Dual-Task Balance and Gait Training Combined With Cognitive Training in Parkinson's Patients

NCT ID: NCT07213232

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2026-03-03

Brief Summary

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The aim of the study is to examine the effects of a structured, cognitive dimension-specific cognitive training combined with dual-task balance and gait training on balance, gait, and cognition in individuals with Parkinson's disease.

Detailed Description

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Parkinson's disease (PD) is the most common movement disorder and the second most prevalent neurodegenerative disease after Alzheimer's disease. In addition to cardinal motor symptoms such as bradykinesia, rigidity, and resting tremor, PD is associated with a wide spectrum of non-motor symptoms that substantially increase overall disease burden. Among these, cognitive impairment is particularly significant, occurring up to six times more frequently in individuals with PD compared to the healthy population.

Although research on cognition in PD has increased over the past two decades, knowledge and treatment strategies for cognitive deficits remain limited compared to those addressing motor symptoms. Since no effective treatment currently exists to prevent or delay cognitive decline in PD, investigations into cognitive interventions are gaining increasing importance for understanding and managing this disabling aspect of the disease, which may emerge at all stages.

One promising intervention is RehaCom, a computer-based program that provides personalized cognitive training modules tailored to individual needs. Previous studies have demonstrated that RehaCom improves cognitive performance, enhances quality of life, and optimizes function in impaired domains. By prioritizing learning principles and offering individualized training for specific cognitive dimensions, RehaCom has also been shown to promote neural plasticity in patients with PD.

Motor learning literature emphasizes that not only training intensity but also conditions resembling real-life scenarios are critical for effective rehabilitation. Daily activities often require walking and maintaining balance while simultaneously performing additional tasks, such as speaking (cognitive dual-task) or carrying an object (motor dual-task). Dual-task training, which integrates motor training with either a cognitive or an additional motor task, is a comprehensive approach supported by strong evidence. Compared to single-task practice, dual-task training enhances motor learning, yields greater functional gains, and facilitates transfer of these improvements to activities of daily living.

Considering the deficiencies in cognition as a reason for the progressive and irreversible nature of the pathogenesis of PD, the present study hypothesizes that providing structured cognitive skills training will be more effective in improving both motor and cognitive functions. However, a review of the literature indicates that studies in this area remain limited. Therefore, the present study aims to implement and evaluate a rehabilitation program combining cognitive training with dual-task-focused balance and gait exercises in individuals with PD.

Conditions

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Cognition Parkinson's Disease Gait Disorders, Neurologic Balance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Training Combined with Dual-Task Training Group (DUAL-COG)

The intervention will start with core stability training, followed by dual-task balance and gait training. After completion of the dual-task training phase, participants will undergo structured cognitive training.

Group Type EXPERIMENTAL

Core Stability Training

Intervention Type OTHER

Core stability training will be designed to prepare participants for subsequent balance and gait exercises by promoting normal proprioceptive input through activation of deep core muscles. This training will be performed in the supine position at the beginning of each session for both groups.

Dual-Task Balance and Gait Training

Intervention Type OTHER

Dual-task balance and gait training will be provided with task-oriented motor-cognitive and motor-motor exercises with the augmented and virtual reality system C-Mill VR+ (Motek Medical, Amsterdam, The Netherlands). Sessions will be individualized based on each participant's current abilities and the difficulty level of the tasks to address specific patient needs. Each training session will have a duration of 30 minutes for both groups.

Cognitive Training

Intervention Type OTHER

Cognitive training will be provided with RehaCom software, a program that emphasizes learning principles, provides task-specific exercises, delivers positive feedback, and allows individualized progression based on patient-specific difficulty levels. In the present study, the cognitive training will target the "Attention," "Memory," and "Executive Functions" domains, which are known to be affected from the early stages of Parkinson's disease. Exercises will be initiated at a level appropriate to each participant's cognitive abilities and will gradually increase in difficulty. Each training session will have a duration of 30 minutes.

Dual-Task Training Group (DUAL)

The intervention will start with core stability training, followed by dual-task balance and gait training.

Group Type ACTIVE_COMPARATOR

Core Stability Training

Intervention Type OTHER

Core stability training will be designed to prepare participants for subsequent balance and gait exercises by promoting normal proprioceptive input through activation of deep core muscles. This training will be performed in the supine position at the beginning of each session for both groups.

Dual-Task Balance and Gait Training

Intervention Type OTHER

Dual-task balance and gait training will be provided with task-oriented motor-cognitive and motor-motor exercises with the augmented and virtual reality system C-Mill VR+ (Motek Medical, Amsterdam, The Netherlands). Sessions will be individualized based on each participant's current abilities and the difficulty level of the tasks to address specific patient needs. Each training session will have a duration of 30 minutes for both groups.

Interventions

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Core Stability Training

Core stability training will be designed to prepare participants for subsequent balance and gait exercises by promoting normal proprioceptive input through activation of deep core muscles. This training will be performed in the supine position at the beginning of each session for both groups.

Intervention Type OTHER

Dual-Task Balance and Gait Training

Dual-task balance and gait training will be provided with task-oriented motor-cognitive and motor-motor exercises with the augmented and virtual reality system C-Mill VR+ (Motek Medical, Amsterdam, The Netherlands). Sessions will be individualized based on each participant's current abilities and the difficulty level of the tasks to address specific patient needs. Each training session will have a duration of 30 minutes for both groups.

