mHealth Technology in People With Parkinson's Disease (HomTrainPark)

Feasibility and Efficacy of a Home Exercise Program Using 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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: ROXPro© system (A-Champs); Other: No exercise program

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Fernandez del Olmo; Phone Number: 0034600077866; Email: miguel.delolmo@urjc.es
• Study Contact Backup: Name: Alfonso Jimemez Gutierrez; Phone Number: 0034914888401; Email: alfonso.jimenez@urjc.es

Study Locations

• Spain
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Recruiting
      • Universidad Rey Juan Carlos
      • Contact: Miguel Angel Fernández del Olmo, PhD; Phone Number: 600077866; Email: miguel.delolmo@urjc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs)	Device: 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.
Active Comparator: Control Group; 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; The control group did not received the physical exercise program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 0801202000720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No