Clinical trial NCT05829915: mHealth Technology in People With Parkinson's Disease
Official title: Feasibility and Efficacy of a Home Exercise Program Using mHealth Technology in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speed of gait at preferred pace
timeFrame: baseline
measure: Speed of gait at preferred pace
timeFrame: at week 8
measure: Cadence of gait at preferred pace
timeFrame: Baseline
measure: Cadence of gait at preferred pace
timeFrame: At week 8
measure: Step Length of gait at preferred pace
timeFrame: Baseline
measure: Step Length of gait at preferred pace
timeFrame: At week 8
Secondary outcomes:
measure: Time up & go test
timeFrame: Baseline
measure: Time up & go test
timeFrame: At week 8
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: