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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More Gazi University trials in Turkey

Other trials for the same condition