Effect of Cognitive Training on Gait in Parkinson's Disease

NCT ID: NCT05514379

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 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.

Group Type: EXPERIMENTAL

cognitive training

Intervention Type: 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.

Home-based 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.

Group Type: ACTIVE_COMPARATOR

cognitive training

Intervention Type: 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.

Interventions

cognitive 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: collaborator

General University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Evžen Růžička

Prof. Evzen Ruzicka, MD, DSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evzen Ruzicka, Prof.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital, Prague

Locations

General University Hospital in Prague

Prague, , Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 18058946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24132840 (View on PubMed)

Keus SHJ MM, Graziano M, et al. European Physiotherapy Guideline for Parkinson´s Disease. the Netherlands: KNGF/ParkinsonNet,2014.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 24322063 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24531294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26381808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23328947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20445152 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31539800 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26308937 (View on PubMed)

Other Identifiers

NU20-04-00327

Identifier Type: -

Identifier Source: org_study_id