Telerehabilitation Dual-Task Training for Parkinson's: A Multidimensional Evaluation

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 30 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Multidimensional Evaluation of the Effectiveness of Telerehabilitation-Based Dual-Task Training in Parkinson's Patients

Conditions

Parkinson Disease

Being tested

Cognitive-Motor Dual Task Activities, Motor-Motor Dual Task Activities, Cognitive-Motor & Motor-Motor Dual Task Activities

Medical subject headings

Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Cognitive-Motor Dual Task ActivitiesOther

  Patients included in this group will be given additional cognitive tasks (e.g. counting months, subtracting 5 from 100) in accordance with the physiotherapist's commands simultaneously with balance and large amplitude functional activities (such as stepping forward-sideways-backwards, sitting and standing).

• Motor-Motor Dual Task ActivitiesOther

  Patients included in this group will be given additional motor tasks (e.g. passing the ball from the right hand to the left hand while standing on a soft surface, clapping) in accordance with the physiotherapist's commands simultaneously with balance and large amplitude functional activities (such as stepping forward-sideways-backwards, sitting and standing).

• Cognitive-Motor & Motor-Motor Dual Task ActivitiesOther

  Simultaneously with balance and large amplitude functional activities (such as stepping forwards-sideways-backwards, sitting and standing), patients included in this group will be given additional cognitive (e.g. counting while standing with feet closed) and motor (e.g. passing the ball from the right hand to the left hand while standing on a soft surface) tasks in accordance with the physiotherapist's commands.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Feasibility Assessment

   The study's feasibility will be assessed through various measures. Firstly, we'll assess Participation Rate by calculating the ratio of attended sessions to the total. Participants will provide reasons for missed sessions, and their feedback will be recorded. After each session, participants will rate their fatigue on the Borg Perceived Exertion Scale, aiming to keep effort levels moderate (scores 12-17). To evaluate difficulty, participants will rate dual-task exercises on a Visual Analog Scale (0-10). Higher scores indicate greater difficulty, averaged over the study. Finally, at the end of the four-week program, participant satisfaction will be evaluated using a telerehabilitation-based exercise program questionnaire.

   Measured: Baseline and after the interventions (4th week)

2. Digit Span Test

   The Digit Span Test, consisting of forward and backward sequences, is administered separately. Each sequence comprises numbers with digits incrementing sequentially. Numbers are read aloud to the subject at a rate of one per second. Success in any trial prompts the initiation of the next trial. However, failure in both trials results in discontinuation of the test. The length of the last successfully repeated sequence determines the span range.

   Measured: Baseline and after the interventions (4th week)

3. Mental Flexibility

   In the Mini-Mental State Examination, as part of the Attention and Calculation subsection, individuals are asked to subtract 7 repeatedly from 100, continuing until reaching 65. Those with five years of education or less who cannot complete this task are then asked to perform an alternative task: counting the days of the week starting from Sunday and counting backwards. In both assessments, one point is awarded for each correct operation.

   Measured: Baseline and after the interventions (4th week)

4. Word Fluency Test

   This test is based on saying as many words that are not proper nouns or verbs beginning with the letters F, A, S as possible in one minute. One minute is given for each letter. The total score is equal to the total number of words uttered in all letters. It measures verbal-phonemic fluency. In the standardisation study conducted in our country, the letters K, A, S were used. In this study, the total number of words will be evaluated.

   Measured: Baseline and after the interventions (4th week)

5. Gait Assessment

   Kinovea® version 0.8.15 software will be utilized to obtain objective and quantitative data for spatiotemporal parameters of gait (stride length, double stride length, support surface, stride width, cadence, walking speed, step duration) and kinematic parameters of gait. In the study, a 3-meter walking distance of the subjects will be recorded with a camera placed in the sagittal plane. Coloured marks will be placed on the right and left heels, and these marks will be tracked and annotated on the video. The obtained videos will be observed, and the parameters of stride length (the distance between two consecutive heel strikes of one limb and the other limb) and double stride length (the distance between two consecutive heel strikes of the same limb) will be analyzed independently with Kinovea motion analysis software.

   Measured: Baseline and after the interventions (4th week)

6. Mini-BEST Test

   The Mini-BEST test, which will be used for dynamic balance assessment, is a 14-item balance scale and evaluates postural reactions, sensory orientation and dynamic walking sub-parameters. In the last part, it allows the assessment of dual-task performance within the scope of the Forced-Reach-Walk Test (with Cognitive Loading). Each item in the test is scored between (0-2); a score of 0 indicates that the person is unable to perform the task, while a score of 2 is normal. The total score will be between 0 and 28. The total score reflects the balance ability. Higher scores mean better balance ability. It is a valid and reliable measurement method that requires approximately 15 minutes to complete, is one-dimensional and valid for use in Parkinson's Disease.

   Measured: Baseline and after the interventions (4th week)

7. Four-step square test

   The four-step square test is a clinical assessment used to evaluate the ability to change direction while stepping, particularly focusing on dynamic balance and mobility. During the test, the patient starts in the upper left square (Square 1) and faces Square 2. The step sequence initially moves clockwise: Square 1, then Squares 2, 4, and 3. Subsequently, the sequence reverses, moving anti-clockwise: Square 3, followed by Squares 4, 2, and back to Square 1. The physiotherapist demonstrates the test, allowing the patient to practice and learn the sequence. If the patient cannot complete the sequence successfully, loses balance, or touches a support cane, the test is repeated. Two scores are obtained, and the better of the two scores is recorded. Timing begins when the patient's first foot touches the floor in Square 2 and ends when their second foot touches the floor in Square 1. The shorter the time, the better the result for this test.

   Measured: Baseline and after the interventions (4th week)

8. Postural Stability Assessment

   KFORCE Plates are a type of force platform utilized to objectively measure postural control parameters. These plates enable the assessment of both static and dynamic balance across a broad spectrum of movements. Consisting of two independent plates, they have the capability to determine weight distribution during the stance phase and calculate the center of gravity. KFORCE Plates evaluate various positions such as standing, single-leg stance, and squatting, providing a comprehensive report with multiple data points post-assessment. This assessment will significantly enhance the project by offering objective data on changes in postural control following exercise interventions and allowing for a more detailed interpretation compared to scale-based assessments.

   Measured: Baseline and after the interventions (4th week)

9. Parkinson's Activity Scale

   Parkinson's Activity Scale, a scale developed to evaluate functional activities in Parkinson's Disease, provides information about the transfer status of patients. Scored between 0 and 4 points, a high score indicates good performance. The scale has subdivisions including getting up from a chair, in-bed mobilisation and gait akinesia. In this study, it will be used to evaluate the functional activity status of the patients. High score indicates good functional performance.

   Measured: Baseline and after the interventions (4th week)

10. Dual Task Questionnaire

    The Dual Task Questionnaire consists of 10 questions designed to assess the frequency of difficulties associated with daily tasks involving dual tasking. It is used to measure how often individuals have problems with the content of the questionnaire. In response to the questions, individuals are asked to choose from five options ranging from very often to never or not applicable (5-point scale, using a 0-4 scale). The resulting score is divided by 10 for an average rating per question.

    Measured: Baseline and after the interventions (4th week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 May 2024
2. Study start1 Sep 2024
3. Primary completion1 Dec 2025 (estimated)
4. Study completion1 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
• More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.