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

NCT07213232 | Enrolling By Invitation DMC

• 1 other identifier: TABED 1/ 985/ 2025
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognition; Parkinson's Disease; Gait Disorders, Neurologic; Balance Disorders

Keywords

dual-task training; cognitive training; balance; gait; Parkinson's disease

Outcome Measures

Primary Outcomes (8)

• Change from Baseline in Static Standing Balance Parameters at 12 Training Sessions

  The static standing balance of participants will be assessed using the Huber 360° Evolution System (LPG Systems, Valence, France). The following measurements will be performed with this device: Postural Stability Test: Postural stability will be evaluated in parallel feet (eyes open/closed) and single-leg positions. Each test will be repeated three times, with a 10-second rest interval between repetitions. The displacement area (mm²), and path length (mm) of the center of pressure will be recorded. Additionally, during the test, the displacement of the center of pressure per unit time will be recorded as velocity (mm/s).

  From enrollment to the end of the 6-Week training program

• Change from Baseline in Dynamic Standing Balance Parameters at 12 Training Sessions

  The dynamic standing balance of participants will be assessed using the Huber 360° Evolution System (LPG Systems, Valence, France). The following measurements will be performed with this device: Limits of Stability Test: During the test, participants will be instructed to shift their weight toward eight different directions. Each test will be repeated three times, with a 10-second rest interval between repetitions. Outcome measures will include the displacement of the center of pressure in each direction (mm) and the sway area (mm²) resulting from the displacement of the center of pressure across all directions.

  From enrollment to the end of the 6-Week training program

• Change from Baseline in Spatial Gait Analysis Parameters at 12 Training Sessions

  The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used for the evaluation. The analysis will include the recording of step length (mm), step width (mm) and stride length (mm).

  From enrollment to the end of the 6-Week training program

• Change from Baseline in Temporal Gait Analysis Parameters at 12 Training Sessions

  The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used for the evaluation. The analysis will include the recording of stance phase duration (ms), swing phase duration (ms), and double support phase duration (ms).

  From enrollment to the end of the 6-Week training program

• Change from Baseline in Walking Distance Parameter at 12 Training Sessions

  The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used for the evaluation. The analysis will include the recording of walking distance (m) as a functional performance outcome.

  From enrollment to the end of the 6-Week training program

• Change from Baseline in Gait Speed at 12 Training Sessions

  The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used in the evaluation. The analysis will include recording the displacement of the individual per unit time on the running belt as gait speed (m/s).

  From enrollment to the end of the 6-Week training program

• Change from Baseline in Montreal Cognitive Assessment (MoCA) Score at 12 Training Sessions

  Montreal Cognitive Assessment (MoCA), which provides a general cognitive screening in different cognitive functions such as attention, concentration, executive functions, memory, language, visual structuring skills, abstract thought, calculation and orientation, will be used in the general evaluation of cognition. MoCA is an effective scale especially in the evaluation of mild cognitive impairments in Parkinson's disease (PD). The cut-off score range of MoCA has been shown to be 18-26 points in individuals with PD who has mild cognitive impairment. The administration of MoCA takes approximately 10 minutes. The highest total score that can be obtained from the test is 30. Accordingly, a score of 21 points and above is considered normal.

  From enrollment to the end of the 6-Week training program

• Change in Domain-Specific Cognitive Assessment Parameters from Baseline after 12 Training Sessions

  In the comprehensive evaluation of cognition, specific evaluation will be made for the sub-domains of cognition which are "Attention", "Memory" and "Executive Functions" will be made using the screening modules of the RehaCom software. Before each evaluation, a practice mode will be applied in which the patient is informed about the things to be careful about during the evaluation, the expected task and the purpose of the evaluation. In all screening results, the z-values, mean of reaction time (ms), median of reaction time (ms), standard deviation of reaction time (ms) and correct, incorrect, error and skip numbers in the tests will be recorded as standardized data compared with the data of at least 200 age and gender matched healthy individuals in RehaCom's database.

  From enrollment to the end of the 6-Week training program

Secondary Outcomes (3)

• Change from Baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3: Motor Examination Scores at 12 Training Sessions

  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

  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

  From enrollment to the end of the 6-Week training program

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Core Stability Training; Other: Dual-Task Balance and Gait Training; Other: Cognitive Training

Dual-Task Training Group (DUAL)

ACTIVE COMPARATOR

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

Other: Core Stability Training; Other: Dual-Task Balance and Gait Training

Interventions

Core Stability Training 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.

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

Dual-Task Balance and Gait Training 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 Combined with Dual-Task Training Group (DUAL-COG); Dual-Task Training Group (DUAL)

Cognitive Training 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.

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi: collaborator
• Gazi University: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital

Ankara, Üniversiteler, Turkey (Türkiye)

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 24798886 BACKGROUND

• 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.

  PMID: 11274306 BACKGROUND

• 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.

  PMID: 33599945 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Emre Adıgüzel, Prof., MD.

  Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital

  STUDY DIRECTOR

• Arzu Güçlü Gündüz, Prof., PT.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, PT

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 8, 2025
• Study Start: March 11, 2025
• Primary Completion: June 3, 2026
• Study Completion: June 3, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)