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Clinical Trials/NCT05829915
NCT05829915
Completed
N/A

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

Universidad Rey Juan Carlos1 site in 1 country114 target enrollmentMarch 30, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Universidad Rey Juan Carlos
Enrollment
114
Locations
1
Primary Endpoint
Step Length of gait at preferred pace
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2023
End Date
April 30, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miguel Fernández del Olmo

Proffessor

Universidad Rey Juan Carlos

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

Outcomes

Primary Outcomes

Step Length of gait at preferred pace

Time Frame: At week 8

Step Length (m)

Speed of gait at preferred pace

Time Frame: at week 8

Speed (m/s)

Cadence of gait at preferred pace

Time Frame: At week 8

cadence (steps/min)

Secondary Outcomes

  • Time up & go test(At week 8)

Study Sites (1)

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