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Clinical Trials/NCT07380737
NCT07380737
Recruiting
Not Applicable

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 site in 1 country30 target enrollmentStarted: December 29, 2025Last updated:
InterventionsWalking Tall App

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Average Step Count Per Day

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Walking Tall App (Behavioral)

Outcomes

Primary Outcomes

Average Step Count Per Day

Time Frame: Time Frame: Baseline and 6 weeks

Measured via accelerometer

Daily Walking Duration (minutes/week)

Time Frame: Time Frame: Baseline and 6 weeks

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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