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| Name | Class |
|---|---|
| University Ghent | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRAIL group | Experimental | 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. |
|
| Traditional gait rehabilitation | Active Comparator | Participant will receiver traditional gait rehabilitation which also includes training balance during walking. Therapy frequency in both groups is equal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic balance training | Other | Participants will receive dynamic balance training while walking on the GRAIL device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed (m/s) | Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking on the treadmill. | Before the intervention |
| Step length (m) | Step length (m)
| Before intervention |
| Step width (m) | Step width (m)
| Before intervention |
| Cadence (steps per minute) | Cadence (steps per minute)
| Before intervention |
| Cadence (steps per minute) | Cadence (steps per minute)
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life using the SF36_C questionnaire | Questionnaire to assess the quality of life (SF36_C)
| Before intervention |
| Quality of life using the SF36_C questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anke Van Bladel, Phd | Contact | 09 332 12 43 | anke.vanbladel@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Anke Van Bladel, PhD | Ghent University Hopsital / Ghent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Traditional gait rehabilitation | Other | Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device. |
|
| Within one week after the intervention |
| Time in swing and stance phase (s) | Time in swing and stance phase (s)
| Before intervention |
| Time in swing and stance phase (s) | Time in swing and stance phase (s)
| Within one week after the intervention |
| Step width (m) | step width (m)
| Within one week after the intervention |
| Step length (m) | Step length (m)
| 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. | 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. | Within one week after the intervention |
| Margins of stability | Dynamic balance during walking measured during normal walking and during the balance task. | Before intervention |
| Margins of stability | Dynamic balance during walking measured during normal walking and during the balance task. | 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. | 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. | 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. | 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. | 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). | 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. | Within one week after the intervention |
Questionnaire to assess the quality of life (SF36_C)
|
| Within one week after the intervention |
| Anxiety and depression | Hospital anxiety and depression scale (HADS)
| Before intervention |
| Anxiety and depression | Hospital anxiety and depression scale (HADS)
| 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. | 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. | Before intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |