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Effect of Hand Rehabilitation on Cognitive Function in Patients With PD

10. juli 2026 opdateret af: Hamid Reza Rostami, Isfahan University of Medical Sciences

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
  2. 40-65 years old: age of peak incidence of PD;
  3. Minimum 2 years and maximum 10 years from initial diagnosis: stabilization of the disease process and medications;
  4. disability level of at most 3 in the Modified Hoehn and Yahr Scale: physically independent;
  5. Mild cognitive impairment: score between 20 and 26 in Montreal cognitive assessment;
  6. Signing the written informed consent.

Exclusion Criteria:

  1. Patients with neurological diseases other than PD
  2. Patients with orthopedic and internal diseases that would make participation in the study difficult

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
10 one-and-a-half-hour sessions, 3 sessions per week
Aktiv komparator: 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
10 one-and-a-half-hour sessions, 3 sessions per week
10 one-and-a-half-hour sessions, 3 sessions per week

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Montreal Cognitive Assessment
Tidsramme: - The day before the intervention - The day after the intervention - One month after the last intervention session
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
- The day before the intervention - The day after the intervention - One month after the last intervention session
Cambridge Neuropsychological Test Automated Battery - Reaction Time
Tidsramme: - The day before the intervention - The day after the intervention - One month after the last intervention session
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.
- The day before the intervention - The day after the intervention - One month after the last intervention session
Cambridge Neuropsychological Test Automated Battery - Spatial Span Test
Tidsramme: - The day before the intervention - The day after the intervention - One month after ending intervention
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
- The day before the intervention - The day after the intervention - One month after ending intervention
Cambridge Neuropsychological Test Automated Battery - Match to Sample Visual Search Test
Tidsramme: - The day before the intervention - The day after the intervention - One month after the last intervention session
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.
- The day before the intervention - The day after the intervention - One month after the last intervention session
Cambridge Neuropsychological Test Automated Battery - Stop Signal Task
Tidsramme: - The day before the intervention - The day after the intervention - One month after the last intervention session
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
- The day before the intervention - The day after the intervention - One month after the last intervention session
KING'S PD Pain Scale
Tidsramme: - The day before staring intervention - The day after ending intervention - one month after ending intervention
this tool measures pain which is specifically designed for patients with PD.
- The day before staring intervention - The day after ending intervention - one month after ending intervention
Box & Block Test
Tidsramme: - The day before starting intervention - The day after ending intervention - One month after ending intervention
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.
- The day before starting intervention - The day after ending intervention - One month after ending intervention
The Purdue Pegboard Test
Tidsramme: - 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.
- The day before starting intervention - The day after ending intervention - One month after ending intervention
Hand Dynamometer Hydraulic Jamar
Tidsramme: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This tool measures hand grip strength.
- The day before starting intervention - The day after ending intervention - One month after ending intervention
Pinch gauge
Tidsramme: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This tool measures fine fingertip grip strength
- The day before starting intervention - The day after ending intervention - One month after ending intervention
Semmes-Weinstein monofilaments
Tidsramme: - The day before staring intervention - The day after ending intervention - one month after ending intervention
This test assesses the tactile pressure perception threshold
- The day before staring intervention - The day after ending intervention - one month after ending intervention
The Michigan Hand Outcome Questionnaire
Tidsramme: - The day before staring intervention - The day after ending intervention - one month after ending intervention
It measures the individual's own perspective on overall hand function
- The day before staring intervention - The day after ending intervention - one month after ending intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hamid Reza Rostami, PhD, Isfahan University of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

23. juli 2026

Primær færdiggørelse (Anslået)

23. juli 2027

Studieafslutning (Anslået)

23. november 2027

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

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Kliniske forsøg med PARKINSON SYGGE (lidelse)

Kliniske forsøg med Hand Sensorimotor Rehabilitation

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