StrokeNCT05503316
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
A study testing Dynamic balance training and Traditional gait rehabilitation in people with Stroke and Spinal Cord Injuries, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries, Traumatic Brain Injury
- What is being tested?
- Dynamic balance training and Traditional gait rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Sep 2022to 1 Sep 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Anke Van Bladel, PhD, 093321243, anke.vanbladel@ugent.be
About this study
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.
Read more
Research questions:
- Do people with high confidence in their balance when walking differ from those with low confidence in their balance when walking?
- 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
- Being tested
- Dynamic balance training, Traditional gait rehabilitation
- Medical subject headings
- Stroke, Spinal Cord Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic balance trainingOther
Participants will receive dynamic balance training while walking on the GRAIL device.
Traditional gait rehabilitationOther
Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dynamic balance training |
| 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. Receives: Other: Traditional gait rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed (m/s)
Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking on the treadmill.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within one week after the intervention
Margins of stability
Dynamic balance during walking measured during normal walking and during the balance task.
Measured: Before intervention
Margins of stability
Dynamic balance during walking measured during normal walking and during the balance task.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Within one week after the intervention
Secondary outcomes (6)
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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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.
Measured: 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.
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start5 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Anke Van Bladel, PhD, Principal investigator, Ghent University Hopsital / Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503316
- Sponsor's protocol ID
- ONZ-2022-0324
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No