A Telerehabilitation Intervention Targeting Core Stability and Muscular Strength in Individuals With Moderate-to-Advanced Hereditary Ataxia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dynamic sitting balance and coordination
研究概览
简要总结
This is a two-arm, controlled clinical trial with a parallel design. Participants will be randomly assigned to an intervention or control group. The study is single-blind, as outcome assessors will be blinded to group allocation, while participants and physiotherapists cannot be blinded due to the nature of the intervention. Consecutive sampling will be applied.
For the evaluation of intervention effects (primary and secondary outcomes), the study will follow the Consolidated Standards of Reporting Trials (CONSORT) for non-pharmacological interventions. For the assessment of satisfaction and adherence, a qualitative study will be conducted following the COREQ EQUATOR 17 guidelines to ensure methodological rigor.
The intervention will consist of a 12-week home-based exercise program supervised via mixed telerehabilitation (TR). The control group will perform the same program but receive only telephone follow-up. Four assessments will be conducted: baseline (T0), post-intervention (T1), three months follow-up (T2), and six months follow-up (T3).
详细描述
This study is a two-arm, controlled, parallel-group clinical trial designed to evaluate the effectiveness, adherence, and satisfaction of a telerehabilitation (TR) program combining core stability and strength exercises with an educational component for people with moderate hereditary ataxia.
Participants will be consecutively recruited through the Catalan Association of Hereditary Ataxias (ACAH), the CSUR Centre for Ataxias and Hereditary Spastic Paraparesis at Hospital Clínic de Barcelona. Eligible participants must have a diagnosis of hereditary spinocerebellar ataxia, moderate severity according to the SARA scale (10-20 points), internet access, basic digital literacy, and provide informed consent.
Participants will be randomly allocated to an intervention or control group. The intervention group will receive three preliminary online educational sessions and then follow a 12-week home-based exercise program delivered through a dedicated telerehabilitation platform. The platform includes pre-recorded videos, weekly synchronous physiotherapy sessions, automated reminders, personal diaries, and interactive features to promote adherence and engagement.
The control group will complete the same 12-week exercise program using printed materials and videos hosted in a cloud repository, supported only by periodic telephone follow-up, without educational sessions or access to the platform.
All participants will undergo four assessments: baseline (T0), post-intervention (T1), and follow-ups at three months (T2) and six months (T3).
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)
盲法说明
The outcome assessor will remain blinded to group allocation. Due to the nature of the intervention, participants and physiotherapists cannot be blinded.
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
- •Confirmed diagnosis of spinocerebellar hereditary ataxia.
- •Moderate severity defined by the SARA scale (10-20 points, Traschütz et al., 2023).
- •Stable internet access and suitable electronic devices.
- •Basic digital literacy.
- •Signed informed consent.
排除标准
- •Mild (<10) or severe (>20) scores on the SARA scale.
- •Severe comorbidities preventing safe exercise participation.
- •Severe cognitive impairment that would preclude program adherence.
研究组 & 干预措施
Intervention group. TR mixed mode
Intervention group: Participants will perform the 12-week exercise program with access to a specially developed telerehabilitation platform. The platform will include videos, questionnaires, a personal diary, automatic reminders, a social chat, and one weekly synchronous supervision session with a physiotherapist to correct technique and adjust progression.
干预措施: TR Mixed CORE Exercices (Other)
Control group: Asynchronous mode
Control group: Participants will perform the same exercise program at home but will only receive printed material and videos uploaded to a cloud repository, along with telephone follow-up. They will not have access to the telerehabilitation platform or synchronous sessions.
干预措施: TR Asyncronous CORE Exercices (Other)
结局指标
主要结局
Dynamic sitting balance and coordination
时间窗: Baseline (T0) , post-intervention (up to 12 weeks), (T1), and follow-ups at 3 months (T2) and 6 months (T3).
Dynamic sitting balance and coordination will be assessed using the Spanish version of the Trunk Impairment Scale (S-TIS 2.0). This scale has a total score range from 0 to 16 points, where higher scores indicate better trunk control, balance, and coordination, and lower scores indicate poorer performance.
次要结局
- Functional mobility and fall risk(Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Static sitting and standing balance(Baseline (T0), post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Lower limb functional strength(Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Transfer ability(Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Upper limb functionality(Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Walking Speed(Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Gait Performance(Baseline (T0), post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3))
- Disease severity(Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Program Compliance(Post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Exercise Adherence(Post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3).)
- Satisfaction, perceived benefits, risks, and acceptability(Post-intervention (up to 12 weeks)(T1))
研究者
Maria Masbernat-Almenara
Principal Investigator
Universitat de Lleida