Skip to main content
Clinical Trials/NCT07411365
NCT07411365
Not yet recruiting
Not Applicable

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

University Hospital Tuebingen1 site in 1 country42 target enrollmentStarted: March 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
42
Locations
1
Primary Endpoint
Informant rated cognition score of the Functional Activity Questionnaire (FAQ)

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
51 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Dual-task Cognitive Motor Training (Behavioral)

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.

Intervention: Cognitive Motor Training (Behavioral)

Outcomes

Primary Outcomes

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)

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

Auditory Stroop Test

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials