NCT07411365Not yet recruiting

Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI

Efficacy of Dual-task Telerehabilitation to Prevent Worsening in Activities of Daily Living in People With Parkinson's Disease at High Risk for Dementia: A Proof-of-concept Study

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

Telerehabilitation is a promising tool for treating and preventing further disease progression in Parkinson's disease (PD) \[1, 2\]. First studies in people with PD (PwPD) verified the feasibility of home-based digital cognitive training \[3-7\]. Progression in cognitive impairment and the onset and worsening of problems with complex everyday tasks are hallmarks of the prodromal phase of Parkinson's disease dementia (PDD). Consequently, the risk of PDD conversion is dramatically increased for PwPD with both mild cognitive impairment (PD-MCI) and complex activities of daily living (ADL) problems related to cognitive impairment \[8\]. Therefore, this group may be a promising target group for interventions, as they are at risk for serious and rapidly progressive cognitive deterioration. PwPD with PD-MCI show deficits in motor-cognition \[9\] and attentional-control, both of which affect ADL \[10\]. Dual-task cognitive trainings (DCT) shows great potential to lower down the disease process \[11, 12\], but so far no home-based DCT with the primary endpoint of complex ADL and cognition has been conducted in PwPD. We adapted an on-site DCT to improve both physical and cognitive function in PwPD \[13\]. The training will be conducted as a telerehabilitation training in PwPD with PD-MCI and cognitive ADL impairment, identified with the Functional Activities Questionnaire (FAQ). Of PwPD with PD-MCI who have more cognitive rather than motor associated ADL dysfunction (reflected by a value of the FAQ quotient \> 1.008), nearly 50% develop dementia (PDD) within three years \[8\]. In our single-center randomized, controlled non-pharmacological intervention, 42 PwPD with PD-MCI and FAQ quotient \>1.008 will be assessed with pre-(T0) and post(T1), 6-months (T2) and 12-month follow-up (T3) testing. After 1:1 randomization to either the experimental DCT or the control motor training (CMT), both groups will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes. While cycling, the DCT group will additionally perform digital cognitive training on a tablet, covering attention, working memory and executive function. The cognitive training will automatically adapt to performance levels and is remotely accessible. The training is aimed to enhance cognition as well as ADL and to prevent its further decline, with an emphasis on maintaining ADLs in the prodromal stage of Parkinson's disease dementia (PDD).

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 42 (estimated)
First submitted: 5 Jan 2026
Start date: 1 Mar 2026
Primary completion date: 31 Aug 2027
Lead sponsor: University Hospital Tuebingen
Diseases: Parkinson disease
NCT number: NCT07411365

What you commit to

Study type: Interventional
Planned participants: 42
From 1 Mar 2026 to the primary completion date, 31 Aug 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Alcohol, medication, or drug dependency or abuse (except for nicotine)
Participation in any clinical investigation of a new compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations

Other illness

Intake of anti-dementia drugs
History of brain disease other than PD (e.g. head trauma, stroke, encephalitis) also including muscular diseases (e.g. myestenia gravis or myopathy)
Pre-existing condition that limits limb movement (e.g. muscular injuries, knee and hip disorders
severe cardiovascular diseases with heart failure
severe respiratory diseases (e.g. asthma and lung disease)
severe other accompanying illnesses with impairment of lung function
renal insufficiency
acute stage of infectious disease
acute stage of cancer
other disease with pronounced physical weakness
History of brain disease other than PD, e.g., head trauma, stroke, encephalitis
Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study

Other

Diagnosis of PDD
Deep brain stimulation
Signs of severe depression indicated by either the 15 item version Geriatric Depression Scale (≥ 5 points)
Acute psychosis
Any disability or issues that may prevent the subject from completing the informed consent form or other study requirements

Who the study is looking for

PD diagnosis confirmed by a neurologist
PD diagnosis at least for one year
Age between 51-80 years
German as their mother tongue
Diagnosis of PD-MCI according to the Level II criteria of the Movement Disorder Society
Cognitive ADL impairment as defined by the FAQ quotient
An informant who has given consent to provide information about the participant's activities of daily living (ADLs) and who lives in the participant's home.
Access to a WIFI Network at home
Unimpaired or corrected vision and hearing
Appropriate text comprehension and reading ability
Ability to communicate well with the investigator, to understand and comply with the requirements of the study
Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care

Age in the registry: 51 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University Hospital Tübingen Coordinator of this site? Confirm its status	Tübingen	Germany	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.