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.

Study Overview

• Status: Not yet recruiting
• Conditions: PARKINSON DISEASE (Disorder)
• Intervention / Treatment: Other: Hand Sensorimotor Rehabilitation; Other: Cognitive Remediation

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamid Reza Rostami, PhD; Phone Number: 00989134328034; Email: hrr.rostami@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Hand Sensorimotor Rehabilitation; 10 one-and-a-half-hour sessions, 3 sessions per week
Active Comparator: 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	Other: Hand Sensorimotor Rehabilitation; 10 one-and-a-half-hour sessions, 3 sessions per week; Other: Cognitive Remediation; 10 one-and-a-half-hour sessions, 3 sessions per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Hamid Reza Rostami, PhD, Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 23, 2026
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): November 23, 2027

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Parkinson's Disease; Occupational Therapy; Cognition; Hand Function
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Remediation
• Other Study ID Numbers: 2404210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No