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临床试验/NCT07380737
NCT07380737招募中不适用

Feasibility and Preliminary Effects of the Walking Tall App for Home-Based Gait Training in Parkinson's Disease: A Pilot Study

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Average Step Count Per Day

研究概览

简要总结

This is a pilot study designed to assess the feasibility, adherence, and preliminary effects of a 6-week home-based gait training intervention using the Walking Tall mobile app in individuals with Parkinson's disease. The app delivers rhythmic auditory cues and motivational verbal prompts to promote gait improvements. Primary outcomes include daily walking duration and step count measured via wearable sensors; secondary outcomes include gait speed, balance, self-reported confidence, and usability.

详细描述

This open-label, single-arm feasibility study will recruit 30 participants with idiopathic Parkinson's disease, currently enrolled in a rehabilitation program at the Ezra LeMarpe Organization in Israel. Participants will perform 4-5 walking sessions per week for 6 weeks using the Walking Tall smartphone application. The app delivers rhythmic cueing and motivational prompts to enhance walking speed, stride length, and confidence. The study includes baseline and post-intervention assessments. Walking behavior will be monitored using a tri-axial accelerometer worn for 7 days at each timepoint. The primary aim is to evaluate feasibility, adherence, and changes in daily walking activity, with secondary outcomes addressing gait parameters and user satisfaction. Findings will guide the design of future randomized controlled trials.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of idiopathic Parkinson's disease (MDS criteria);
  • Hoehn & Yahr stage II-III (ON-medication state);
  • Able to walk independently for ≥5 minutes;
  • Stable medication for ≥1 month;
  • Currently enrolled in a rehab program at Ezra LeMarpe;
  • Able to provide written informed consent;

排除标准

  • Musculoskeletal, neurological, or visual/hearing impairments affecting gait;
  • Cognitive impairments or severe behavioral symptoms;
  • History of stroke, severe TBI, or brain tumor;
  • Cardiovascular contraindications;
  • Inability to use a smartphone;
  • Participation in other concurrent intervention studies.

研究组 & 干预措施

Walking Tall App Intervention

Experimental

Participants will use the Walking Tall smartphone app to complete 4-5 home-based walking sessions per week for 6 weeks. The app provides rhythmic auditory cues and verbal prompts to improve gait quality.

干预措施: Walking Tall App (Behavioral)

结局指标

主要结局

Average Step Count Per Day

时间窗: Time Frame: Baseline and 6 weeks

Measured via accelerometer

Daily Walking Duration (minutes/week)

时间窗: Time Frame: Baseline and 6 weeks

Measured using tri-axial accelerometer (Axivity) over 7 days

次要结局

  • Gait Speed (m/s) - single- and dual-task(Time Frame: Baseline and 6 weeks)
  • Short Physical Performance Battery (SPPB)(Time Frame: Baseline and 6 weeks)
  • Timed Up and Go (TUG) - single- and dual-task(Time Frame: Baseline and 6 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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