Effects of Intrinsic Foot Muscles Training in Improving Stability in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Four Square Step Test (FSST): dynamic stability assessment test.
研究概览
简要总结
The study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0
排除标准
- •Cognitive disturbances that could affect the performance of any of the tests or questionnaires included in the study
- •Diagnosis of visual or vestibular disorders that could affect patient stability
- •Change in Multiple Sclerosis-specific medication in the 2 months prior to the start of the study
- •Acute relapse in the 2 months prior to the start of the study
- •Traumatologic or orthopaedic disorders that could negatively affect balance.
研究组 & 干预措施
Control Group
干预措施: Intrinsic Mucle Training (Procedure)
Training Group
干预措施: Intrinsic Mucle Training (Procedure)
结局指标
主要结局
Four Square Step Test (FSST): dynamic stability assessment test.
时间窗: Initial and after 8 weeks
The test consists of drawing a cross on the floor, delimiting 4 squares. The subject is placed in square number 1 in front of square number 2. The objective is to enter as quickly as possible into each square following the following sequence: Square number 1, 2, 3, 4, 1, 4, 4, 3, 2 and 1. It measures time.
Six Spot Step Test (SSST): test that quantitatively assesses lower limb function
时间窗: Initial and after 8 weeks
The test field measured one meter (width) by five meters (length). In the middle of the width line (0.50 m), a cone was placed in the proximal and distal areas of the line (start point and finish point). On each lateral line, two cones were placed at distances of one and three meters on the left. Another two cones were placed at two and four meters on the right. The subjects were instructed to walk on alternating sides and to kick the cones, alternating between the medial and lateral sides of the same foot. The subjects were instructed to complete the test as quickly as possible, without running. It measures distance.
The Frailty and Injuries: Cooperative Studies of Intervention Tecnhiques (FICSIT-4 test): Test of static balance
时间窗: 0-9 points. Initial and after 8 weeks
Participants have to maintain four progressively difficult foot positions for 10 seconds each (side by side stance, semi-tandem stance, tanden stance, unipedal stance). It measures the ability to maintain posture without losing balance is evaluated.
Activities-specific Balance Confidence scale (AsBC)
时间窗: Initial and after 8 weeks
Evaluate the patient´s perceived of balance confidence during 16 different daily activities. 0%-100%
次要结局
未报告次要终点
研究者
Inés Llamas-Ramos
PhD
University of Salamanca