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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Traumatic Brain Injury; Spinal Cord Injuries
• Intervention / Treatment: Other: Dynamic balance training; Other: Traditional gait rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anke Van Bladel, Phd; Phone Number: 09 332 12 43; Email: anke.vanbladel@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Anke Van Bladel, PhD; Phone Number: 093321243; Email: Anke.VanBladel@UGent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRAIL group; 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; Participants will receive dynamic balance training while walking on the GRAIL device.
Active Comparator: Traditional gait rehabilitation; 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 traditional gait rehabilitation that also includes balance training while walking but not on the GRAIL device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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); 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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Anke Van Bladel, PhD, Ghent University Hopsital / Ghent University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries
• Other Study ID Numbers: ONZ-2022-0324

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No