NCT05829915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

April 13, 2023

Last Update Submit

August 18, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

  • Speed of gait at preferred pace

    Speed (m/s)

    baseline

  • Speed of gait at preferred pace

    Speed (m/s)

    at week 8

  • Cadence of gait at preferred pace

    cadence (steps/min)

    Baseline

  • Cadence of gait at preferred pace

    cadence (steps/min)

    At week 8

  • Step Length of gait at preferred pace

    Step Length (m)

    Baseline

  • Step Length of gait at preferred pace

    Step Length (m)

    At week 8

Secondary Outcomes (2)

  • Time up & go test

    Baseline

  • Time up & go test

    At week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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

Other: No exercise program

Interventions

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.

Intervention Group
No exercise programOTHER

The control group did not received the physical exercise program

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Fuenlabrada, Madrid, 28942, Spain

Location

Related Publications (1)

  • 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 Jan 30:1877718X251405813. doi: 10.1177/1877718X251405813. Online ahead of print.

    PMID: 41615860DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 26, 2023

Study Start

March 30, 2023

Primary Completion

January 30, 2024

Study Completion

April 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)