Recruiting

Telemedicine App

Sponsor:

Altec Inc.

Code:

NCT06245174

Conditions

Parkinson Disease(PD)

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This observational research study is designed to assess the feasibility of developing a new software application that can be used in the home using a commercially available camera to measure abnormal body movements associated with Parkinson's disease (PD). The goal of this study is to validate the motor outcomes derived from a consumer camera observing a sub-set of standardized assessment tasks with respect to the reference motion capture system.

Conditions

Parkinson Disease(PD)

Study ID

NCT06245174

Start date

May 11, 2023

Status verified date

Jan, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female;
  • 35 years of age or older;
  • Physician-diagnosed Parkinson's disease or other movement disorder such as Essential Tremor or Dystonia;
  • One or more mild to moderate motor symptoms of PD (tremor, bradykinesia, akinesia, Parkinsonian gait);
  • Hohn and Yahr (Stage I-III);
  • Independent ambulator - walker or cane allowed;
  • Referring neurologist indicates that prospective subject is not at high fall risk and can safely participate in the study;
  • Have participated in prior telehealth visits using videoconferencing app;
  • Have used a smartphone in past to record videos;
  • Able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
  • American-English speaking; able to follow directions in English;
  • Normal hearing.

Exclusion Criteria:

  • Inability to understand spoken English or follow simple instructions;
  • Inability to provide written informed consent.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Parkinson's disease (PD)

Individuals with mild to severe movement disorder symptoms of Parkinson's disease

Primary outcome measure

  • Tremor Duration [ Time Frame: 2 minute ]
  • Tremor Amplitude [ Time Frame: 2 minute ]
  • Parkinsonian Gait - Step Length [ Time Frame: 5 minute ]
  • Parkinsonian Gait - Step Time [ Time Frame: 5 minute ]
  • Parkinsonian Gait - Step Variability [ Time Frame: 5 minute ]
  • Bradykinesia Finger Tap Duration [ Time Frame: 2 minute ]
  • Bradykinesia Finger Tap Amplitude [ Time Frame: 2 minute ]
  • Bradykinesia Foot Tap Duration [ Time Frame: 2 minute ]
  • Bradykinesia Foot Tap Amplitude [ Time Frame: 2 minute ]
  • Bradykinesia Foot Stomping Duration [ Time Frame: 2 minute ]
  • Bradykinesia Foot Stomping Amplitude [ Time Frame: 2 minute ]

Central Contacts and Locations

Central contacts

Bhawna Shiwani, MS

(508)545-8217bshiwani@altecresearch.com

Serge Roy, ScD, PT

(508)545-8235sroy@delsys.com

Locations

Altec Inc.

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Bhawna Shiwani, MS

508-545-8217bshiwani@altecresearch.com

More Information

Sponsor

Altec Inc.

Last update posted

Jul 30, 2024

Last verified

Jan, 2024

Keywords

  • Movement Disorders
  • Parkinson's Disease
  • 3D Camera
  • Smartphone
  • Motor Assessment
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Altec Inc. on 2024-07-30.