Intervention Type OTHER

Cognitive Training

Cognitive training will be provided with RehaCom software, a program that emphasizes learning principles, provides task-specific exercises, delivers positive feedback, and allows individualized progression based on patient-specific difficulty levels. In the present study, the cognitive training will target the "Attention," "Memory," and "Executive Functions" domains, which are known to be affected from the early stages of Parkinson's disease. Exercises will be initiated at a level appropriate to each participant's cognitive abilities and will gradually increase in difficulty. Each training session will have a duration of 30 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed with idiopathic Parkinson's disease by a neurologist.
* Evaluated between Stage 1-3 according to the Hoehn and Yahr Staging Scale.
* Aged 40 years or older.
* Agreed to participate in the study after being given sufficient information.

Exclusion Criteria

* Patients with a Montreal Cognitive Assessment score of 20 and below.
* Patients with cardiovascular, vestibular, musculoskeletal or additional neurological disease.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi

OTHER

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Arzu Güçlü Gündüz

Professor, PhD, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emre Adıgüzel, Prof., MD.

Role: STUDY_DIRECTOR

Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital

Arzu Güçlü Gündüz, Prof., PT.

Role: STUDY_DIRECTOR

Gazi University

Locations

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Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital

Ankara, Üniversiteler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, Sinforiani E. A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. 2019;44(4):555-567. doi: 10.3233/NRE-192714.

Reference Type BACKGROUND
PMID: 31256092 (View on PubMed)

Yogev G, Giladi N, Peretz C, Springer S, Simon ES, Hausdorff JM. Dual tasking, gait rhythmicity, and Parkinson's disease: which aspects of gait are attention demanding? Eur J Neurosci. 2005 Sep;22(5):1248-56. doi: 10.1111/j.1460-9568.2005.04298.x.

Reference Type BACKGROUND
PMID: 16176368 (View on PubMed)

Rochester L, Hetherington V, Jones D, Nieuwboer A, Willems AM, Kwakkel G, Van Wegen E. Attending to the task: interference effects of functional tasks on walking in Parkinson's disease and the roles of cognition, depression, fatigue, and balance. Arch Phys Med Rehabil. 2004 Oct;85(10):1578-85. doi: 10.1016/j.apmr.2004.01.025.

Reference Type BACKGROUND
PMID: 15468014 (View on PubMed)

Fritz NE, Cheek FM, Nichols-Larsen DS. Motor-Cognitive Dual-Task Training in Persons With Neurologic Disorders: A Systematic Review. J Neurol Phys Ther. 2015 Jul;39(3):142-53. doi: 10.1097/NPT.0000000000000090.

Reference Type BACKGROUND
PMID: 26079569 (View on PubMed)

Cerasa A, Gioia MC, Salsone M, Donzuso G, Chiriaco C, Realmuto S, Nicoletti A, Bellavia G, Banco A, D'amelio M, Zappia M, Quattrone A. Neurofunctional correlates of attention rehabilitation in Parkinson's disease: an explorative study. Neurol Sci. 2014 Aug;35(8):1173-80. doi: 10.1007/s10072-014-1666-z. Epub 2014 Feb 20.

Reference Type BACKGROUND
PMID: 24554416 (View on PubMed)

Leung IH, Walton CC, Hallock H, Lewis SJ, Valenzuela M, Lampit A. Cognitive training in Parkinson disease: A systematic review and meta-analysis. Neurology. 2015 Nov 24;85(21):1843-51. doi: 10.1212/WNL.0000000000002145. Epub 2015 Oct 30.

Reference Type BACKGROUND
PMID: 26519540 (View on PubMed)

Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.

Reference Type BACKGROUND
PMID: 22275317 (View on PubMed)

Jessen F, Amariglio RE, van Boxtel M, Breteler M, Ceccaldi M, Chetelat G, Dubois B, Dufouil C, Ellis KA, van der Flier WM, Glodzik L, van Harten AC, de Leon MJ, McHugh P, Mielke MM, Molinuevo JL, Mosconi L, Osorio RS, Perrotin A, Petersen RC, Rabin LA, Rami L, Reisberg B, Rentz DM, Sachdev PS, de la Sayette V, Saykin AJ, Scheltens P, Shulman MB, Slavin MJ, Sperling RA, Stewart R, Uspenskaya O, Vellas B, Visser PJ, Wagner M; Subjective Cognitive Decline Initiative (SCD-I) Working Group. A conceptual framework for research on subjective cognitive decline in preclinical Alzheimer's disease. Alzheimers Dement. 2014 Nov;10(6):844-52. doi: 10.1016/j.jalz.2014.01.001. Epub 2014 May 3.

Reference Type BACKGROUND
PMID: 24798886 (View on PubMed)

Aarsland D, Andersen K, Larsen JP, Lolk A, Nielsen H, Kragh-Sorensen P. Risk of dementia in Parkinson's disease: a community-based, prospective study. Neurology. 2001 Mar 27;56(6):730-6. doi: 10.1212/wnl.56.6.730.

Reference Type BACKGROUND
PMID: 11274306 (View on PubMed)

Zaman V, Shields DC, Shams R, Drasites KP, Matzelle D, Haque A, Banik NL. Cellular and molecular pathophysiology in the progression of Parkinson's disease. Metab Brain Dis. 2021 Jun;36(5):815-827. doi: 10.1007/s11011-021-00689-5. Epub 2021 Feb 18.

Reference Type BACKGROUND
PMID: 33599945 (View on PubMed)

Other Identifiers

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TABED 1/ 985/ 2025

Identifier Type: -

Identifier Source: org_study_id

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