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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Walking Tall App
  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.

Первичные конечные точки

• Average Step Count Per Day [Срок оценки: Time Frame: Baseline and 6 weeks]
• Daily Walking Duration (minutes/week) [Срок оценки: Time Frame: Baseline and 6 weeks]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Tel Aviv Sourasky Medical Center (Ichilov Hospital) — Tel Aviv

Публикации

• Brodie, M. A., & University of New South Wales. (2023, August 7). New app is a step towards helping people with Parkinson's disease walk more confidently. UNSW Newsroom. Retrieved from https://www.unsw.edu.au/newsroom/news/2023/08/new-app-is-a-step-towards-helping-people-with-parkinsons-disease

Идентификаторы

NCT: NCT07380737 · 0481_25_TLV_TG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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