Effect of Cognitive Training on Gait in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: cognitive training
- Registration Number
- NCT05514379
- Lead Sponsor
- General University Hospital, Prague
- Brief Summary
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
* 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group cognitive training cognitive training 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. Home-based cognitive training cognitive training 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.
- Primary Outcome Measures
Name Time Method Change from Baseline instrumental assessment of turn fluency during rapid turns at 12 weeks Baseline and 12 weeks see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
Change from Baseline Timed Up and Go Test: dual-task performance at 12 weeks Baseline and 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
- Secondary Outcome Measures
Name Time Method Change from post-intervention Timed Up and Go Test: dual-task performance at 3 months follow-up 12 weeks and 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
Number of steps/day 5 days monitoring at baseline and 12 weeks Assessed using Fitbit activity trackers
The Victoria Version of Stroop Test (VST): Color Word Time Score (in seconds) Error score on VST Color Word Task, Total score Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Assessing of executive functions - inhibition
Trail Making Test A (TMT A), Total score (in seconds) Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Assessing of attention distribution.
Change from post-intervention instrumental assessment of turn fluency during rapid turns at 3 months follow-up 12 weeks and 3 months follow-up see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
Change from post-intervention Timed Up and Go Test: dual-task performance at 1 month follow-up 12 weeks and 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
Timed Up and Go Test: single-task performance Baseline, 12 weeks, 1 month follow-up, 3 months follow-up G-Walk instrumental gait assessment will be used
10-meter walking test: dual-task performance Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Patient is asked to perform 10MWT while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
The Montreal Cognitive Assessment (MoCA), Total score Baseline, 12 weeks, 3 months follow-up Global cognition screening
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) Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Assessing of focused visual attention
Number of falls Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Diary based quantification of the number of falls
10-meter walking test: single-task performance Baseline, 12 weeks, 1 month follow-up, 3 months follow-up G-Walk instrumental gait assessment will be used
Tower of London, Total score Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Assessing of executive functions - problem solving
Depression, Anxiety and Stress Scale (DASS 21) Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Self-assessment scale of depression, anxiety and stress. Patient fills it at home.
Falls Efficacy Scale-International Baseline, 12 weeks, 1 month follow-up, 3 months follow-up Fear of falls assessment
Change from post-intervention instrumental assessment of turn fluency during rapid turns at 1 month follow-up 12 weeks and 1 month follow-up see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
Trial Locations
- Locations (1)
General University Hospital in Prague
🇨🇿Prague, Czechia