Clinical trial NCT05514379: Effect of Cognitive Training on Gait in Parkinson's Disease
Official title: Disorders of Gait, Postural Stability and Cognition in Parkinson's Disease: Presymptomatic Detection and Targeted Rehabilitation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Cognitive training
Gait
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
First posted: 2022-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prticipants are randomly assigned to either the experimental or the control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline instrumental assessment of turn fluency during rapid turns at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline Timed Up and Go Test: dual-task performance at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Timed Up and Go Test: single-task performance
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: 10-meter walking test: single-task performance
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: 10-meter walking test: dual-task performance
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Number of steps/day
timeFrame: 5 days monitoring at baseline and 12 weeks
measure: The Montreal Cognitive Assessment (MoCA), Total score
timeFrame: Baseline, 12 weeks, 3 months follow-up
measure: Trail Making Test A (TMT A), Total score (in seconds)
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: 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)
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: The Victoria Version of Stroop Test (VST): Color Word Time Score (in seconds) Error score on VST Color Word Task, Total score
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Tower of London, Total score
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Depression, Anxiety and Stress Scale (DASS 21)
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Falls Efficacy Scale-International
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Number of falls
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Change from post-intervention instrumental assessment of turn fluency during rapid turns at 1 month follow-up
timeFrame: 12 weeks and 1 month follow-up
measure: Change from post-intervention instrumental assessment of turn fluency during rapid turns at 3 months follow-up
timeFrame: 12 weeks and 3 months follow-up
measure: Change from post-intervention Timed Up and Go Test: dual-task performance at 1 month follow-up
timeFrame: 12 weeks and 1 month follow-up
measure: Change from post-intervention Timed Up and Go Test: dual-task performance at 3 months follow-up
timeFrame: 12 weeks and 3 months follow-up
Other outcomes:
measure: Counting: number of (correct) answers per second
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: MDS-Unified Parkinson's Disease Rating Scale
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Freezing of Gait Questionnaire
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Quantitative MRI metrics
timeFrame: Baseline
measure: Quantitative MRI metrics
timeFrame: Baseline
measure: Quantitative MRI metrics
timeFrame: Baseline
measure: 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
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: 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
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Semantic Fluency, category: Animals, Total score
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Trail Making Test B (TMT B): Total score (in seconds), Number of errors
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Digit Span Backward, Wechsler Adult Intelligence Scale-Revised, Total score
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Digit Symbol, Wechsler Adult Intelligence Scale-Revised, Total score
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Grooved Pegboard, Left.
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: The Parkinson´s Disease Questionnaire (PDQ-39)
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Grooved Pegboard, Right.
timeFrame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
measure: Exploratory assessment of relationship between clinical effects of cognitive training and blood signature of polymorphisms in PD-related genes
timeFrame: Baseline
Locations:
city: Prague
country: Czechia
facility: General University Hospital in Prague
Study officials:
affiliation: General University Hospital, Prague
name: Evzen Ruzicka, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Keus SHJ MM, Graziano M, et al. European Physiotherapy Guideline for Parkinson´s Disease. the Netherlands: KNGF/ParkinsonNet,2014.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.