The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
Primary Purpose
Stroke, Spinal Cord Injuries, Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dynamic balance training
Traditional gait rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
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.
Sites / Locations
- Ghent University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GRAIL group
Traditional gait rehabilitation
Arm 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.
Participant will receiver traditional gait rehabilitation which also includes training balance during walking. Therapy frequency in both groups is equal.
Outcomes
Primary Outcome Measures
Gait speed (m/s)
Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking on the treadmill.
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.
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.
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.
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 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 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.
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.
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.
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.
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.
Margins of stability
Dynamic balance during walking measured during normal walking and during the balance task.
Margins of stability
Dynamic balance during walking measured during normal walking and during the balance task.
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.
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.
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.
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.
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).
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.
Secondary Outcome Measures
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?
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?
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?
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?
Gait quality
Joint angles of lower limbs and trunk (degree) Do persons with high balance confidence walk different than persons with low balance confidence.
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.
Full Information
NCT ID
NCT05503316
First Posted
August 4, 2022
Last Updated
September 12, 2023
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05503316
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injuries, Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GRAIL group
Arm Type
Experimental
Arm 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.
Arm Title
Traditional gait rehabilitation
Arm Type
Active Comparator
Arm Description
Participant will receiver traditional gait rehabilitation which also includes training balance during walking.
Therapy frequency in both groups is equal.
Intervention Type
Other
Intervention Name(s)
Dynamic balance training
Intervention Description
Participants will receive dynamic balance training while walking on the GRAIL device.
Intervention Type
Other
Intervention Name(s)
Traditional gait rehabilitation
Intervention Description
Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.
Primary Outcome Measure Information:
Title
Gait speed (m/s)
Description
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
Title
Step length (m)
Description
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
Title
Step width (m)
Description
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
Title
Cadence (steps per minute)
Description
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
Title
Cadence (steps per minute)
Description
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
Title
Time in swing and stance phase (s)
Description
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
Title
Time in swing and stance phase (s)
Description
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
Title
Step width (m)
Description
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
Title
Step length (m)
Description
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
Title
10 meter walk test
Description
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
Title
10 meter walk test
Description
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
Title
Margins of stability
Description
Dynamic balance during walking measured during normal walking and during the balance task.
Time Frame
Before intervention
Title
Margins of stability
Description
Dynamic balance during walking measured during normal walking and during the balance task.
Time Frame
Within one week after the intervention
Title
Activity-specific Balance Confidence (ABC) scale
Description
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
Title
Activity-specific Balance Confidence (ABC) scale
Description
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
Title
Visual analogue scale score to assess task specific confidence
Description
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
Title
Visual analogue scale score to assess task specific restraints
Description
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
Title
Visual analogue scale score to assess task specific confidence
Description
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
Title
Visual analogue scale score to assess task specific restraints
Description
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
Secondary Outcome Measure Information:
Title
Quality of life using the SF36_C questionnaire
Description
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
Title
Quality of life using the SF36_C questionnaire
Description
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
Title
Anxiety and depression
Description
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
Title
Anxiety and depression
Description
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
Title
Gait quality
Description
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
Title
Scoring on a visual analogue scale to assess fear of falling
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Van Bladel, Phd
Phone
09 332 12 43
Email
anke.vanbladel@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Van Bladel, PhD
Organizational Affiliation
Ghent University Hopsital / Ghent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Van Bladel, PhD
Phone
093321243
Email
anke.vanbladel@ugent.be
12. IPD Sharing Statement
Learn more about this trial
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
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