Effect of Hand Rehabilitation on Cognitive Function in Patients With PD

NCT07702929 | Not Yet Recruiting DMC

• 1 other identifier: 2404210
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 48 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Cognition; Hand Function; Parkinson's Disease; Occupational Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (12)

• Montreal Cognitive Assessment

  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

  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

  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

  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

  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

  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

  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

  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

  This tool measures hand grip strength.

  - The day before starting intervention - The day after ending intervention - One month after ending intervention

• Pinch gauge

  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

  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

  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

Study Arms (2)

Hand Sensorimotor Rehabilitation

EXPERIMENTAL

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.

Other: Hand Sensorimotor Rehabilitation

Cognitive Rehabilitation

ACTIVE COMPARATOR

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

Other: Hand Sensorimotor Rehabilitation; Other: Cognitive Remediation

Interventions

Hand Sensorimotor Rehabilitation OTHER

10 one-and-a-half-hour sessions, 3 sessions per week

Cognitive Rehabilitation; Hand Sensorimotor Rehabilitation

Cognitive Remediation OTHER

10 one-and-a-half-hour sessions, 3 sessions per week

Cognitive Rehabilitation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hamid Reza Rostami, PhD

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Reza Rostami, PhD

CONTACT

00989134328034; hrr.rostami@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician responsible for data analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hamid Reza Rostami

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): August 23, 2026
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): November 23, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share