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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group cognitive training | Experimental | 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. |
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| Home-based cognitive training | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive training | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Counting: number of (correct) answers per second | 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 | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| MDS-Unified Parkinson's Disease Rating Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evzen Ruzicka, Prof. | General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital in Prague | Prague | 12821 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24322063 | Background | Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321. | |
| 18058946 | Background | Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Prticipants are randomly assigned to either the experimental or the control group.
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Participants are blinded to study hypothesis. Investigators are blinded to treatment group.
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 |
Scale evaluating various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. |
| Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Freezing of Gait Questionnaire | Subjective evaluation of freezing of gait | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Quantitative MRI metrics | Volumetric parameters | Baseline |
| Quantitative MRI metrics | Vascular white matter lesional volume | Baseline |
| Quantitative MRI metrics | Resting functional connectivity | Baseline |
| 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 | Assessing of auditory memory, memory capacity, ability to learn, delayed recall, recognition | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| 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 | Assessing of executive functions - initation, maintenance, stop and end the activity | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Semantic Fluency, category: Animals, Total score | Assessing of phatic functions. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Trail Making Test B (TMT B): Total score (in seconds), Number of errors | Assessing of executive functions - cognitive flexibility. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score | Assessing of focused auditory attention. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Digit Span Backward, Wechsler Adult Intelligence Scale-Revised, Total score | Working memory capacity measurement. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Digit Symbol, Wechsler Adult Intelligence Scale-Revised, Total score | Assessing of divided attention and working memory. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Grooved Pegboard, Left. | 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. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| The Parkinson“s Disease Questionnaire (PDQ-39) | Self-assessment quality of life scale for patients with Parkinson's disease. Patient fills it at home. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Grooved Pegboard, Right. | 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. | Baseline, 12 weeks, 1 month follow-up, 3 months follow-up |
| Exploratory assessment of relationship between clinical effects of cognitive training and blood signature of polymorphisms in PD-related genes | Custom genetic panel (SureSelect, Agilent) for mutational analysis of 177 genes (including APOE, MAPT, GBA LRRK2, etc.) | Baseline |
| 24132840 | Background | Amboni M, Barone P, Hausdorff JM. Cognitive contributions to gait and falls: evidence and implications. Mov Disord. 2013 Sep 15;28(11):1520-33. doi: 10.1002/mds.25674. |
| Background | Keus SHJ MM, Graziano M, et al. European Physiotherapy Guideline for Parkinson“s Disease. the Netherlands: KNGF/ParkinsonNet,2014. |
| 24531294 | Background | Walton CC, Shine JM, Mowszowski L, Naismith SL, Lewis SJ. Freezing of gait in Parkinson's disease: current treatments and the potential role for cognitive training. Restor Neurol Neurosci. 2014;32(3):411-22. doi: 10.3233/RNN-130370. |
| 26381808 | Background | Peterson DS, King LA, Cohen RG, Horak FB. Cognitive Contributions to Freezing of Gait in Parkinson Disease: Implications for Physical Rehabilitation. Phys Ther. 2016 May;96(5):659-70. doi: 10.2522/ptj.20140603. Epub 2015 Sep 17. |
| 23328947 | Background | Heremans E, Nieuwboer A, Spildooren J, Vandenbossche J, Deroost N, Soetens E, Kerckhofs E, Vercruysse S. Cognitive aspects of freezing of gait in Parkinson's disease: a challenge for rehabilitation. J Neural Transm (Vienna). 2013 Apr;120(4):543-57. doi: 10.1007/s00702-012-0964-y. Epub 2013 Jan 18. |
| 20445152 | Background | Schwenk M, Zieschang T, Oster P, Hauer K. Dual-task performances can be improved in patients with dementia: a randomized controlled trial. Neurology. 2010 Jun 15;74(24):1961-8. doi: 10.1212/WNL.0b013e3181e39696. Epub 2010 May 5. |
| 31539800 | Background | Bertoli M, Croce UD, Cereatti A, Mancini M. Objective measures to investigate turning impairments and freezing of gait in people with Parkinson's disease. Gait Posture. 2019 Oct;74:187-193. doi: 10.1016/j.gaitpost.2019.09.001. Epub 2019 Sep 5. |
| 26308937 | Background | King LA, Wilhelm J, Chen Y, Blehm R, Nutt J, Chen Z, Serdar A, Horak FB. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. J Neurol Phys Ther. 2015 Oct;39(4):204-12. doi: 10.1097/NPT.0000000000000101. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |