The Agreement Between Face-to-Face and Tele-Assessment of Balance Tests in Patient With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Berg Balance Test
研究概览
简要总结
MS is characterized by clinical symptoms caused by lesions of the brain, spinal cord, or optic nerves that can affect balance, gait, and risk of falls. 50-80% of patients with MS have different levels of balance-related pathological findings. In addition, the imbalance is one of the most complained about findings by MS patients.
Balance and postural control disorders are the most common signs in patients with cerebellar tract damage. Many patients have reported problems with balance and gait causing serious disability. Therefore, disorders of balance and postural control in patients with MS are associated with difficulty in standing and performing functional activities. Effective quantitative methods are needed to assess postural imbalance to help clinicians assess the progression of this disorder.
Current literature suggests that home tele-rehabilitation and tele-medicine practices may be an alternative method effective enough to be equivalent to face-to-face physiotherapy treatments for patients with Ms. The advantages of Tele-medicine over normal care include increased social support, participant engagement, quality of care, cost-effectiveness, access to services (due to lack of transportation), and reducing the burden on healthcare professionals to make services easier to deploy. In cases such as Pandemic conditions, where face-to-face service is disrupted in clinics, tele-rehabilitation can be applied as a suitable alternative treatment method accessible to patients. The effectiveness of Tele-rehabilitation raises the question of whether tele-evaluation is as effective and accurate as in the clinic. Studies examining the effectiveness of Tele-assesment are still insufficient. The study is planned to address this deficiency.
The aim of this study is to compare the results of MS patients by applying valid and reliable methods used in balance assessment with face-to-face and online access methods, thereby investigating the effectiveness of balance assessment through online access.
The hypothesis in this study is that the results of the balance assessment with online access in MS patients will be consistent with the results of the balance assessment conducted face-to-face.
H0: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients.
H1: Tele-assessments of balance do not give the same results as face-to-face balance assessments in MS patients.
详细描述
Voluntary patients who have been diagnosed with MS will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Tele-assessment will be applied to one group first, and face-to-face assessment will be applied to the other group first.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years
- •Patients diagnosed with MS according to McDonald diagnostic criteria with an EDSS score of 0-6
- •Internet presence in the environment where they will perform the evaluation
- •Having an internet-based technological tool or having access to this tool
- •Having someone to accompany the patient during the evaluation
- •Agree to participate in the study
- •Ability to understand and speak Turkish
排除标准
- •Having had a new attack in the last 3 months
- •Use high-dose corticosteroid therapy in the last 2 weeks
- •Presence of orthopedic problems/problems that can cause balance problems
- •Having cognitive disorders that will prevent him from communicating
- •Having a level of visual and auditory problems that will prevent communication
结局指标
主要结局
Berg Balance Test
时间窗: change from baseline at 3rd day
It is a scale containing 14 instructions and a score of 0-4 is given by observing the patient's performance for each instruction. 0 points are given in cases where the patient cannot perform the activity at all, while 4 points are given when the patient completes the activity independently. The highest score is 56 and 0-20 points indicate balance disorder, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance. It takes between 10 and 20 minutes to complete the scale.
Dynamic Gait Index
时间窗: change from baseline at 3rd day
The scale measures mobility function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, turning, walking over objects, walking around objects, and climbing up stairs. The performance is rated on a 4-point scale.
Timed Up and Go Test
时间窗: change from baseline at 3rd day
The test is a measure of dynamic balance. It requires individuals to get up from a chair, walk 3 feet, turn and sit. The time from the moment the individual lifts the pelvis from the chair until he or she returns with the pelvis in the chair is recorded in seconds.
次要结局
未报告次要终点
研究者
Ayse Zengin Alpozgen
Asst. Prof.
Istanbul University - Cerrahpasa (IUC)