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

Официальное название

Investigation of the Effects of Dual-Task Balance and Gait Training Combined With Cognitive Training in Parkinson's Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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

Первичные конечные точки

• Change from Baseline in Static Standing Balance Parameters at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Dynamic Standing Balance Parameters at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Spatial Gait Analysis Parameters at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Temporal Gait Analysis Parameters at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Walking Distance Parameter at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Gait Speed at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Montreal Cognitive Assessment (MoCA) Score at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change in Domain-Specific Cognitive Assessment Parameters from Baseline after 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]

Вторичные конечные точки (3)

• Change from Baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3: Motor Examination Scores at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Activities-Specific Balance Confidence (ABC) Scale Scores at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]
• Change from Baseline in Percentile of Evaluation of Dual-Task Effect at 12 Training Sessions [Срок оценки: From enrollment to the end of the 6-Week training program]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital — Ankara

Публикации

• 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. PMID 31256092
• 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. PMID 16176368
• 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. PMID 15468014
• 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. PMID 26079569
• 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. PMID 24554416
• 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. PMID 26519540
• 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. PMID 22275317
• 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, Vel PMID 24798886

Идентификаторы

NCT: NCT07213232 · TABED 1/ 985/ 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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