mHealth Technology in People With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: ROXPro© system (A-Champs)
* Other: No exercise program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs) | Device: ROXPro© system (A-Champs)<br>* 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.<br>|
| Active Comparator: Control Group<br>Subjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy | Other: No exercise program<br>* The control group did not received the physical exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of gait at preferred pace | Speed (m/s) | baseline | 
| Speed of gait at preferred pace | Speed (m/s) | at week 8 | 
| Cadence of gait at preferred pace | cadence (steps/min) | Baseline | 
| Cadence of gait at preferred pace | cadence (steps/min) | At week 8 | 
| Step Length of gait at preferred pace | Step Length (m) | Baseline | 
| Step Length of gait at preferred pace | Step Length (m) | At week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time up & go test | Time (seconds) | Baseline | 
| Time up & go test | Time (seconds) | At week 8 |