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PARKINSON DISEASE (Disorder)HomeFitPDNCT07411365

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

A study testing Dual-task Cognitive Motor Training and Cognitive Motor Training in people with PARKINSON DISEASE (Disorder) and Mild Cognitive Impairment (MCI), run by University Hospital Tuebingen at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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]. Read more about this study

Who is it for?
Ages 51 to 80 years
What is being tested?
Dual-task Cognitive Motor Training and Cognitive Motor Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteGermany
Study dates
1 Mar 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 51 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Diagnosis of PDD
  • Intake of anti-dementia drugs
  • Deep brain stimulation
  • 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
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  • 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
  • Alcohol, medication, or drug dependency or abuse (except for nicotine)
  • 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
  • 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
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Inga Liepelt-Scarfone, Prof. Dr. contact

+497071298ß424

Inga.Liepelt@uni-tuebingen.de

Germany1 site
  • University hospital Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

Official title: 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

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).

Being tested
Dual-task Cognitive Motor Training, Cognitive Motor Training
Keywords
Dual task training, Parkinson's disease, Activities of daily living function, Hometraining
Medical subject headings
Parkinson Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual-task Cognitive Motor TrainingBehavioural

    Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30. 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.

  • Cognitive Motor TrainingBehavioural

    Persons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30.

Study groups in NCT07411365
Study groupRoleWhat they receive
Dual-task Cognitive-Motor TrainingExperimentalPersons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30. 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.
Receives: Behavioral: Dual-task Cognitive Motor Training
Cognitive Motor TrainingActive comparatorPersons will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes.
Receives: Behavioral: Cognitive Motor Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Informant rated cognition score of the Functional Activity Questionnaire (FAQ)

    Values ranged from 0 to 12 points, with higher values indicating more severe cognitive ADL impairment

    Measured: Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3)

  2. Auditory Stroop Test

    Auditory word were presented in high and low pitch, reaction time for classifying the high and low pitch not the word spoken is registered over 20 trials

    Measured: Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
fter 1:1 randomization to either the experimental dual task cognitive-motor training (DCT) or the control motor training (CMT).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07411365
Sponsor's protocol ID
2025-0681-BO
Other IDs
2025-0681-BO
Acronym
HomeFitPD
Status last verified
Feb 2026
First submitted
5 Jan 2026
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data sharing with other researchers requiere the permission of our ethic committee and a data transfer agreement

Publications

  • Pereira-Pedro KP, de Oliveira IM, Mollinedo-Cardalda I, Cancela-Carral JM. Effects of Cycling Dual-Task on Cognitive and Physical Function in Parkinson's Disease: A Randomized Double-Blind Pilot Study. Int J Environ Res Public Health. 2022 Jun 26;19(13):7847. doi: 10.3390/ijerph19137847.

    PubMed 35805505
  • Wong PL, Cheng SJ, Yang YR, Wang RY. Effects of Dual Task Training on Dual Task Gait Performance and Cognitive Function in Individuals With Parkinson Disease: A Meta-analysis and Meta-regression. Arch Phys Med Rehabil. 2023 Jun;104(6):950-964. doi: 10.1016/j.apmr.2022.11.001. Epub 2022 Nov 28.

    PubMed 36574531
  • Johansson H, Folkerts AK, Hammarstrom I, Kalbe E, Leavy B. Effects of motor-cognitive training on dual-task performance in people with Parkinson's disease: a systematic review and meta-analysis. J Neurol. 2023 Jun;270(6):2890-2907. doi: 10.1007/s00415-023-11610-8. Epub 2023 Feb 23.

    PubMed 36820916
  • Schmitter-Edgecombe M, McAlister C, Greeley D. A Comparison of Functional Abilities in Individuals with Mild Cognitive Impairment and Parkinson's Disease with Mild Cognitive Impairment Using Multiple Assessment Methods. J Int Neuropsychol Soc. 2022 Sep;28(8):798-809. doi: 10.1017/S1355617721001077. Epub 2021 Sep 6.

