Effect of Neuroproprioceptive "Facilitation, Inhibition" Physical Therapy Using Virtual Reality on Upper Limb Mobility and Postural Stability in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Nine Hole Peg Test (9HPT) - change pre/post intervention
研究概览
简要总结
The randomized controlled trial is aimed to study the efficacy of virtual reality (VR) and its impact on upper limb function and postural stability in people with mild to severe multiple sclerosis (pwMS). The conceptual idea is to compare two kinds of neuroproprioceptive "facilitation and inhibition" physical therapy, first in a real environment and second in virtual reality, in out-patient therapy that will be held in 15 hourly therapies, 2x a week in a period of two months. The efficacy will be assessed by a blinded independent clinical examiner using clinical examination and questionnaire survey before and in a week following the therapeutic intervention. The main focus is on upper limb gross and fine motor skills, trunk stability and stability, and sit to stand stability.
详细描述
In 60 - 75% of people with multiple sclerosis (MS) an upper limb mobility dysfunction (unilateral or bilateral manual dexterity, sensibility impairment, tremor) is present, resulting in reduced participation in activities of daily living.
Physiotherapy has a crucial impact on upper limb mobility, although there are many approaches applied (exercise/strengthening exercise, endurance training, sensory training, constraint-induced movement therapy, robotic rehabilitation therapy, etc.).
Virtual reality is an innovative technological concept using game mechanisms that facilitate concentration and motivation in task performance. Current research implies that VR is a safe and effective method in gait and balance//stability rehabilitation therapy and with less evidence, for upper limb mobility improvement. It is expected that a greater therapeutic effect is a result of multifactorial sense stimulation and dopamine centres in the brain.
A pilot project showed that virtual reality without the prompt feedback of a physiotherapist is not more effective than standard therapy. A new therapeutic software using virtual reality spontaneously motivating the patient for movement realization was developed in cooperation with the Department of informatics and computer science Faculty of applied sciences University West Bohemia. Accurate execution of neuroproprioceptive "facilitation and inhibition techniques" physical therapy combining key principles from proprioceptive neuromuscular stabilization (PNS) and motor program activating therapy (MPAT), ensures a present physiotherapist. These principles have shown the effect in therapy in pwMS. Participants will be randomized into two arms of the study, both implementing neuroproprioceptive "facilitation and inhibition" physical therapy, first in a real environment and second in VR.
The investigators expect that VR intervention shall improve upper limb motor functions, trunk muscles coordination, improve the performance of activities of daily living and quality of life in pwMS more than identical therapy not using VR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
All participants of the study will undergo a clinical examination including a questionnaire survey, led by a blinded independent examiner, who will not have access to intervention documentation. The examiner will see each patient twice, before the first intervention and in follow-up examination in a week following the last therapy. The examiner will be prohibited to talk about the therapy attended. The patients will be informed about the character of the examination and the importance of the most objectivity possible. All therapists can apply both interventions, therefore masking is more efficient.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria comprise of a definite diagnosis of multiple sclerosis, EDSS score ≥ 2 a ≤ 7 ((10); determined by neurologist), no history of relapse, no history of change in disease-modifying treatment, no history of corticosteroid therapy in the past three months prior to recruitment.
排除标准
- •The exclusion criteria include other factors influencing mobility (history of stroke, pregnancy, traumatic injury of limb/s. Severe cardiovascular or orthopedic dysfunction, impaired cognitive functions in the course of examination and/or consecutive therapy.
结局指标
主要结局
Nine Hole Peg Test (9HPT) - change pre/post intervention
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
The NHPT requires participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible. Lower number (quicker time) means better result.
Box and Block Test (BNB) - change pre/post intervention
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
The Box and Block Test tests gross manual dexterity. This test consists of moving, one by one, the maximum number of blocks from one compartment of a box to another of equal size, originally, within 60 seconds. A lower number (quicker time) means better result.
Hand Grip Strength (HGS) -change pre/post intervention
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
Jamar Hydraulic Hand Dynamometer measures isometric grip force and strength. The higher value, the better function (higher strength).
Tremor; Frequency for which the smoothed power spectral density is maximal (fMAX)
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - lower value, lower tremor.
Tremor; Power of the signal in band from f1 to f2 (Pf1-f2)
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
The spectral characteristic of postural tremor measured by the 3-axis accelerometer and 3-axis gyroscope chip (Motion Tracking sensor MPU-6050) - lower value, lower tremor.
Five times Sit to Stand test (5STS) -change pre/post intervention
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure)
The test assesses time when people stand and sit repeatedly five times. The lower the time to complete the test the better the outcome of the test.
次要结局
- Multiple Sclerosis Impact Scale (MSIS-29) - change pre/post intervention(Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure))
- EQ-5D-3L-health questionnaire - change pre/post intervention(Pre-assessment (baseline testing), Post-assessment (immediately in a week following the last procedure))
研究者
Kamila Řasová
assoc. prof. PhDr.Kamila Řasová, Ph.D.
Charles University, Czech Republic