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Effects of sensory-motor reeducation of the hand on cognitive functions in Parkinson's disease patients with mild cognitive disorders

Protocol summary

Study aim
Determining the effectiveness of hand sensorimotor retraining on cognitive functions compared to the effectiveness of cognitive functions retraining on hand sensorimotor functions in patients with Parkinson's disease
Design
Simple non-random sampling from the patients referred to the occupational therapy department of Ayatollah Kashani Hospital and the Parkinson's Association in Isfahan. Sample size: 30 people with Parkinson's disease(15 people in each group)
Settings and conduct
After approval by Isfahan University of Medical Sciences and acquisition of the IRCT code, 30 patients with Parkinson's disease will be randomly assigned to two groups of 15 each and undergo two types of treatment (intervention: hand sensorimotor retraining; control: cognitive rehabilitation). The person responsible for evaluating study variables will be blinded to groups and interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with Parkinson's disease 2. At least 2 years have passed since the initial diagnosis 3. Disability level of 2.5 and less on the Hoehn & Yahr scale 4. Age 50 to 65 years 5. Mild cognitive disorder (score between 20-26 on Montreal Cognitive Assessment Scale) Exclusion criteria: 1. Coexistence of diseases other than Parkinson's Disease
Intervention groups
Intervention group: Sensorimotor hand retraining for 10, one and a half hour sessions, 3 days per week Control group: Cognitive rehabilitation for 10, one and a half hour sessions, 3 days per week
Main outcome variables
1. Score of Montreal Cognitive Assessment (0-30) 2. score of Cambridge Computerized Cognitive Test 3. Score of Box&Block and Purdue PegBoard tests 4. Muscle strength in Dynamometer and Pinch Gauge testing 5. Tactile Pressure Perception Threshold 6. Score of Michigan Hand Outcome Questionnaire (0-76) 7. Score of KING’S Parkinson's Disease PAIN SCALE (0-12)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250406065222N1
Registration date: 2026-06-22, 1405/04/01
Registration timing: registered_while_recruiting

Last update: 2026-06-22, 1405/04/01
Update count: 0
Registration date
2026-06-22, 1405/04/01
Registrant information
Name
Hamid Reza Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 432 8034
Email address
hrr.rostami@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of sensory-motor reeducation of the hand on cognitive functions in Parkinson's disease patients with mild cognitive disorders
Public title
Effects of sensory-motor reeducation of the hand on cognitive functions in patients with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with Parkinson's disease diagnosed by a neurologist At least 2 years have passed since the initial diagnosis of Parkinson's disease Disability level of maximum 2.5 on the Hoehn & Yahr scale Age 50 to 65 years (age of highest prevalence of Parkinson's disease) Mild cognitive impairment (score between 20 and 26 on the Montreal Cognitive Assessment Scale)
Exclusion criteria:
Presence of diseases other than Parkinson's
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of 30 patients with Parkinson's disease through stratified randomization to two intervention groups (sensorimotor hand rehabilitation) and control (cognitive rehabilitation): - Type of randomization: stratified randomization; - Randomization layers: First layer: score 1 to 1.5 on the Hoehn and Yahr scale, second layer: score 2 to 2.5 on the Hoehn and Yahr scale); - Allocation ratio is 1:1; - Randomization sequence of assigning samples to groups in each stratum: Given that each patient may enter the study at different times, before starting the allocation of samples, a random sequence is generated to randomly assign individuals to each of the study randomization strata based on the time of entry of individuals (first layer: B, B, A, B, A, B, A, B, A, B, A, B, B, A, A; second layer: A, B, B, A, A, A, A, B, B, B, A, B, B, B, A) - A: Intervention group; B: Control group - Concealment of the randomization sequence through a sealed envelope containing the name of the assigned group. The names of the randomization strata (first stratum and second stratum) are written on the envelope and the name of the intervention or control group is placed inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person responsible for conducting the assessments is someone other than the people implementing the therapeutic intervention sessions who is not aware of the study groups in terms of the type of therapeutic interventions. The person responsible for conducting the statistical analyses of the study is also someone other than the group implementing and evaluating the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8184667951
Approval date
2026-02-16, 1404/11/27
Ethics committee reference number
IR.MUI.NUREMA.REC.1404.174

Health conditions studied

1

Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
cognition
Timepoint
Pre-test, Post-test (one month after starting the intervention), follow-up (one month after ending intervention)
Method of measurement
The Cambridge Neuropsychological Test Automated Battery

2

Description
hand Function
Timepoint
Pre-test, Post-test (one month after starting the intervention), follow-up (one month after ending intervention)
Method of measurement
Box&Block test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group - Cognitive rehabilitation: The intervention group's treatment program will include cognitive rehabilitation for 10 one-and-a-half hour sessions, 3 days a week. In the first part of cognitive exercises, common cognitive problems of Parkinson's patients are targeted for treatment through the following exercises: 1. Elimination 2. Number sequences. 3. Problem clarification. 4. Communication. 5. Text comprehension. 6. Recall. 7. Word search. 8. Maze navigation. 9. Classification. 10. Action sequences. 11. Story memory. In the second part of cognitive exercises, cognitive exercises are performed in the form of daily life activities and based on a task-oriented approach in occupational therapy. To implement this approach, daily life activities that the individual has considered important and meaningful in his or her life in the initial assessment session and that have the ability to be implemented in the occupational therapy clinic environment are practiced.
Category
Rehabilitation

2

Description
Control group: The treatment program includes hand sensorimotor retraining for 10 one-and-a-half hour sessions, 3 days a week, plus cognitive rehabilitation for 10 one-and-a-half hour sessions, 3 days a week.Sensory-motor rehabilitation of the hand: Sensory-motor exercises of the hand for 45 minutes per session and sensory-motor exercises in the form of daily life activities based on a task-oriented approach in occupational therapy for 45 minutes per session. In the sensory-motor retraining exercises of the hand, sensory retraining exercises and motor retraining exercises are performed in combination with the help of various objects and equipment applied to sensory recovery, muscle strength, and range of motion. In the second part of the sensory-motor retraining exercises of the hand, sensory-motor exercises are performed in the form of daily life activities based on a task-oriented approach in occupational therapy. To implement this approach, daily life activities that the individual has considered important and meaningful in his or her life in the initial assessment session and that have the ability to be performed in the occupational therapy clinic environment are practiced.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, Kashani Hospital
Full name of responsible person
Hamid Reza Rostami
Street address
hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8184667951
Phone
+98 913 432 8034
Email
hrr.rostami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Deputy of Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8184667951
Phone
+98 913 432 8034
Email
hrr.rostami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
hamid Reza Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8184667951
Phone
+98 913 432 8034
Email
hrr.rostami@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
hamid reza rostami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8184667951
Phone
+98 913 432 8034
Email
hrr.rostami@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
hamid reza rostami
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
jezar jarib
City
Isfahan
Province
Isfehan
Postal code
8184667951
Phone
+98 913 432 8034
Email
hrr.rostami@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
6 months after the publication of the study results, the data of the individuals will be made available anonymously only to scientific and academic researchers, if needed.
When the data will become available and for how long
6 months after the publication of the study results
To whom data/document is available
scientific and academic researchers
Under which criteria data/document could be used
scientific and academic usages
From where data/document is obtainable
Hamid Reza Rostami Isfahan University of medical sciences email: hrr.rostami@gmail.com
What processes are involved for a request to access data/document
Email: hrr.rostami@gmail.com
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