mHealth Technology in People With Parkinson's Disease

NCT ID: NCT05829915

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2025-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs)

Group Type: EXPERIMENTAL

ROXPro© system (A-Champs)

Intervention Type: 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.

Control Group

Subjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy

Group Type: ACTIVE_COMPARATOR

No exercise program

Intervention Type: OTHER

The control group did not received the physical exercise program

Interventions

ROXPro© system (A-Champs)

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.

Intervention Type: DEVICE

No exercise program

The control group did not received the physical exercise program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Miguel Fernández del Olmo

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, Spain

Countries

Spain

Other Identifiers

0801202000720

Identifier Type: -

Identifier Source: org_study_id