NCT06794177

Brief Summary

This study was planned to investigate and compare the effects of variable and fixed priority dual task training on balance, walking skills, mobility and cognition in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

January 21, 2025

Last Update Submit

October 2, 2025

Conditions

Outcome Measures

Primary Outcomes (17)

  • Hoehn and Yahr Scale

    A staging system that quickly provides information in determining the degree and symptom severity of the disease

    Baseline, 6 weeks

  • Unified Parkinson's Disease Rating Scale

    Evaluates cognitive skills, mood, activities of daily living, motor skills, motor fluctuations, dyskinesias, and autonomic dysfunction in four parts

    Baseline, 6 weeks

  • Berg Balance Scale

    It includes 14 functional activities to assess static and proactive balance. The total score ranges from 0 to 56, with higher scores indicating better balance.

    Baseline, 6 weeks

  • Functional Reach Test

    The test is designed to assess dynamic balance by measuring the maximum distance that a person can reach forward beyond arm's length without taking a step.

    Baseline, 6 weeks

  • Single Leg Stance Test

    It is a test method used to evaluate static balance. One foot is lifted without touching the supporting leg and the person is expected to maintain their balance for 30 seconds.

    Baseline, 6 weeks

  • Four Square Step Test

    It is a test method used to evaluate dynamic balance. Two canes are placed on a flat surface to create 4 squares. All squares are numbered. The subject starts in one square and steps in one direction into each of the four squares and then reverses direction back to the start. The time (in seconds) taken to complete the sequence is measured.

    Baseline, 6 weeks

  • 10 Meter Walk Test

    Used to assess walking speed. Participants are asked to walk a distance of 10 meters and the time taken is recorded.

    Baseline, 6 weeks

  • Figure-of-Eight Walk Test

    The participant stands still at the midpoint of two cones placed 1.52 m apart and begins walking around the cones in a figure eight at his/her usual pace. The total time and number of steps taken to complete the test are recorded.

    Baseline, 6 weeks

  • 3-Meter Backward Walk Test

    The 3-meter distance is measured and marked. Participants are asked to walk backwards as quickly as possible with the "walk" command and to stop when they reach 3 meters. The elapsed time is recorded in seconds.

    Baseline, 6 weeks

  • Timed Up and Go Test

    It is used to assess functional mobility level. The participant is asked to stand up from the chair, walk 3 m, turn around, walk back to the chair and sit down. The test starts with the "walk" command and the completion time is recorded in seconds.

    Baseline, 6 weeks

  • Unified Parkinson's Disease Rating Scale, Part 2

    UPDRS Part 2 generally is considered a psychometrically reliable tool for measuring activities of daily living outcomes in people with Parkinson's disease.

    Baseline, 6 weeks

  • Dual Task Questionnaire

    It is used to obtain information about the difficulties experienced in daily tasks related to dual task. It consists of 10 questions, each question is scored between 0 and 4.

    Baseline, 6 weeks

  • Trail Making Test

    It is used to evaluate individuals' visual scanning speed, executive functions, visual-motor perception, motor function, planning, organization, abstract thinking and response limitation. The test consists of 2 parts: A and B. In part A, the individual is asked to combine numbers from 1 to 25 and the completion time is recorded. In part B, the individual completes the sequence by corresponding to a number and a letter, and the completion time is recorded.

    Baseline, 6 weeks

  • Stroop Test

    It is a test that evaluates executive functions and the suppression of inappropriate automatic responses and provides information about frontal functions.

    Baseline, 6 weeks

  • Symbol Digit Modalities Test

    It is a test that measures working memory and information processing speed. In the upper right corner of the A4 paper used in the test, there is a grid of shapes, each representing a number. In the other parts of the paper, there are randomly arranged shapes in blocks. During the test, patients are asked to match these shapes with the numbers in the grid.

    Baseline, 6 weeks

  • Word List Generation

    It is a test used to evaluate complex attention functions and vocabulary. It consists of animal and KAS sections. First, the patient is asked to name every animal that comes to mind in one minute, as quickly as possible. In the KAS section, the patient is asked to name every word that comes to mind, except for proper nouns and city names, with the letters K-A-S in order. The time for each letter is again one minute.

    Baseline, 6 weeks

  • Tampa Scale for Kinesiophobia

    It is a 17-question scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. Each item is scored between 1-4.

    Baseline, 6 weeks

Study Arms (3)

Contol Group

ACTIVE COMPARATOR

Single task training

Other: Single task training

Variable priority dual task training group

EXPERIMENTAL

Variable priority dual task training

Other: Variable priority dual task training

Fixed priority dual task training group

EXPERIMENTAL

Fixed priority dual task training

Other: Fixed priority dual task training

Interventions

Variable priority dual task training with balance and walking exercises performed simultaneously with cognitive tasks, twice a week for six weeks

Variable priority dual task training group

Fixed priority dual task training with balance and walking exercises performed simultaneously with cognitive tasks, twice a week for six weeks

Fixed priority dual task training group

Single task training with balance and walking exercises, twice a week for six weeks

Contol Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having agreed to participate in the research after being given detailed information about the research.
  • Having been diagnosed with Parkinson's disease by a specialist neurologist according to the UK Brain Bank criteria
  • Being in stage 1-3 according to Hoehn \& Yahr
  • Being 40 years of age or older

You may not qualify if:

  • Having a neurological condition other than Parkinson's disease
  • Cognitive impairment
  • Have undergone deep brain stimulation surgery
  • Having a visual, auditory or perceptual problem
  • Having any orthopedic, rheumatological or other disease that may affect walking and balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sağlık Bilimleri Üniversitesi, Gülhane Fizyoterapi ve Rehabilitasyon Fakültesi

Ankara, 06018, Turkey (Türkiye)

Location

Gazi Üniversitesi Tıp Fakültesi Nöroloji Anabilim Dalı

Ankara, 06560, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

February 1, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations