mHealth Technology in People With Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: ROXPro© system (A-Champs); Other: No exercise program

• Registration Number: NCT05829915
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Study Timeline

• Study Start: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	ROXPro© system (A-Champs)	Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs)
Control Group	No exercise program	Subjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy

Primary Outcome Measures

Name	Time	Method
Speed of gait at preferred pace	at week 8	Speed (m/s)
Cadence of gait at preferred pace	At week 8	cadence (steps/min)
Step Length of gait at preferred pace	At week 8	Step Length (m)

Secondary Outcome Measures

Name	Time	Method
Time up & go test	At week 8	Time (seconds)

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Fuenlabrada, Madrid, Spain