Effect of Cognitive Training on Gait in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Disorders of Gait, Postural Stability and Cognition in Parkinson's Disease: Presymptomatic Detection and Targeted Rehabilitation

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Parkinson´s disease (PD) PD duration ≥8 years mild cognitive impairment stable medication presence of freezing of gait according to the FoG-Q AND/OR Rapid Turns Test Exclusion Criteria: dementia deep brain stimulation, pump therapy with Duodopa or Apomorphine severe fluctuations with ON state duration for less than 2 hours dopa dysregulation syndrome impulse control disorder untreated depression benzodiazepines except for single dose at night non-compliance inability to walk without support significant co-morbidities likely to affect gait, e.g., acute illness, orthopedic disease, significant visual problems, or a clinical history of stroke involvement in other treatment trials not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prticipants are randomly assigned to either the experimental or the control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group cognitive training<br>The experimental group will undergo 60 minutes long cognitive training group sessions twice a week for 12 weeks focused on executive function, attention and working memory. | Behavioral: cognitive training<br>* 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.<br>|
| Active Comparator: Home-based cognitive training<br>The control group will perform executive function, attention and working memory training similar to the experimental group but at home as instructed by their therapist using specialized software for cognitive training (Rehacom). This training will be dose matched to the experimental group, i.e. it will be performed four times a week for 30 minutes for 12 weeks. In this group, therapists will only provide coaching once a month. | Behavioral: cognitive training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go Test: single-task performance | G-Walk instrumental gait assessment will be used | 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 | 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 | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | 
| Number of steps/day | Assessed using Fitbit activity trackers | 5 days monitoring at baseline and 12 weeks | 
| The Montreal Cognitive Assessment (MoCA), Total score | Global cognition screening | Baseline, 12 weeks, 3 months follow-up | 
| Trail Making Test A (TMT A), Total score (in seconds) | Assessing of attention distribution. | 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 | 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 | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | 
| Tower of London, Total score | Assessing of executive functions - problem solving | 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. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | 
| Falls Efficacy Scale-International | Fear of falls assessment | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | 
| Number of falls | Diary based quantification of the number of falls | 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 | 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 | 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 | 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 | 12 weeks and 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Parkinson Disease, Cognitive training