Physiotherapy and targeted rehabilitation are routinely performed in order to influence disorders of posture, gait and stability in Parkinson´s disease (PD), but their effects have been controversial (Keus et al. 2014; Walton wt al. 2014). Recently, several studies suggested that cognitive training can improve gait in patients with PD (Peterson et al. 2016, Heremans et al. 2013), similar to the effects seen in the elderly (Yogev-Seligmann et al. 2008; Amboni et al. 2013). Specific training programs including dual tasking with automatic verbal series, counting etc. have led to increased walking speed and improved stepping cadence, length, and duration in patients with dementia (Schwenk et al. 2010). However, since in advanced PD patients dual-task gait training has to be supervised by therapists, it is not a suitable type of therapy to be performed at home. Therefore, this study aims to verify and extend the encouraging results of the single study which showed a positive effect of cognitive function training on gait in PD (Milman et al. 2014) by exploring this effect in advanced PD patients, by assessing the effect on gait using more targeted clinical and instrumental evaluation, and by comparing two modes of therapy delivery, group and computer-based.
* Background: In a pilot study, Milman et al. 2014 showed that computer-based cognitive training focusing on executive function and attention performed at home might improve selected gait parameters in early patients with Parkinson´s disease (PD). * Goal 1: To explore this effect in advanced PD patients * Hypothesis 1: Effect of cognitive training focusing on executive function and attention will be detected also in advanced PD patients and this effect will be larger as compared to the results published by Milman et al. 2014. * Goal 2: To verify the results published by Milman et al. 2014 using more targeted clinical and instrumental gait assessment, including dual-task gait evaluation as well as instrumental testing of turn fluency (Bertoli et al. 2019). * Hypothesis 2: The results published by Milman et al. 2014 will be confirmed and an effect on dual-task gait and turn fluency will be shown. * Goal 3: To explore the role of the form of therapy setting, i.e. whether group setting might increase the effect of cognitive training on gait as compared to individual cognitive training at home. Such results have been shown in the case of a physiotherapy intervention by King et al. 2015. * Hypothesis 3: The effect of group cognitive training on gait will be larger as compared to individual dose-matched, computer-based cognitive training performed at home. However, it remains to be determined whether the effect size difference between the two groups will outweigh the advantages of tele-rehabilitation. * Design: Randomised-controlled trial * Interventions: experimental group: group cognitive training focusing on executive function and attention; control group: computer-based cognitive training focusing on executive function and attention performed at home. Intervention in both groups will be dose-matched (experimental: 60 mins, 2x/week, 12 weeks; control: 30 mins, 4x/week, 12 weeks) * Follow-up: at 1 and 3 months time points. * Power analysis results: at least 38 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Cognitive training focused on executive function, attention and working memory delivered either by the therapist in a group setting (experimental group) or by a specialized software for cognitive training (Rehacom) at home.
General University Hospital in Prague
Prague, Czechia
Change from Baseline instrumental assessment of turn fluency during rapid turns at 12 weeks
see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
Time frame: Baseline and 12 weeks
Change from Baseline Timed Up and Go Test: dual-task performance at 12 weeks
Patient is asked to perform TUG while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
Time frame: Baseline and 12 weeks
Timed Up and Go Test: single-task performance
G-Walk instrumental gait assessment will be used
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
10-meter walking test: single-task performance
G-Walk instrumental gait assessment will be used
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
10-meter walking test: dual-task performance
Patient is asked to perform 10MWT while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
Number of steps/day
Assessed using Fitbit activity trackers
Time frame: 5 days monitoring at baseline and 12 weeks
The Montreal Cognitive Assessment (MoCA), Total score
Global cognition screening
Time frame: Baseline, 12 weeks, 3 months follow-up
Trail Making Test A (TMT A), Total score (in seconds)
Assessing of attention distribution.
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
The Victoria Version of Stroop Test (VST): Dot Time Score (in seconds) Neutral Word Time Score (in seconds) The Victoria Version of Stroop Test (VST): Dot Time Score (in seconds) Neutral Word Time Score (in seconds)
Assessing of focused visual attention
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
The Victoria Version of Stroop Test (VST): Color Word Time Score (in seconds) Error score on VST Color Word Task, Total score
Assessing of executive functions - inhibition
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
Tower of London, Total score
Assessing of executive functions - problem solving
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
Depression, Anxiety and Stress Scale (DASS 21)
Self-assessment scale of depression, anxiety and stress. Patient fills it at home.
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
Falls Efficacy Scale-International
Fear of falls assessment
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
Number of falls
Diary based quantification of the number of falls
Time frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
Change from post-intervention instrumental assessment of turn fluency during rapid turns at 1 month follow-up
see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
Time frame: 12 weeks and 1 month follow-up
Change from post-intervention instrumental assessment of turn fluency during rapid turns at 3 months follow-up
see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
Time frame: 12 weeks and 3 months follow-up
Change from post-intervention Timed Up and Go Test: dual-task performance at 1 month follow-up
Patient is asked to perform TUG while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
Time frame: 12 weeks and 1 month follow-up
Change from post-intervention Timed Up and Go Test: dual-task performance at 3 months follow-up
Patient is asked to perform TUG while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
Time frame: 12 weeks and 3 months follow-up
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