mHealth Technology in People With Parkinson's Disease

Parkinson Disease Clinical Trial

— HomTrainPark  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829915
• Other study ID #: 0801202000720
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: April 2023
• Source: Universidad Rey Juan Carlos
• Contact: Miguel Fernandez del Olmo
• Phone: 0034600077866
• Email: miguel.delolmo[@]urjc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Other:
• No exercise program
The control group did not received the physical exercise program

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Fuenlabrada	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of gait at preferred pace	Speed (m/s)	baseline
Primary	Speed of gait at preferred pace	Speed (m/s)	at week 8
Primary	Cadence of gait at preferred pace	cadence (steps/min)	Baseline
Primary	Cadence of gait at preferred pace	cadence (steps/min)	At week 8
Primary	Step Length of gait at preferred pace	Step Length (m)	Baseline
Primary	Step Length of gait at preferred pace	Step Length (m)	At week 8
Secondary	Time up & go test	Time (seconds)	Baseline
Secondary	Time up & go test	Time (seconds)	At week 8