- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07702929
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
Effect of Sensory-motor Rehabilitation of the Hand on Cognitive Functions in Patients With Parkinson's Disease
Evidence suggests the association between fine motor skills of the hand and cognitive function, as well as the positive effects of hand rehabilitation on hand function and the effectiveness of cognitive rehabilitation on cognitive functions in patients with Parkinson's disease (PD). In response to the question of whether there is a cause-and-effect relationship between fine manual skills and cognitive function, we designed the present randomized controlled trial to investigate the effectiveness of sensory-motor rehabilitation of the hand on cognitive functions compared to the effectiveness of cognitive rehabilitation on sensory-motor skills of the hand in patients with PD.
In this double-blinded, randomized controlled trial, a convenience sample including 32 people with PD will participate based on simple non-random sampling. The participants will be allocated randomly through stratified randomization to parallel groups of intervention (sensorimotor hand rehabilitation) and control (cognitive rehabilitation) with a 1:1 allocation ratio. The associate researcher responsible for assessing outcome measures and the statistician responsible for analyzing the data are blinded to the intervention protocol. The intervention protocol for the intervention group includes hand sensory-motor rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week, in addition to cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. The intervention protocol for the control group includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. All participants undergo three assessment sessions: the day before the intervention, the day after the intervention, and one month after the last intervention session. Data will be analyzed using SPSS version 22.0. The significance level will be set at 0.05.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hamid Reza Rostami, PhD
- Telefonní číslo: 00989134328034
- E-mail: hrr.rostami@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
- 40-65 years old: age of peak incidence of PD;
- Minimum 2 years and maximum 10 years from initial diagnosis: stabilization of the disease process and medications;
- disability level of at most 3 in the Modified Hoehn and Yahr Scale: physically independent;
- Mild cognitive impairment: score between 20 and 26 in Montreal cognitive assessment;
- Signing the written informed consent.
Exclusion Criteria:
- Patients with neurological diseases other than PD
- Patients with orthopedic and internal diseases that would make participation in the study difficult
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Hand Sensorimotor Rehabilitation
The intervention protocol includes hand sensory-motor rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week, in addition to cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week.
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10 one-and-a-half-hour sessions, 3 sessions per week
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Aktivní komparátor: Cognitive Rehabilitation
The intervention protocol includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week.
The cognitive rehabilitation program will be conducted the same as the cognitive rehabilitation for the intervention group, which was explained in the previous section
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10 one-and-a-half-hour sessions, 3 sessions per week
10 one-and-a-half-hour sessions, 3 sessions per week
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Montreal Cognitive Assessment
Časové okno: - The day before the intervention - The day after the intervention - One month after the last intervention session
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To assess the general cognitive status of the participants.
In the scoring of this test, a score of 26 and above indicates normal cognitive function, a score of 25 and below indicates mild cognitive impairment, and a score below 20 means severe cognitive impairment
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- The day before the intervention - The day after the intervention - One month after the last intervention session
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Cambridge Neuropsychological Test Automated Battery - Reaction Time
Časové okno: - The day before the intervention - The day after the intervention - One month after the last intervention session
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To measure the speed of the participants' response to a visual target in which a predictable (simple reaction time) or unpredictable (choice reaction time) stimulus is presented.
The approximate test time is 5 minutes.
The response time latency is measured in milliseconds.
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- The day before the intervention - The day after the intervention - One month after the last intervention session
|
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Cambridge Neuropsychological Test Automated Battery - Spatial Span Test
Časové okno: - The day before the intervention - The day after the intervention - One month after ending intervention
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This test examines working and short-term memory.
The participants are asked to tap on the squares on the monitor screen as they light up, in the order they appear.
The approximate time to complete the test is 5 minutes
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- The day before the intervention - The day after the intervention - One month after ending intervention
|
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Cambridge Neuropsychological Test Automated Battery - Match to Sample Visual Search Test
Časové okno: - The day before the intervention - The day after the intervention - One month after the last intervention session
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This test measures attention and visual search.
In this test, a complex visual pattern is displayed in the middle of the monitor screen.
After a short delay, a variable number of similar patterns are displayed in a circle around the edge of the monitor screen.
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- The day before the intervention - The day after the intervention - One month after the last intervention session
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Cambridge Neuropsychological Test Automated Battery - Stop Signal Task
Časové okno: - The day before the intervention - The day after the intervention - One month after the last intervention session
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This test measures response inhibition.
The test consists of two parts: in the first part, the participant is told to press the left button when they see an arrow pointing to the left direction and the right button when they see an arrow pointing right; In the second part, the participant is told to continue selecting buttons while they see the arrows, but if they hear an audible signal (beep), they must hold their response and not select the button
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- The day before the intervention - The day after the intervention - One month after the last intervention session
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KING'S PD Pain Scale
Časové okno: - The day before staring intervention - The day after ending intervention - one month after ending intervention
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this tool measures pain which is specifically designed for patients with PD.
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- The day before staring intervention - The day after ending intervention - one month after ending intervention
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Box & Block Test
Časové okno: - The day before starting intervention - The day after ending intervention - One month after ending intervention
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This test assesses hand fine motor skills by moving one-inch wooden cubes from one side of a 5.8 x 4.25 x 7.53 cm box to the other side.
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- The day before starting intervention - The day after ending intervention - One month after ending intervention
|
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The Purdue Pegboard Test
Časové okno: - The day before starting intervention - The day after ending intervention - One month after ending intervention
|
This test assesses fine motor skills and hand-eye coordination.
The assembly subtest will considered in the present study.
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- The day before starting intervention - The day after ending intervention - One month after ending intervention
|
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Hand Dynamometer Hydraulic Jamar
Časové okno: - The day before starting intervention - The day after ending intervention - One month after ending intervention
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This tool measures hand grip strength.
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- The day before starting intervention - The day after ending intervention - One month after ending intervention
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Pinch gauge
Časové okno: - The day before starting intervention - The day after ending intervention - One month after ending intervention
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This tool measures fine fingertip grip strength
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- The day before starting intervention - The day after ending intervention - One month after ending intervention
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Semmes-Weinstein monofilaments
Časové okno: - The day before staring intervention - The day after ending intervention - one month after ending intervention
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This test assesses the tactile pressure perception threshold
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- The day before staring intervention - The day after ending intervention - one month after ending intervention
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The Michigan Hand Outcome Questionnaire
Časové okno: - The day before staring intervention - The day after ending intervention - one month after ending intervention
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It measures the individual's own perspective on overall hand function
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- The day before staring intervention - The day after ending intervention - one month after ending intervention
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Hamid Reza Rostami, PhD, Isfahan University of Medical Sciences
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2404210
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