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Recruiting NCT07380737

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

No phase Interventional Parkinson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Walking Tall App.
Who it may be relevant to
Registry conditions: Parkinson's Disease. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Average Step Count Per Day [Time frame: Time Frame: Baseline and 6 weeks]
  • Daily Walking Duration (minutes/week) [Time frame: Time Frame: Baseline and 6 weeks]
Secondary outcome measures (3)
  • Gait Speed (m/s) - single- and dual-task [Time frame: Time Frame: Baseline and 6 weeks]
  • Short Physical Performance Battery (SPPB) [Time frame: Time Frame: Baseline and 6 weeks]
  • Timed Up and Go (TUG) - single- and dual-task [Time frame: Time Frame: Baseline and 6 weeks]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Tel Aviv Sourasky Medical Center (Ichilov Hospital) — Tel Aviv

Publications

  • 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

Identifiers

NCT: NCT07380737 · 0481_25_TLV_TG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