search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ROXPro© system (A-Champs)
No exercise program
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universidad Rey Juan CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs)

Subjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy

Outcomes

Primary Outcome Measures

Speed of gait at preferred pace
Speed (m/s)
Speed of gait at preferred pace
Speed (m/s)
Cadence of gait at preferred pace
cadence (steps/min)
Cadence of gait at preferred pace
cadence (steps/min)
Step Length of gait at preferred pace
Step Length (m)
Step Length of gait at preferred pace
Step Length (m)

Secondary Outcome Measures

Time up & go test
Time (seconds)
Time up & go test
Time (seconds)

Full Information

First Posted
April 13, 2023
Last Updated
April 13, 2023
Sponsor
Universidad Rey Juan Carlos
search

1. Study Identification

Unique Protocol Identification Number
NCT05829915
Brief Title
mHealth Technology in People With Parkinson's Disease
Acronym
HomTrainPark
Official Title
Feasibility and Efficacy of a Home Exercise Program Using mHealth Technology in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Subjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy
Intervention Type
Device
Intervention Name(s)
ROXPro© system (A-Champs)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No exercise program
Intervention Description
The control group did not received the physical exercise program
Primary Outcome Measure Information:
Title
Speed of gait at preferred pace
Description
Speed (m/s)
Time Frame
baseline
Title
Speed of gait at preferred pace
Description
Speed (m/s)
Time Frame
at week 8
Title
Cadence of gait at preferred pace
Description
cadence (steps/min)
Time Frame
Baseline
Title
Cadence of gait at preferred pace
Description
cadence (steps/min)
Time Frame
At week 8
Title
Step Length of gait at preferred pace
Description
Step Length (m)
Time Frame
Baseline
Title
Step Length of gait at preferred pace
Description
Step Length (m)
Time Frame
At week 8
Secondary Outcome Measure Information:
Title
Time up & go test
Description
Time (seconds)
Time Frame
Baseline
Title
Time up & go test
Description
Time (seconds)
Time Frame
At week 8

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Fernandez del Olmo
Phone
0034600077866
Email
miguel.delolmo@urjc.es
First Name & Middle Initial & Last Name or Official Title & Degree
Alfonso Jimemez Gutierrez
Phone
0034914888401
Email
alfonso.jimenez@urjc.es
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Angel Fernández del Olmo, PhD
Phone
600077866
Email
miguel.delolmo@urjc.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

mHealth Technology in People With Parkinson's Disease

We'll reach out to this number within 24 hrs