Effects of a Telerehabilitation Program of Central Stability Exercises to Improve Balance and Gait in Hereditary Ataxia. A Randomized Controlled Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Rate of dynamic sitting balance and trunk coordination
研究概览
简要总结
Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. Improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with HA.
Evidence suggests that rehabilitation strategies based on core stability exercises (CSE) are effective in improving balance and postural control in several neurological diseases, such as stroke. However, there is little evidence with people with HA. In a previous study carried out by researchers of this project, in which an EEC exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. Therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.
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
- Double (Participant, 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
- •Suffer from degenerative HA at any stage of the disease (Spinocerebellar ataxia, Friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom).
- •Adults over 18 years of age.
- •Be able to use a computer or mobile phone (It will be evaluated using the DILE scale)
- •Have an internet connection.
排除标准
- •Suffer from other neurological diseases and inability to follow simple instructions. -
- •Suffering from a musculoskeletal injury that prevents you from performing the exercises.
- •Being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the SARA scale).
结局指标
主要结局
Rate of dynamic sitting balance and trunk coordination
时间窗: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
panish-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.
Walking Speed
时间窗: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
The walking speed will be determined with the 4 meter walking test.
Static sitting balance and Standing balance
时间窗: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Static sitting balance will be recorded with the sitting section of SARA, standing balance will be recorded with the standing section of SARA as well, as well as walking.
次要结局
- ADLs(T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks)
- Risk of falls(T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks)
- Severity of ataxia(T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks)
- Treatment compliance(T1: 7 weeks and T0: follow up 7 weeks)
- Lower extremity strength(T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks)
- Adherence to treatment(T1: 7 weeks and T0: follow up 7 weeks)
- Program satisfaction(T1: 7 weeks)
研究者
Maria Masbernat-Almenara
Principal Investigator
Universitat de Lleida