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临床试验/NCT04750850
NCT04750850已完成不适用

The Effectiveness of Core Stability Exercises to Improve Balance and Gait in Hereditary Ataxias. Pilot Study

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Rate of dynamic sitting balance and trunk coordination

研究概览

简要总结

The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and balance impairments in sitting and standing. Trunk local stability during gait is lower in patients with degenerative ataxia than that in healthy adult population.

Given the fact that drug interventions are rare in degenerative diseases and limited to only specific type of diseases and symptoms, physiotherapy is a major cornerstone in current therapy of ataxic gait. Core stability exercises training could be included as an adjunct to conventional balance training in improving dynamic balance and gait. Due to the nature of the interventions, the study will have a single blind design.

详细描述

The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. Prevalence of the autosomal dominant cerebellar ataxias (ADCAs) is estimated to be approximately 1-5:100,000 populations. Hereditary ataxia may result from: dysfunction of the cerebellum and its associated system, lesions in the spinal cord and/or peripheral sensory loss.

Clinical manifestations of hereditary ataxia are poor coordination of movement and a wide-based, uncoordinated, unsteady gait. Poor coordination of the limbs and of speech (dysarthria) are often present. Ataxia patients perceive impairments in balance, coordination and speech as the symptoms with greatest impact, as well as fatigue.

Postural disorders in cerebellar ataxia constitute a major cause of poor balance. Local stability of the trunk during gait in patients with cerebellar degenerative ataxia is lower than that in controls. To compensate for this instability, walkers increase the width of the base of support, take smaller steps and increase the duration of foot contact to the floor, sacrificing swing phase. They progress forward slower, with a lower cadence and preferred walking pace. This lack of stability is in turn correlated with the history of falls. Local stability of the trunk may thus be useful when planning gait and balance rehabilitation in patients with ataxia. Developing core strength is essential for everyday health and well-being, as a strong core protects the spine, reduces back pain, enhances movement patterns, and improves balance, stability and posture. However, while motor training programs have been shown to be beneficial in other neurodegenerative diseases (e.g., Parkinson's disease or stroke, their effectiveness remains controversial in the field of degenerative hereditary ataxias.

There's emerging evidence that rehabilitation may improve function, mobility, ataxia and balance in genetic degenerative ataxia. Although these conclusions are based primarily on moderate to low-quality studies, the consistency of positive effects verifies that rehabilitation is beneficial. Intensive rehabilitation (with balance and coordination exercises) improves the patients' functional abilities (level of proof: moderate). Although techniques such as virtual reality, biofeedback, treadmill exercises with supported body weight and torso weighting appear to be of value, their specific efficacy has yet to be characterized. This body of literature is limited by the wide range of underlying conditions studied and methodological weaknesses (small sample sizes, poorly described rehabilitation protocols, etc.

The aim of this study is that a program of core stability exercises could improve sitting and standing balance and gait in hereditary ataxia patients. Secondary objectives are activities of daily living, lower limb strength and health status of quality of life. After giving informed consent, participants will be randomly assigned (at a ratio 1:1) to core stability group or control group. Concealed treatment allocation will be performed via opaque envelopes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion criteria: suffer a degenerative hereditary ataxia. spinocerebellar ataxia (SCA), Friedreich's ataxia (FRDA), idiopathic sporadic cerebellar ataxia, and specific neurodegenerative disorders in which ataxia is the dominant symptom (e.g. cerebellar variant of multiple systems atrophy (MSA-C). Both sexes and age ≥ 18 years old. •Ability to understand and execute simple instructions.

排除标准

  • •Concurrent neurologic disorder (e. g. Parkinson's disease) or major orthopedic problem (e. g. amputation) that hamper sitting balance, relevant psychiatric disorders that may prevent from following instructions, Other treatments that could influence the effects of the interventions, Contraindication to physical activity (e.g., heart failure).

研究组 & 干预措施

Core stability exercises group

Experimental

30 minutes of core stability exercises program at a light intensity and take a rest breaks if is necessary. They will be instructed in the use of the 4-5 points of the Borg 10 Rating of Perceived Exertion for self-monitoring of exercise intensity. The exercises will performed twice a day for 5 days a week during 5 weeks. A physiotherapist conducted an initial home visit to ensure correct execution of the exercises. He or she will teach the exercises and then the patient will perform them alone in your home. Once a week the physiotherapist will phone the patient and will ask her/him for doubts.

干预措施: Therapeutic core stability exercises (Other)

Control group

Active Comparator

The patients to continue as normal and not change their routine in terms of exercise and physical activity during the period of study.

干预措施: Usual care (Other)

结局指标

主要结局

Rate of dynamic sitting balance and trunk coordination

时间窗: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks

Spanish-version of Trunk Impairment Scale 2.0. Each item will be performed three times and the highest score counts. Otherwise, no practice session allowed. The patient can be corrected between attempts. The tests are verbally explained to the patient and can be demonstrated if needed. There are two subscales: dynamic sitting balance and coordination. The first have 10 items and second 6. The highest possible total score is consequently 16 points, which indicates a good dynamic sitting balance and correct trunk control and sitting coordination. If the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total score for the scale is 0 points.

Rate of static sitting balance

时间窗: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks

Sitting section of Scale for the assessment and rating of ataxia (SARA). Patient is asked to sit on an examination bed without support of feet, eyes open and arms outstretched to the front. 0 Normal, no difficulties sitting \>10 seconds, 1 Slight difficulties, intermittent sway, 2 Constant sway, but able to sit \> 10 s without support, 3 Able to sit for \> 10 s only with intermittent support, 4 Unable to sit for \>10 s without continuous support

Rate of ataxia severity

时间窗: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks

Scale for the Assessment and Rating of Ataxia (SARA). The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating

次要结局

  • Rate of standing balance(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)
  • Rate of gait ability(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)
  • Rate of balance confidence(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)
  • Rate of lower limb strength(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)
  • Rate of adherence(T2: 5 weeks)
  • Rate of health status(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)
  • Rate of gait speed(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)
  • Rate of quality of life(T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosa Cabanas Valdés

PhD

Universitat Internacional de Catalunya

研究点 (1)

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