    PubMed 34486508
  • Raffegeau TE, Krehbiel LM, Kang N, Thijs FJ, Altmann LJP, Cauraugh JH, Hass CJ. A meta-analysis: Parkinson's disease and dual-task walking. Parkinsonism Relat Disord. 2019 May;62:28-35. doi: 10.1016/j.parkreldis.2018.12.012. Epub 2018 Dec 12.

    PubMed 30594454
  • Becker S, Bode M, Brockmann K, Gasser T, Michaelis K, Solbrig S, Nuerk HC, Schulte C, Maetzler W, Zimmermann M, Berg D, Liepelt-Scarfone I. Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study. Neurology. 2022 Dec 5;99(23):e2548-e2560. doi: 10.1212/WNL.0000000000201201.

    PubMed 36240089
  • van de Weijer SCF, Duits AA, Bloem BR, de Vries NM, Kessels RPC, Kohler S, Tissingh G, Kuijf ML. Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study. Eur Neurol. 2020;83(4):426-432. doi: 10.1159/000509685. Epub 2020 Aug 5.

    PubMed 32756067
  • Lawrence BJ, Gasson N, Johnson AR, Booth L, Loftus AM. Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial. Parkinsons Dis. 2018 Mar 26;2018:4318475. doi: 10.1155/2018/4318475. eCollection 2018.

    PubMed 29780572
  • Fiorenzato E, Zabberoni S, De Simone MS, Costa A, Tieri G, Taglieri S, Peppe A, Carlesimo GA, Caltagirone C, Antonini A, Cona G. Effects of virtual reality cognitive training on executive function and prospective memory in Parkinson's disease and healthy aging. J Neurol Sci. 2025 Jun 15;473:123507. doi: 10.1016/j.jns.2025.123507. Epub 2025 Apr 14.

    PubMed 40250092
  • Leroi I, Vatter S, Carter LA, Smith SJ, Orgeta V, Poliakoff E, Silverdale MA, Raw J, Ahearn DJ, Taylor C, Rodda J, Abdel-Ghany T, McCormick SA. Parkinson's-adapted cognitive stimulation therapy: a pilot randomized controlled clinical trial. Ther Adv Neurol Disord. 2019 Jul 4;12:1756286419852217. doi: 10.1177/1756286419852217. eCollection 2019.

    PubMed 31320931
  • Tagliente S, Minafra B, Aresta S, Santacesaria P, Buccoliero A, Palmirotta C, Lagravinese G, Mongelli D, Gelao C, Macchitella L, Pazzi S, Scrutinio D, Baiardi P, Battista P. Effectiveness of a home-based computerized cognitive training in Parkinson's disease: a pilot randomized cross-over study. Front Psychol. 2025 Jan 9;15:1531688. doi: 10.3389/fpsyg.2024.1531688. eCollection 2024.

    PubMed 39850970
  • van den Bergh R, Bloem BR, Meinders MJ, Evers LJW. The state of telemedicine for persons with Parkinson's disease. Curr Opin Neurol. 2021 Aug 1;34(4):589-597. doi: 10.1097/WCO.0000000000000953.

    PubMed 33990100
  • Peacock D, Baumeister P, Monaghan A, Siever J, Yoneda J, Wile D. Perception of Healthcare Access and Utility of Telehealth Among Parkinson's Disease Patients. Can J Neurol Sci. 2020 Sep;47(5):700-704. doi: 10.1017/cjn.2020.99. Epub 2020 May 26.

    PubMed 32450924

Questions about this trial

What is this clinical trial studying?

A study testing Dual-task Cognitive Motor Training and Cognitive Motor Training in people with PARKINSON DISEASE (Disorder) and Mild Cognitive Impairment (MCI), run by University Hospital Tuebingen at 1 site in Germany.

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 12 inclusion and 19 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: opening soon, as of the sponsor's last update on 19 Feb 2026. 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Inga Liepelt-Scarfone, Prof. Dr. (+497071298ß424, Inga.Liepelt@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Informant rated cognition score of the Functional Activity Questionnaire (FAQ) (time frame: Outcome will be assessed before randomization, after 8 weeks training (T1), six months after (T2) and 12 months after enrollment (T3)). The study lists 2 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 NCT07411365, which also lists 13 linked publications.

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 19 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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