- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07641556
The Effects of Tele-Rehabilitation-Based Dual-Task Upper Extremity Training in Patients With Parkinson's Disease
Investigating the Effects of Tele-Rehabilitation-Based Dual-Task Upper Extremity Training in Patients With Parkinson's Disease
The aim of this study is to compare the effects of tele-rehabilitation-based synchronous and asynchronous dual-task upper extremity training with clinical based dual-task upper extremity training and conventional single-task upper extremity training in patients with Parkinson's disease. The main questions it aims to answer are:
- Whether there are differences in motor symptoms, hand dexterity, upper extremity functions, grip strength, executive functions, daily living activities, and treatment satisfaction between tele-rehabilitation-based synchronous and asynchronous dual-task upper extremity training, clinical-based dual-task upper extremity training, and conventional single-task upper extremity training in patients with Parkinson's disease.
- Whether there is a difference in telemedicine satisfaction between tele-rehabilitation-based synchronous and asynchronous dual-task upper extremity training in patients with Parkinson's disease.
Researchers will compare conventional single-task upper extremity training, clinical-based dual-task upper extremity training, tele-rehabilitation-based synchronous upper extremity training and tele-rehabilitation-based asynchronous upper extremity training.
Participants will:
- Receive upper extremity exercise training at the study clinic or home, twice a week for approximately 60 minutes each time, for 6 weeks.
- Participate in assessments at the study clinic before and after exercise training.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
- Jiný: Conventional Single Task Upper Extremity Exercise Training
- Jiný: Clinic-Based Dual Task Upper Extremity Exercise Training
- Jiný: Tele-Rehabilitation Based Synchronous Dual Task Upper Extremity Exercise Training
- Jiný: Tele-Rehabilitation Based Asynchronous Dual Task Upper Extremity Exercise Training
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Having been diagnosed with Parkinson's disease by a neurologist according to the UK Brain Bank criteria
- Being in stage 3 or higher according to the Hoehn-Yahr Scale
- Having a caregiver capable of providing the necessary assistance during tele-rehabilitation sessions and using the required equipment and programs.
- Having the device and software to conduct remote video calls for tele-rehabilitation
Exclusion Criteria:
- Presence of a neurological disease other than Parkinson's disease
- Cognitive impairment (Standardized Mini Mental Test score less than 24)
- Having undergone deep brain stimulation surgery
- Having a visual, auditory, or perceptual problem
- Having any orthopedic, rheumatological, or other condition that may affect hand functions
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Single Task Training
Conventional, clinic-based, single task upper extremity training
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Conventional single task upper extremity exercise training at clinical setting.
The first 5 minutes of the training session will consist of a warm-up period of stretching and breathing exercises, followed by a cool-down period of the same exercises.Nine different upper extremity activities (using a fork and spoon, tying shoelaces, reaching, throwing a ball, filling water, folding a sheet, drawing shapes, buttoning, and fastening nuts) will be performed for 3 minutes each, in a random order.
A 2-minute rest period will be given between each activity.
|
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Experimentální: Clinic-Based Dual Task Training
Clinic-based, dual task upper extremity training
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Dual task upper extremity exercise training at clinical setting.
The first 5 minutes of the training session will consist of a warm-up period of stretching and breathing exercises, followed by a cool-down period of the same exercises.Nine different upper extremity activities (using a fork and spoon, tying shoelaces, reaching, throwing a ball, filling water, folding a sheet, drawing shapes, buttoning, and fastening nuts) will be performed simultaneously with three randomly selected cognitive tasks (arithmetic task, verbal fluency, digit span) for 3 minutes each, in a random order.
A 2-minute rest period will be given between each activity.
|
|
Experimentální: Tele-Rehabilitation Based Synchronous Dual Task Training
Tele-rehabilitation based synchronous dual task upper extremity training
|
Dual task upper extremity exercise training at patient's home, synchronous with a researcher via tele-rehabilitation method.
The first 5 minutes of the training session will consist of a warm-up period of stretching and breathing exercises, followed by a cool-down period of the same exercises.Nine different upper extremity activities (using a fork and spoon, tying shoelaces, reaching, throwing a ball, filling water, folding a sheet, drawing shapes, buttoning, and fastening nuts) will be performed simultaneously with three randomly selected cognitive tasks (arithmetic task, verbal fluency, digit span) for 3 minutes each, in a random order.
A 2-minute rest period will be given between each activity.
|
|
Experimentální: Tele-Rehabilitation Based Asynchronous Dual Task Training
Tele-rehabilitation based asynchronous dual task upper extremity training
|
Dual task upper extremity exercise training at patient's home, asynchronous under a researcher supervision.
It will be carried out according to the pre-determined schedule and will be video recorded.
