Effect of Cognitive Training on Gait in Parkinson's Disease

NCT05514379 | Unknown

• 1 other identifier: NU20-04-00327
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Cognitive training; Gait

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (16)

• Timed Up and Go Test: single-task performance

  Baseline, 12 weeks, 1 month follow-up, 3 months follow-up

• 10-meter walking test: single-task performance

  Baseline, 12 weeks, 1 month follow-up, 3 months follow-up

• 10-meter walking test: dual-task performance

  Baseline, 12 weeks, 1 month follow-up, 3 months follow-up

• Number of steps/day

  5 days monitoring at baseline and 12 weeks

• The Montreal Cognitive Assessment (MoCA), Total score

  Baseline, 12 weeks, 3 months follow-up

Other Outcomes (17)

• Counting: number of (correct) answers per second

  Baseline, 12 weeks, 1 month follow-up, 3 months follow-up

• MDS-Unified Parkinson's Disease Rating Scale

  Baseline, 12 weeks, 1 month follow-up, 3 months follow-up

• Freezing of Gait Questionnaire

  Baseline, 12 weeks, 1 month follow-up, 3 months follow-up

Study Arms (2)

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.

Behavioral: cognitive training

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.

Behavioral: cognitive training

Interventions

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.

Group cognitive training; Home-based cognitive training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead
• Charles University, Czech Republic: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, 12821, Czechia

Location

Related Publications (10)

• 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.

  PMID: 24322063 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.

  PMID: 18058946 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.

  PMID: 24132840 BACKGROUND

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

  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.

  PMID: 24531294 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.

  PMID: 26381808 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.

  PMID: 23328947 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.

  PMID: 20445152 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.

  PMID: 31539800 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.

  PMID: 26308937 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Evzen Ruzicka, Prof.

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants are blinded to study hypothesis. Investigators are blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Evzen Ruzicka, MD, DSc.

Model Details: Prticipants are randomly assigned to either the experimental or the control group.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 24, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)