Parkinson DiseaseHomTrainParkNCT05829915
mHealth Technology in People With Parkinson's Disease
A study testing ROXPro© system (A-Champs) and No exercise program in people with Parkinson Disease, run by Universidad Rey Juan Carlos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ROXPro© system (A-Champs) and No exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Efficacy of a Home Exercise Program Using mHealth Technology in People With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- ROXPro© system (A-Champs), No exercise program
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROXPro© system (A-Champs)Device
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.
No exercise programOther
The control group did not received the physical exercise program
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs) Receives: Device: ROXPro© system (A-Champs) |
| Control Group | Active comparator | Subjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy Receives: Other: No exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of gait at preferred pace
Speed (m/s)
Measured: baseline
Speed of gait at preferred pace
Speed (m/s)
Measured: at week 8
Cadence of gait at preferred pace
cadence (steps/min)
Measured: Baseline
Cadence of gait at preferred pace
cadence (steps/min)
Measured: At week 8
Step Length of gait at preferred pace
Step Length (m)
Measured: Baseline
Step Length of gait at preferred pace
Step Length (m)
Measured: At week 8
Secondary outcomes (2)
Time up & go test
Time (seconds)
Measured: Baseline
Time up & go test
Time (seconds)
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start30 Mar 2023
- Primary completion30 Jan 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Fernández del Olmo, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829915
- Sponsor's protocol ID
- 0801202000720
- Acronym
- HomTrainPark
- Status last verified
- Aug 2025
- First submitted
- 13 Apr 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villamil-Cabello E, Molinero-Martin E, Luque-Casado A, Fernandez-Del-Olmo MA. Home-Based time-constrained reactive training enhances movement speed in upper and lower limbs in Parkinson's disease: A randomized controlled trial. J Parkinsons Dis. 2026 Mar;16(2):298-307. doi: 10.1177/1877718X251405813. Epub 2026 Jan 30.
PubMed 41615860
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of a Home Exercise Program Using mHealth Technology in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05829915
- Acronym / sponsor ID
- HomTrainPark / 0801202000720
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: ROXPro© system (A-Champs)Subjects in the intervention group will perform 24 sessions of multisensory training using ROXPro© system (A-Champs) |
| Control Group | Active comparator | Other: No exercise programSubjects in the Control Group will not perform 24 sessions of multisensory training and they will keep doing the current therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention Group |
| No exercise programThe control group did not received the physical exercise program | Other | Control Group |
Primary outcome
Speed of gait at preferred pace
Time frame: baseline
Speed (m/s)
Speed of gait at preferred pace
Time frame: at week 8
Speed (m/s)
Cadence of gait at preferred pace
Time frame: Baseline
cadence (steps/min)
Cadence of gait at preferred pace
Time frame: At week 8
cadence (steps/min)
Step Length of gait at preferred pace
Time frame: Baseline
Step Length (m)
Step Length of gait at preferred pace
Time frame: At week 8
Step Length (m)
2 secondary outcomes
Time up & go test
Time frame: Baseline
Time up & go test
Time frame: At week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Derived from this study: PubMed 41615860Villamil-Cabello E, Molinero-Martin E, Luque-Casado A, Fernandez-Del-Olmo MA. Home-Based time-constrained reactive training enhances movement speed in upper and lower limbs in Parkinson's disease: A randomized controlled trial. J Parkinsons Dis. 2026 Mar;16(2):298-307. doi: 10.1177/1877718X251405813. Epub 2026 Jan 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROXPro© system (A-Champs) and No exercise program in people with Parkinson Disease, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of gait at preferred pace (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.