The first 5 minutes of the training session will consist of a warm-up period of stretching and breathing exercises, followed by a cool-down period of the same exercises.Nine different upper extremity activities (using a fork and spoon, tying shoelaces, reaching, throwing a ball, filling water, folding a sheet, drawing shapes, buttoning, and fastening nuts) will be performed simultaneously with three randomly selected cognitive tasks (arithmetic task, verbal fluency, digit span) for 3 minutes each, in a random order.
A 2-minute rest period will be given between each activity.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) - PART 3
Časové okno: From enrollment to the end of training at 6 weeks
|
UPDRS is a reliable and valid scale that assesses cognitive skills, mood, daily living activities, motor skills, motor fluctuations, dyskinesias and autonomic dysfunction and is widely used in clinical studies and research in Parkinson's disease.
The motor symptoms section, which is the third section of this scale, will be used.
|
From enrollment to the end of training at 6 weeks
|
|
Hoehn & Yahr Scale
Časové okno: From enrollment to the end of treatment at 6 weeks
|
It is a staging system that provides information quickly in determining the severity and symptoms of Parkinson's disease.
|
From enrollment to the end of treatment at 6 weeks
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) - PART 2
Časové okno: From enrollment to the end of treatment at 6 weeks
|
It consists of thirteen items.
The assessment is based on anamnesis information regarding how the patient functions in various activities.
The presence of sensory complaints that may be related to tremor and parkinsonism is also included in this section as they can affect daily living activities.
Each item is evaluated using a scoring system between '0' and '4'.
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From enrollment to the end of treatment at 6 weeks
|
|
Trail Making Test
Časové okno: From enrollment to the end of treatment at 6 weeks
|
It is used to assess executive functions and attention.
The test consists of two 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 a sequence where each number corresponds to a letter, and the completion time is recorded.
|
From enrollment to the end of treatment at 6 weeks
|
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Nine-Hole Peg Test
Časové okno: From enrollment to the end of treatment at 6 weeks
|
During the test, individuals use only one hand to pick up nine wooden pegs one by one and insert them into the holes as quickly as possible.
After inserting all the pegs, they quickly place them back into the container one by one.
The timer starts when the individual touches the first peg and ends when the last peg is placed back into the container.
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From enrollment to the end of treatment at 6 weeks
|
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Coin Rotation Test
Časové okno: From enrollment to the end of treatment at 6 weeks
|
This test assesses the coordination of independent finger movements.
In this test, the person is asked to rotate a coin 180 degrees as many times as possible between their thumb, index finger, and middle finger within 10 seconds without dropping it.
The person's performance is video recorded and later analyzed.
An increase in the number of times the patient rotates the coin within 10 seconds indicates better fine motor skills.
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From enrollment to the end of treatment at 6 weeks
|
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Manual Ability Measure-36
Časové okno: From enrollment to the end of treatment at 6 weeks
|
This is a 36-question survey that assesses fine motor skills based on individual self-reports.
The survey includes questions related to daily life, such as drinking water, tying shoelaces, brushing teeth, and turning book pages.
Each question is scored from 0 (almost impossible) to 4 (easy).
The resulting score is converted to a 100-point system.
Higher scores indicate good fine motor skills.
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From enrollment to the end of treatment at 6 weeks
|
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Grip Strength
Časové okno: From enrollment to the end of treatment at 6 weeks
|
Grip strength will be assessed using a Jamar hand dynamometer (JAMAR®, Performance Health Holdings, Inc., USA).
During the tests, the individual will be positioned in a chair with the arm at the side of the body, the elbow flexed at 90°, and the wrist in a neutral position.
Individuals will be asked to make a fist to assess their grip strength.
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From enrollment to the end of treatment at 6 weeks
|
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Dual-Task Impact on Daily-Living Activities Questionnaire
Časové okno: From enrollment to the end of treatment at 6 weeks
|
This test is used to assess the difficulties experienced in daily tasks involving dual task execution.
It consists of 19 questions, with a scale of 0 (not difficult at all) to 4 (extremely difficult).
A higher overall score indicates a higher perceived level of difficulty when performing dual tasks during daily life activities.
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From enrollment to the end of treatment at 6 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Treatment Satisfaction
Časové okno: At end of treatment at 6 weeks
|
Patient satisfaction with treatment will be assessed post-treatment using a 100 mm long visual-analog scale.
|
At end of treatment at 6 weeks
|
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Telemedicine Satisfaction Questionnaire
Časové okno: At end of treatment at 6 weeks
|
This survey consists of 14 items.
It assesses patients' satisfaction levels with the software or system they use for treatment or other remote rehabilitation services.
The total score ranges from 14 to 70, with a maximum of 5 points per question.
A higher score indicates higher satisfaction.
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At end of treatment at 6 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-151
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