PARKINSON DISEASE (Disorder)NCT07702929
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
A study testing Hand Sensorimotor Rehabilitation and Cognitive Remediation in people with PARKINSON DISEASE (Disorder), run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Hand Sensorimotor Rehabilitation and Cognitive Remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- 23 Aug 2026to 23 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
- 45-65 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.
Who cannot join
- Patients with neurological diseases other than PD
- Patients with orthopedic and internal diseases that would make participation in the study difficult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan, Isfahan, 8184667951
About this study
Official title: 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 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)
- Being tested
- Hand Sensorimotor Rehabilitation, Cognitive Remediation
- Keywords
- Cognition, Hand Function, Parkinson's Disease, Occupational Therapy, Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Sensorimotor RehabilitationOther
10 one-and-a-half-hour sessions, 3 sessions per week
Cognitive RemediationOther
10 one-and-a-half-hour sessions, 3 sessions per week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Hand Sensorimotor Rehabilitation; Other: Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: - 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.
Measured: - 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
Measured: - 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.
Measured: - 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
Measured: - 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.
Measured: - 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.
Measured: - 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.
Measured: - 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.
Measured: - The day before starting intervention - The day after ending intervention - One month after ending intervention
Pinch gauge
This tool measures fine fingertip grip strength
Measured: - 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
Measured: - 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
Measured: - The day before staring intervention - The day after ending intervention - one month after ending intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start23 Aug 2026
- Primary completion23 Jul 2027 (estimated)
- Study completion23 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Reza Rostami, Isfahan University of Medical Sciences
- Investigators
- Hamid Reza Rostami, PhD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702929
- Sponsor's protocol ID
- 2404210
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory-motor Rehabilitation of the Hand on Cognitive Functions in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07702929
- Acronym / sponsor ID
- 2404210
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Cognition, Hand Function, Parkinson's Disease, Occupational Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 23 Aug 2026 (actual)
- Primary completion
- 23 Jul 2027 (estimated)
- Study completion
- 23 Nov 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Sensorimotor Rehabilitation | Experimental | Other: Hand Sensorimotor RehabilitationThe 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. |
| Cognitive Rehabilitation | Active comparator | Other: Hand Sensorimotor Rehabilitation, Other: Cognitive RemediationThe 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
- 45-65 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;
Key exclusion criteria (2 listed)
- Patients with neurological diseases other than PD
- Patients with orthopedic and internal diseases that would make participation in the study difficult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Sensorimotor Rehabilitation10 one-and-a-half-hour sessions, 3 sessions per week | Other | Cognitive Rehabilitation, Hand Sensorimotor Rehabilitation |
| Cognitive Remediation10 one-and-a-half-hour sessions, 3 sessions per week | Other | Cognitive Rehabilitation |
Primary outcome
Montreal Cognitive Assessment
Time frame: - 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
Cambridge Neuropsychological Test Automated Battery - Reaction Time
Time frame: - 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.
Cambridge Neuropsychological Test Automated Battery - Spatial Span Test
Time frame: - 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
Cambridge Neuropsychological Test Automated Battery - Match to Sample Visual Search Test
Time frame: - 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.
Cambridge Neuropsychological Test Automated Battery - Stop Signal Task
Time frame: - 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
KING'S PD Pain Scale
Time frame: - 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.
Box & Block Test
Time frame: - 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 Purdue Pegboard Test
Time frame: - 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.
Hand Dynamometer Hydraulic Jamar
Time frame: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This tool measures hand grip strength.
Pinch gauge
Time frame: - The day before starting intervention - The day after ending intervention - One month after ending intervention
This tool measures fine fingertip grip strength
Semmes-Weinstein monofilaments
Time frame: - The day before staring intervention - The day after ending intervention - one month after ending intervention
This test assesses the tactile pressure perception threshold
The Michigan Hand Outcome Questionnaire
Time frame: - 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamid Reza Rostami, PhD principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Sensorimotor Rehabilitation and Cognitive Remediation in people with PARKINSON DISEASE (Disorder), run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: - The day before the intervention - The day after the intervention - One month after the last intervention session). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.