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

February 12, 2026 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center (Ichilov Hospital)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Walking Tall App Intervention
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Step Count Per Day
Time Frame: Time Frame: Baseline and 6 weeks
Measured via accelerometer
Time Frame: Baseline and 6 weeks
Daily Walking Duration (minutes/week)
Time Frame: Time Frame: Baseline and 6 weeks
Measured using tri-axial accelerometer (Axivity) over 7 days
Time Frame: Baseline and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait Speed (m/s) - single- and dual-task
Time Frame: Time Frame: Baseline and 6 weeks
Assessed using a 1-minute walking test under two conditions: (1) single-task (normal walking) and (2) dual-task (walking while performing a cognitive task such as serial subtraction). Gait speed is calculated in meters per second based on distance walked over time in each condition.
Time Frame: Baseline and 6 weeks
Short Physical Performance Battery (SPPB)
Time Frame: Time Frame: Baseline and 6 weeks
The SPPB is a standardized test that evaluates lower extremity function using three components: balance (side-by-side, semi-tandem, tandem stance), gait speed over a 4-meter walk, and chair stands. Each component is scored from 0 to 4, with a total score ranging from 0 (worst performance) to 12 (best performance).
Time Frame: Baseline and 6 weeks
Timed Up and Go (TUG) - single- and dual-task
Time Frame: Time Frame: Baseline and 6 weeks
The TUG test measures functional mobility by timing how long it takes a participant to stand up from a chair, walk 3 meters, turn, return, and sit down. It is performed under two conditions: (1) single-task (normal walking) and (2) dual-task (walking while performing a cognitive task, such as serial subtraction). The test evaluates gait, balance, and cognitive-motor integration.
Time Frame: Baseline and 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported questionnaires: Activities-specific Balance Confidence (ABC)
Time Frame: Time Frame: Baseline and 6 weeks
Activities-specific Balance Confidence (ABC) Scale A 16-item self-report questionnaire assessing participants' confidence in performing various daily activities without losing balance or becoming unsteady. Scores range from 0% (no confidence) to 100% (complete confidence), with higher scores indicating greater balance confidence.
Time Frame: Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel-Aviv Sourasky Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tatyana Gurevich, Prof, Head of the Movement Disorders Unit at Ichilov Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0481_25_TLV_TG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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