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

NCT07411365 | Not Yet Recruiting

• 1 other identifier: 2025-0681-BO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 \[3-7\]. 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).

Conditions

PARKINSON DISEASE (Disorder); Mild Cognitive Impairment (MCI)

Keywords

Dual task training; Parkinson's disease; Activities of daily living function; Hometraining

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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

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

Study Arms (2)

Dual-task Cognitive-Motor Training

EXPERIMENTAL

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.

Behavioral: Dual-task Cognitive Motor Training

Cognitive Motor Training

ACTIVE COMPARATOR

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

Behavioral: Cognitive Motor Training

Interventions

Dual-task Cognitive Motor Training BEHAVIORAL

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.

Dual-task Cognitive-Motor Training

Cognitive Motor Training BEHAVIORAL

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

Cognitive Motor Training

Eligibility Criteria

• Age: 51 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Parkinson Stiftung: collaborator

Study Sites (1)

University hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (13)

• [13] K.P. Pereira-Pedro, I.M. de Oliveira, I. Mollinedo-Cardalda, J.M. Cancela-Carral, 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 19(13) (2022).

  BACKGROUND

• [12] P.L. Wong, S.J. Cheng, Y.R. Yang, R.Y. Wang, Effects of Dual Task Training on Dual Task Gait Performance and Cognitive Function in Individuals With Parkinson Disease: A Meta-analysis and Meta-regression, Archives of physical medicine and rehabilitation 104(6) (2023) 950-964.

  BACKGROUND

• [11] H. Johansson, A.K. Folkerts, I. Hammarstrom, E. Kalbe, B. Leavy, Effects of motor-cognitive training on dual-task performance in people with Parkinson's disease: a systematic review and meta-analysis, J Neurol 270(6) (2023) 2890-2907.

  BACKGROUND

• [10] M. Schmitter-Edgecombe, C. McAlister, D. Greeley, 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 28(8) (2022) 798-809.

  BACKGROUND

• [9] T.E. Raffegeau, L.M. Krehbiel, N. Kang, F.J. Thijs, L.J.P. Altmann, J.H. Cauraugh, C.J. Hass, A meta-analysis: Parkinson's disease and dual-task walking, Parkinsonism Relat Disord 62 (2019) 28-35.

  BACKGROUND

• 8] S. Becker, M. Bode, K. Brockmann, T. Gasser, K. Michaelis, S. Solbrig, H.C. Nuerk, C. Schulte, W. Maetzler, M. Zimmermann, D. Berg, I. Liepelt-Scarfone, Cognitive-Driven Activities of Daily Living Impairment as a Predictor for Dementia in Parkinson Disease: A Longitudinal Cohort Study, Neurology (2022).

  BACKGROUND

• [7] S.C.F. van de Weijer, A.A. Duits, B.R. Bloem, N.M. de Vries, R.P.C. Kessels, S. Kohler, G. Tissingh, M.L. Kuijf, Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study, Eur Neurol 83(4) (2020) 426-432.

  BACKGROUND

• [6] B.J. Lawrence, N. Gasson, A.R. Johnson, L. Booth, A.M. Loftus, Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial, Parkinsons Dis 2018 (2018) 4318475.

  BACKGROUND

• [5] E. Fiorenzato, S. Zabberoni, M.S. De Simone, A. Costa, G. Tieri, S. Taglieri, A. Peppe, G.A. Carlesimo, C. Caltagirone, A. Antonini, G. Cona, Effects of virtual reality cognitive training on executive function and prospective memory in Parkinson's disease and healthy aging, J Neurol Sci 473 (2025) 123507.

  BACKGROUND

• [4] I. Leroi, S. Vatter, L.A. Carter, S.J. Smith, V. Orgeta, E. Poliakoff, M.A. Silverdale, J. Raw, D.J. Ahearn, C. Taylor, J. Rodda, T. Abdel-Ghany, S.A. McCormick, Parkinson's-adapted cognitive stimulation therapy: a pilot randomized controlled clinical trial, Ther Adv Neurol Disord 12 (2019) 1756286419852217.

  BACKGROUND

• [3] S. Tagliente, B. Minafra, S. Aresta, P. Santacesaria, A. Buccoliero, C. Palmirotta, G. Lagravinese, D. Mongelli, C. Gelao, L. Macchitella, S. Pazzi, D. Scrutinio, P. Baiardi, P. Battista, Effectiveness of a home-based computerized cognitive training in Parkinson's disease: a pilot randomized cross-over study, Frontiers in psychology 15 (2024) 1531688.

  BACKGROUND

• [2] R. van den Bergh, B.R. Bloem, M.J. Meinders, L.J.W. Evers, The state of telemedicine for persons with Parkinson's disease, Current opinion in neurology 34(4) (2021) 589-597.

  BACKGROUND

• [1] D. Peacock, P. Baumeister, A. Monaghan, J. Siever, J. Yoneda, D. Wile, Perception of Healthcare Access and Utility of Telehealth Among Parkinson's Disease Patients, Can J Neurol Sci 47(5) (2020) 700-704.

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Inga Liepelt-Scarfone, Prof. Dr.

CONTACT

+497071298ß424; Inga.Liepelt@uni-tuebingen.de

Merle Bode, MSc

CONTACT

+4970712980424; Merle.Bode@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: fter 1:1 randomization to either the experimental dual task cognitive-motor training (DCT) or the control motor training (CMT).

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: IPD will be available upon request
• Access Criteria: Data can be requested by the primary contact persons of this study

Locations

DE (1)