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OpenTrials
Completed

NCT Number: NCT05829915

mHealth Technology in People With Parkinson's Disease

The main objective of the study is to explore the feasibility and effectiveness of this type of mHalth technology in the treatment of motor symptoms in people with Parkinson's disease.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, 28942, Spain

About this study

Parkinson's disease (PD) is a neurological disease whose motor symptoms drastically affect the quality of life of those who suffer from it. There is currently high scientific evidence of the positive effect of physical exercise on the motor function of people with PD. This effect seems to be more relevant when this physical exercise is implemented with external sensory signals (eg visual, auditory). However, the health and socioeconomic context of the patient conditions their access to treatments and physical exercise programs, associationism being common as a low-cost strategy to cover the different therapies. The development of telemedicine, electronic devices and mobile health applications could be an interesting option for those patients who find themselves in the situations mentioned above. However, there are several limitations regarding the use of mobile health apps, such as that less than

1% of them are grounded in research evidence and the digital barrier. Therefore, the main objective of the study is to explore the feasibility and effectiveness of this type of mHalth technology in the treatment of motor symptoms in people with Parkinson's disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).

In the case of subjects who are part of the intervention group, the following will also be inclusion criteria:

  • Caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application.
  • Availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers.

Exclusion criteria

  • Insufficient physical condition for participation.
  • Sensory deficits that make participation difficult.
  • Unstable clinical situation.
  • Unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.).
  • Presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation

Treatment and study plan

ROXPro© system (A-Champs)

Device

The intervention consisted in 24 sessions (3/week) of a cognitive-multisensory-physical exercise program carried out in the patient's own home. The exercise program was designed by qualified personal trainers and psychologists, and implemented with the ROXPro© system (A-Champs) (https://a-champs.com; accessed on 8 January 2022). This system consists of small devices that provide visual, auditory and vibration stimuli with which the patient interacts. Through its mobile application, it allows the development of numerous sensory-cognitive-motor exercises adapted to the characteristics of the patients.

No exercise program

Other

The control group did not received the physical exercise program

Primary outcomes

  1. Speed of gait at preferred pace

    Time frame: baseline

    Speed (m/s)

  2. Speed of gait at preferred pace

    Time frame: at week 8

    Speed (m/s)

  3. Cadence of gait at preferred pace

    Time frame: Baseline

    cadence (steps/min)

  4. Cadence of gait at preferred pace

    Time frame: At week 8

    cadence (steps/min)

  5. Step Length of gait at preferred pace

    Time frame: Baseline

    Step Length (m)

  6. Step Length of gait at preferred pace

    Time frame: At week 8

    Step Length (m)

Secondary outcomes

  1. Time up & go test

    Time frame: Baseline

    Time (seconds)

  2. Time up & go test

    Time frame: At week 8

    Time (seconds)

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Feasibility and Efficacy of a Home Exercise Program Using mHealth Technology in People With Parkinson's Disease

Acronym: HomTrainPark

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 26, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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