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Clinical Trials/NCT05503316
NCT05503316
Recruiting
N/A

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

University Hospital, Ghent1 site in 1 country42 target enrollmentSeptember 5, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital, Ghent
Enrollment
42
Locations
1
Primary Endpoint
Margins of stability
Status
Recruiting
Last Updated
2 years ago

Overview

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:

  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.

Registry
clinicaltrials.gov
Start Date
September 5, 2022
End Date
September 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Margins of stability

Time Frame: Within one week after the intervention

Dynamic balance during walking measured during normal walking and during the balance task.

Time in swing and stance phase (s)

Time Frame: Within one week after the intervention

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.

Cadence (steps per minute)

Time Frame: Within one week after the intervention

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.

Visual analogue scale score to assess task specific confidence

Time Frame: Within one week after the intervention

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).

Step length (m)

Time Frame: Within one week after the intervention

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

Time Frame: Within one week after the intervention

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.

Gait speed (m/s)

Time Frame: Before the intervention

Difference in gait speed between persons with high balance confidence and low balance confidence measured during walking on the treadmill.

Step width (m)

Time Frame: Within one week after the intervention

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.

Activity-specific Balance Confidence (ABC) scale

Time Frame: Within one week after the intervention

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 restraints

Time Frame: Within one week after the intervention

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 Outcomes

  • Anxiety and depression(Within one week after the intervention)
  • Scoring on a visual analogue scale to assess fear of falling(Before intervention)
  • Quality of life using the SF36_C questionnaire(Within one week after the intervention)
  • Gait quality(Within one week after the intervention)

Study Sites (1)

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