Parkinson Disease
Conditions
Keywords
Parkinson Disease, Cognitive training, Gait
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.
Interventions
BEHAVIORALcognitive training
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.
Sponsors
Charles University, Czech Republic
General University Hospital, Prague
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants are blinded to study hypothesis. Investigators are blinded to treatment group.
Intervention model description
Prticipants are randomly assigned to either the experimental or the control group.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Number of steps/day | 5 days monitoring at baseline and 12 weeks | Assessed using Fitbit activity trackers |
| The Montreal Cognitive Assessment (MoCA), Total score | Baseline, 12 weeks, 3 months follow-up | Global cognition screening |
| 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. |
| 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 |
| 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 |
| 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 |
| Number of falls | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Diary based quantification of the number of falls |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trail Making Test B (TMT B): Total score (in seconds), Number of errors | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of executive functions - cognitive flexibility. |
| Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of focused auditory attention. |
| Digit Span Backward, Wechsler Adult Intelligence Scale-Revised, Total score | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Working memory capacity measurement. |
| Digit Symbol, Wechsler Adult Intelligence Scale-Revised, Total score | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of divided attention and working memory. |
| Counting: number of (correct) answers per second | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Patient is asked to subtract 3 from a random number between 51-100 while seated. This assessment is used as a reference value for TUG-DT and 10MWT-DT |
| MDS-Unified Parkinson's Disease Rating Scale | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Scale evaluating various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. |
| Freezing of Gait Questionnaire | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Subjective evaluation of freezing of gait |
| Quantitative MRI metrics | Baseline | Volumetric parameters |
| Grooved Pegboard, Left. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of visual-motor coordination. The Grooved Pegboard is a manipulative dexterity test consisting of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. |
| The Parkinson´s Disease Questionnaire (PDQ-39) | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Self-assessment quality of life scale for patients with Parkinson's disease. Patient fills it at home. |
| Grooved Pegboard, Right. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of visual-motor coordination. The Grooved Pegboard is a manipulative dexterity test consisting of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. |
| Exploratory assessment of relationship between clinical effects of cognitive training and blood signature of polymorphisms in PD-related genes | Baseline | Custom genetic panel (SureSelect, Agilent) for mutational analysis of 177 genes (including APOE, MAPT, GBA LRRK2, etc.) |
| Phonemic Verbal Fluency FAS, letters: K, P, S Letter K, Total score Letter P, Total Score Letter S, Total score Letters K, P, S, Total score | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of executive functions - initation, maintenance, stop and end the activity |
| Auditory Verbal Learning Test (AVLT): T1 (Try) T2 T3 T4 T5 T1-5 Total score Interfence, Total score T6, Total score Delayed recall, Total score Recognition, Correct answers total score, False answers total score | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of auditory memory, memory capacity, ability to learn, delayed recall, recognition |
| Semantic Fluency, category: Animals, Total score | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up | Assessing of phatic functions. |
Countries
Czechia
Outcome results
None listed