The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System

Stroke Clinical Trial

Official title:

The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503316
• Other study ID #: ONZ-2022-0324
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Ghent
• Contact: Anke Van Bladel, Phd
• Phone: 09 332 12 43
• Email: anke.vanbladel[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Spinal Cord Injuries
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Dynamic balance training
Participants will receive dynamic balance training while walking on the GRAIL device.
• Traditional gait rehabilitation
Participants will receive traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	Before intervention
Primary	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.	Before intervention
Primary	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.	Before intervention
Primary	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.	Within one week after the intervention
Primary	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.	Before intervention
Primary	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.	Within one week after the intervention
Primary	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.	Within one week after the intervention
Primary	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.	Within one week after the intervention
Primary	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
Primary	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
Primary	Margins of stability	Dynamic balance during walking measured during normal walking and during the balance task.	Before intervention
Primary	Margins of stability	Dynamic balance during walking measured during normal walking and during the balance task.	Within one week after the intervention
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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?	Before intervention
Secondary	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?	Within one week after the intervention
Secondary	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?	Before intervention
Secondary	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?	Within one week after the intervention
Secondary	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
Secondary	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