Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Urinary frequency
研究概览
简要总结
The aim of the study (OVERACT_V1) is to verify if the isometric contraction of ankle plantarflexor and Hamstring muscles, induces a significant reduction of overactive bladder symptoms in patients with Multiple sclerosis.
详细描述
The aim of the study (OVERACT_V1) is to verify if the isometric contraction of ankle plantarflexor and Hamstring muscles, induces a significant reduction of overactive bladder symptoms in patients with Multiple sclerosis. It's known that the electric stimulation of the Posterior Tibial nerve induces an improvement of overactive bladder symptoms through a modulation of spinal circuitry, which occurs with unknown mechanisms. The investigators' hypothesis is that the voluntary muscular activation may induce a modulation of the sacral root as long as the electric stimulation. 30 patients will be recruited within 2 years, since October 2017 through October 2019. This is a monocentric, randomized controlled , in single blind, not pharmacological study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis Patients
- •Urge score >=2
- •urinary daytime frequency >=8
- •stable overactive bladder symptoms for 6 months
- •MRC ( Medical Research Council) scale of ankle plantarflexors and hamstrings >=2
- •signed informed consensus
排除标准
- •FIM ( Functional Independence Measure) memory items <=4
- •impairment in registering bladder diary
- •inclusion in other experimental study
- •specific straightening during the suty period
- •PVR >= 200 ml ina single evaluation or PVR (post void residual) >=150 in 4 evaluation (twice a day for 2 consecutive days)
- •Urinary infections
- •concomitant urological disease
- •intrathecal baclofen pump
- •SANS (Stoller Afferent Nerve Stimulation)
- •modification of therapy for overactive bladder symptoms within three months before entering the study
研究组 & 干预措施
Control group
Usual physical therapy
干预措施: Usual physical therapy (Other)
Experimental group
Usual physical therapy+ strengthening of lower limbs muscles
干预措施: Usual physical therapy+ strengthening of lower limbs muscles (Other)
结局指标
主要结局
Change of Urinary frequency
时间窗: at 6th and 22nd day
mean of voluntary urination episodes daytime during 4 days of bladder diary
Change of Urge score
时间窗: at 6th and 22nd day
mean of score evaluating the perception of urge that patient experiences every urination. The subscale scores are: * 0, if patient doesn't need to urinate, but urinates before going out from home or concerned about the unavailability of toilet; * 1, if patient doesn't experience urgent urination; * 2, presence of urgency but disappeared before getting to the toilet; * 3, presence of urgency and reached the toilet without leakage of urine * 4, presence of urgency and did not reach the toilet with leakage of urine
Change of total score of OAB-q ( Overact Bladder questionnaire) long form
时间窗: at 3rd and 18th day
questionnaire evaluates the impact of overactive bladder symptoms on activities of daily living 8 ITEMS SYMPTOM BOTHER (each item has a subscale score from 1 to 6) + 25 ITEMS HEALTH-RELATED QUALITY OF LIFE (each item has a subscale score from 1 to 6)
次要结局
- Change of Urine volume(at 6th and 22nd day)
- Change of episodes of urinary incontinence(at 6th and 22nd day)
- Change of episodes of nocturia(at 6th and 22nd day)
- Change of Postvoid Residual Volume(at 3rd and 18th day)
- Change of MAS (Modified Ashworth Scale )(at 2nd and 22nd day)
- Change of Pad-test 24 Hours(at 6th and 22nd day)
- Change of value at Uroflussimetry(at 3rd and 18th day)
- PGI (Patient global impression of improvement)(at 18th day)
- Change of value at "H REFLEX" test(at 6th and 22nd day)
- Change of EDSS (Expanded Disability Status Scale)(at 2nd and 22nd day)
- Change of Barthel Index Score(at 2nd and 22nd day)
研究者
Giancarlo Comi
Director of Department of Neurology and Institute of Experimental Neurology
IRCCS San Raffaele