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Effect of Hand Rehabilitation on Cognitive Function in Patients With PD

10 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Hand Sensorimotor Rehabilitation
10 one-and-a-half-hour sessions, 3 sessions per week
Comparatore attivo: 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
Altro: Hand Sensorimotor Rehabilitation
10 one-and-a-half-hour sessions, 3 sessions per week
Altro: Cognitive Remediation
10 one-and-a-half-hour sessions, 3 sessions per week

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Montreal Cognitive Assessment
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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
Lasso di tempo: - 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Isfahan University of Medical Sciences

Investigatori

  • Investigatore principale: Hamid Reza Rostami, PhD, Isfahan University of Medical Sciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

23 luglio 2026

Completamento primario (Stimato)

23 luglio 2027

Completamento dello studio (Stimato)

23 novembre 2027

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2404210

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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