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

U

Universidad Rey Juan Carlos

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: No exercise program
Device: ROXPro© system (A-Champs)

Study type

Interventional

Funder types

Other

Identifiers

NCT05829915
0801202000720

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

114 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Miguel Fernandez del Olmo; Alfonso Jimemez Gutierrez

Data sourced from clinicaltrials.gov

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