NCT07094828

Brief Summary

Improving movement control during rehabilitation is still a challenge for people with Parkinson's Disease, mainly because of the motor symptoms caused by the condition. However, new technologies offer promising ways to support therapy. This clinical trial will test whether using TecnoBody® D-Wall technology integrated with two techniques (Action Observation and Motor Imagery) can improve physiotherapy outcomes for people with Parkinson's Disease. The TecnoBody® D-Wall is a type of digital mirror that includes a 3D camera, pressure-sensitive platforms, and a screen. It shows a person's body movements in real time and gives visual feedback on joint mobility, balance, and how weight is distributed during movement. Action Observation and Motor Imagery are two techniques already used in physiotherapy. Action Observation involves watching someone perform a movement, while Motor Imagery involves mentally rehearsing the movement before doing it. Studies have shown that both techniques activate the same brain areas involved in actual movement. In this trial, after watching and imagining the movement, participants will perform the exercise in front of the D-Wall. This setup gives them real-time feedback to help improve how they move, a new approach for these techniques. To see if this approach works, we will measure balance using a test validated for people with Parkinson's Disease and assess mobility using lab-based gait analysis, which tracks how a person walks. Participants in the study will:

  • Be receiving routine physiotherapy at a hospital that is specialized in Parkinson's Disease rehabilitation.
  • Be randomly assigned to one of two groups: 1) One group will receive physiotherapy incorporating the D-Wall alongside Action Observation and Motor Imagery; 2) The other group will receive physiotherapy incorporating the D-Wall but, without Action Observation or Motor Imagery.
  • Take part in therapy for up to four weeks, followed by another four weeks of monitoring, for a total of up to two months.
  • Complete some initial tests to check if they are eligible for the study. This study includes patients who have been diagnosed with idiopathic Parkinson's Disease and are undergoing rehabilitation as part of their usual hospital care. The intervention lasts as long as their regular hospital stay.

Trial Health

65
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Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 23, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

Action ObservationMotor ImageryTechnologyPhysiotherapyGait Analysis

Outcome Measures

Primary Outcomes (1)

  • Dynamic postural control

    The Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used to assess dynamic postural control.

    at baseline, at the fourth week (end of the intervention period), and at the eighth week (follow-up).

Secondary Outcomes (1)

  • Moviment analysis

    at baseline, at the fourth week (end of the intervention period), and at the eighth week (follow-up).

Study Arms (2)

Action Observation and Motor Imagery integrated with D-Wall technology

EXPERIMENTAL
Other: AOMI with D-Wall

Routine rehabilitative physiotherapy integrated with D-Wall technology

ACTIVE COMPARATOR
Other: Routine physiotherapy with D-Wall

Interventions

The intervention group will follow routine rehabilitative activity in the morning and will perform one hour of Action Observation and Motor Imagery training with augmented visual feedback (D-Wall) in the afternoon, three times a week. Each session will be conducted as follows: first AO (Action Observation), then MI (Motor Imagery). During the MI phase, participants will be asked to imagine the motor tasks and then perform them, receiving real-time augmented visual feedback provided by the digital mirror.

Also known as: Action Observation and Motor Imagery integrated with D-Wall technology
Action Observation and Motor Imagery integrated with D-Wall technology

The control group will also follow routine rehabilitative activity in the morning, while in the afternoon they will perform motor training of the same duration, without Action Observation and Motor Imagery, but solely with augmented visual feedback (D-Wall), with the same weekly frequency.

Also known as: Routine rehabilitative physiotherapy integrated with D-Wall technology
Routine rehabilitative physiotherapy integrated with D-Wall technology

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of idiopathic Parkinson's disease for at least 5 years;
  • stable medication regimen for at least 4 weeks;
  • no cognitive impairment according to the Mini-Mental State Examination;
  • at stage ≤3 on the Hoehn \& Yahr scale;
  • provide informed consent to participate.

You may not qualify if:

  • undergoing advanced therapies (e.g., deep brain stimulation or infusion pump therapy);
  • unable to walk independently for at least 5 meters without assistive devices;
  • substance abuse;
  • with visual, orthopedic, or other medical conditions that could hinder the execution of activities;
  • history of other neurological disorders (other than Parkinson's disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Inaihá L. Benincá, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Researcher in charge of Data Analysis
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07