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Parkinson DiseaseNCT05514379

Effect of Cognitive Training on Gait in Parkinson's Disease

A study testing cognitive training in people with Parkinson Disease, run by General University Hospital, Prague at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCzechia
Study dates
1 Oct 2022to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • General University Hospital in Prague

    Prague, 12821

Other trials in Czechia

About this study

Official title: Disorders of Gait, Postural Stability and Cognition in Parkinson's Disease: Presymptomatic Detection and Targeted Rehabilitation

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.

Read the 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.
Being tested
cognitive training
Keywords
Parkinson Disease, Cognitive training, Gait
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive trainingBehavioural

    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.

Study groups in NCT05514379
Study groupRoleWhat they receive
Group cognitive trainingExperimentalThe 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.
Receives: Behavioral: cognitive training
Home-based cognitive trainingActive comparatorThe 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.
Receives: Behavioral: cognitive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and 12 weeks

  2. 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

    Measured: Baseline and 12 weeks

Secondary outcomes (16)

  1. Timed Up and Go Test: single-task performance

    G-Walk instrumental gait assessment will be used

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

  2. 10-meter walking test: single-task performance

    G-Walk instrumental gait assessment will be used

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

  3. 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

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

  4. Number of steps/day

    Assessed using Fitbit activity trackers

    Measured: 5 days monitoring at baseline and 12 weeks

  5. The Montreal Cognitive Assessment (MoCA), Total score

    Global cognition screening

    Measured: Baseline, 12 weeks, 3 months follow-up

  6. Trail Making Test A (TMT A), Total score (in seconds)

    Assessing of attention distribution.

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

  7. 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

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

  8. 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

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

  9. Tower of London, Total score

    Assessing of executive functions - problem solving

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

  10. Depression, Anxiety and Stress Scale (DASS 21)

    Self-assessment scale of depression, anxiety and stress. Patient fills it at home.

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

  11. Falls Efficacy Scale-International

    Fear of falls assessment

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

  12. Number of falls

    Diary based quantification of the number of falls

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

  13. 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

    Measured: 12 weeks and 1 month follow-up

  14. 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

    Measured: 12 weeks and 3 months follow-up

  15. 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

    Measured: 12 weeks and 1 month follow-up

  16. 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

    Measured: 12 weeks and 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start1 Oct 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prticipants are randomly assigned to either the experimental or the control group.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514379
Sponsor's protocol ID
NU20-04-00327
Status last verified
Sep 2023
First submitted
15 Aug 2022
Last updated
14 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24322063

  • 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.

    PubMed 18058946

  • 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.

    PubMed 24132840

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

  • 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.

    PubMed 24531294

  • 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.

    PubMed 26381808

  • 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.

    PubMed 23328947

  • 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.

    PubMed 20445152

  • 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.

    PubMed 31539800

  • 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.

    PubMed 26308937

Questions about this trial

What is this clinical trial studying?

A study testing cognitive training in people with Parkinson Disease, run by General University Hospital, Prague at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline instrumental assessment of turn fluency during rapid turns at 12 weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514379, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.

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