灵活性、阻力、有氧、运动执行（FRAME）训练计划以改善遗传性痉挛性截瘫成人的步态能力：单队列可行性试验方案
Flexibility, Resistance, Aerobic, Movement Execution (FRAME) training program to improve gait capacity in adults with Hereditary Spastic Paraplegia: protocol for a single-cohort feasibility trial.
作者信息
Boccuni Leonardo, Bortolini Marco, Stefan Cristina, Dal Molin Valentina, Dalla Valle Giacomo, Martinuzzi Andrea
机构信息
Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.
出版信息
Front Neurol. 2025 Feb 18;16:1441512. doi: 10.3389/fneur.2025.1441512. eCollection 2025.
BACKGROUND
Hereditary Spastic Paraplegia (HSP) is a heterogeneous group of inherited neurological disorders characterized by progressive weakness and spasticity in the lower limbs, significantly affecting gait capacity (endurance and speed). Although specific interventions have been already investigated, there is currently a lack of comprehensive, structured neurorehabilitation programs to improve gait capacity in adults with HSP. Thus, this protocol aims to explore the feasibility and effectiveness of a composite training targeting flexibility, muscle strength, motor control, balance, and aerobic capacity.
METHODS
20 adults diagnosed with HSP will participate in 10 to 16 therapist-guided sessions (intervention), lasting 60 to 120 minutes each, occurring once or twice weekly based on individual preferences. Depending on the number and frequency of sessions, the intervention period may vary in between five to 10 weeks. Upon completion, participants will receive a transfer package (manual, video tutorials) to stimulate long-term exercise at home. Assessments will take place before intervention (T0), at the end of the intervention (T1), and 12 weeks post-T1 (T2). Primary outcomes will focus on feasibility (recruitment, retention, adherence, absence of adverse events, and patient's satisfaction). Secondary outcomes will evaluate improvements in gait capacity and specific contributing factors such as reduced spasticity, increased muscle strength, and improved balance.
RELEVANCE
The significance of this protocol is to provide valuable insights for clinicians regarding the feasibility and potential efficacy of a comprehensive, clinical-oriented program to improve gait capacity in adults with HSP, and inform future translational research studies in the field.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT06742697.
背景
遗传性痉挛性截瘫（HSP）是一组遗传性神经系统疾病，具有异质性，其特征为下肢进行性无力和痉挛，对步态能力（耐力和速度）有显著影响。尽管已经对特定干预措施进行了研究，但目前缺乏全面、结构化的神经康复计划来改善成年HSP患者的步态能力。因此，本方案旨在探索针对灵活性、肌肉力量、运动控制、平衡和有氧能力的综合训练的可行性和有效性。
方法
20名被诊断为HSP的成年人将参加10至16次由治疗师指导的课程（干预），每次课程持续60至120分钟，根据个人喜好每周进行一次或两次。根据课程的数量和频率，干预期可能在5至10周之间有所不同。完成后，参与者将收到一个转移包（手册、视频教程），以促进在家中长期锻炼。评估将在干预前（T0）、干预结束时（T1）以及T1后12周（T2）进行。主要结果将侧重于可行性（招募、保留、依从性、无不良事件和患者满意度）。次要结果将评估步态能力的改善以及特定的促成因素，如痉挛减轻、肌肉力量增加和平衡改善。
相关性
本方案的意义在于为临床医生提供有关全面、以临床为导向的计划改善成年HSP患者步态能力的可行性和潜在疗效的宝贵见解，并为该领域未来的转化研究提供信息。
临床试验注册
ClinicalTrials.gov，标识符NCT06742697。
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