HADS) * Do persons with high balance confidence have less anxiety and depression? * Does the anxiety and depression change after the intervention?
Time frame: Within one week after the intervention
Gait quality
Joint angles of lower limbs and trunk (degree) Do persons with high balance confidence walk different than persons with low balance confidence.
Time frame: Within one week after the intervention
Scoring on a visual analogue scale to assess fear of falling
Visual analogue scale (0-10) to indicate fear of falling during walking overground in the rehabilitation center and during walking on the treadmill. Higher score is more fear to fall.
Time frame: Before intervention
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University Hospital, Ghent