Walking-related Fatigability in Persons With Multiple Sclerosis: Psychometric Properties of Cognitive and Coordination Fatigability Assessment & Proof-of-concept of a Rehabilitation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- the symbol digit modality test (SDMT)
研究概览
简要总结
Walking impairments occur in 93% of persons with MS (pwMS) within 10 years of diagnosis. Besides the impact of muscle weakness or hypertonia, one is increasingly aware about the symptom of fatigability. Motor and cognitive fatigability is a change in performance over time depending on the tasks and circumstances. It was shown that up to half of disabled pwMS slow down during walking, impacting on real life mobility. Walking function is related to functional muscle strength, balance and centrally mediated coordination deficits but also cognitive function. Preliminary data conducted by our research group has shown that people with MS with walking fatigability had a significant decrease in movement amplitude during a bipedal coordination task in sitting position. However, the psychometric properties such as within-session and test-retest reliability of bipedal function has not yet been determined. In addition, so far, no interventional research has included exclusively people with MS with walking-related fatigability. It is unknown if the downward curve in walking speed and coordination can be reversed by multi-model interventions.
The study will have two parts (A and B). Part A investigates psychometric properties of outcome measures related to fatigability in healthy controls, persons with MS with and without fatigability during walking. Part B is an intervention study in persons with MS and fatigability, comparing dance with a sham intervention, and its effects primarily on fatigability outcomes.
详细描述
The study will have two parts (A and B). Part A includes 60 persons with Multiple Sclerosis (pwMS) and 30 healthy controls. The study consists of 2 test sessions, separated by 5-7 days of interval. The sessions 1 and 2 will be composed of cognitive test battery, questionnaires to be filled, information about the use of actigraph, clinical outcomes and interlimb coordination tests.
In the Part B the investigators propose a pilot randomized controlled trial with dance therapy to improve fatigability in pwMS. The study includes 24 pwMS presenting walking fatigability. The participants will be randomly allocated by group (n=3-4), by a person independent from the research, into the intervention group (Dance Therapy) or the active control group (control exercise). Interventions take place in groups of 3 or 4 people with MS, twice a week for eight weeks, complementary to their usual care or conventional physiotherapy.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons with MS presenting walking-related fatigability (Distance walk index ≤-10);
- •age between 30 and 70 years old;
- •a diagnosis of MS (2017 revisions of the McDonalds criteria) with Expanded Disability Status Scale (EDSS) 4 up to 6.
- •no relapses >1 month preceding the start of the study
- •ability to walk for 6 minutes without rest.
排除标准
- •Cognitive impairment hindering understanding of study instructions,
- •pregnancy
- •musculoskeletal disorders in the lower limbs not related to MS.
结局指标
主要结局
the symbol digit modality test (SDMT)
时间窗: week 8
The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than five minutes.
The 6 minute walking test
时间窗: week 8
Participants will perform the 6-minute walking test. The distance walked in each minute will be collected to calculate the Distance Walked Index (DWI) as follow: DWI = (Distance covered in the last minute - distance covered in the first minute)/distance covered in the first minute\*100.
The phase coordination index (PCI)
时间窗: week 8
The phase coordination index (PCI) will be used to analyse the consistency and accuracy in generating antiphase left-right knee movements on an instrumented chair. Participants will be instructed to perform antiphase movements of knee flexion and extension.
Movement Amplitude- Chair Coordination test
时间窗: Week 8
Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement amplitude: peak-to-peak amplitude for each individual cycle.
Movement Frequency- Chair Coordination test
时间窗: week 8
Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include movement frequency: the number of complete movements performed during one minute.
Workload- Chair Coordination test
时间窗: week 8
Participants will be instructed to perform antiphase movements of knee flexion and extension on an instrumented chair. Intralimb spatiotemporal parameters per cycle of successive peak extension positions, and averaged per minute will include workload (movement frequency\*movement amplitude): average amplitude multiplied by the frequency, to quantify the interaction pattern.
Motor fatigability during the 6 minutes condition
时间窗: week 8
Motor fatigability during the 6 minutes condition (amplitude; frequency; workload): the percentage decline from the last minute (min 6) to the first minute will be calculated, based on the Distance Walking Index formula, for every coordination outcome.
the paced auditory serial addition test (PASAT)
时间窗: week 8
the paced auditory serial addition test (PASAT) to measure the cognitive fatigability
次要结局
- Spatiotemporal gait parameter- Stride length(week 8)
- 25-foot walk test (T25FW)(week 8)
- Spatiotemporal gait parameter- Cadence(week 8)
- the MFIS (modified fatigue impact scale)(week 8)
- Spatiotemporal gait parameter- Double support(week 8)
- Short Form of the International Physical Activity Questionnaire (IPAQ-SF)(week 8)
- Physical activity by means of step count(week 8)
- Spatiotemporal gait parameter- Gait speed(week 8)
- the nine-hole peg test (NHPT)(week 8)
- the 6-minute walking test(week 8)
- VAS (visual analogue scale)(week 8)
- Multiple Sclerosis Walking Scale-12 item (MSWS-12)(week 8)
- The Pittsburgh Sleep Quality Index (PSQI)(week 8)
研究者
Peter Feys
Principal Investigator
Hasselt University