ACTRN12618000908235招募中未知
The efficacy of rehabilitation on motor function in individuals with hereditary cerebellar ataxia. A randomised controlled trial.
Murdoch Children's Reseach Institute0 个研究点目标入组 80 人开始时间: 2018年5月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 15 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Have a molecular diagnosis or at least three generations affected, of a recessive or dominant inherited cerebellar ataxia.
- •2. Aged over 15 years
- •3. A minimum score of 2 for question 1: Gait of the Scale for the Assessment and Rating of Ataxia (SARA) [2 = Gait clearly abnormal, tandem walking > 10 steps not possible].
- •4. A minimum score of 4 for item I: Transfers Bed, Chair, Wheel-chair of the Functional Independence Measure [4 = Minimal Assistance, the participant completes 75% or more of the task].
- •5. Given clearance by cardiologist or other appropriate medical professional for participation in rehabilitation and the hydrotherapy component.
- •6. Able to give informed consent.
排除标准
- •1. Individuals with non-genetic ataxia or non-degenerative ataxia.
- •2. Musculoskeletal injury limiting ability to weight-bear.
- •3. Another medical condition not related to their hereditary cerebellar ataxia that impacts on mobility.
- •4. Undergone major orthopaedic surgery in the last six months.
- •5. Need for immediate intensive intervention for safety reasons.
- •6. Pregnancy.
- •7. Dementia or significant cognitive impairment limiting ability to give informed consent and participate in the rehabilitation program.
- •8. Received botulinum toxin injections for spasticity management (except for regular longstanding paraspinal botulinum injections - this is defined as at least two doses of botulinum injections in the same muscle/s within eight months of the screening period).
- •9. Already completing greater than three hours per week physical exercise/therapy focused on the lower limb (i.e. pilates, personal trainer, home exercise program, independent gym program, exercise physiology) or is participating in a structured goal-based physiotherapy rehabilitation program. This does not include physical activity that occurs as part of the person's daily life, i.e. walking to the shops.
- •10. Currently enrolled in a clinical trial or planned enrolment in a clinical trial during the period of the study.
- •11. Has a medical condition that precludes entry into a hydrotherapy pool, including bowel incontinence.
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