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NCT Number: NCT07702929

Effect of Hand Rehabilitation on Cognitive Function in Patients With PD

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Hand Sensorimotor Rehabilitation

Other

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

Cognitive Remediation

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hamid Reza Rostami, PhD

CONTACT

[email protected]

00989134328034

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Effect of Sensory-motor Rehabilitation of the Hand on Cognitive Functions in Patients With Parkinson's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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