The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Margins of stability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Margins of stability
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)