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Not yet recruitingNCT07702929Updated Jul 24, 2026

Effect of Hand Rehabilitation on Cognitive Function in Patients With PD

An interventional study of Hand Sensorimotor Rehabilitation and Cognitive Remediation in PARKINSON DISEASE (Disorder), sponsored by Isfahan University of Medical Sciences. Not yet recruiting. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Isfahan University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • PARKINSON DISEASE (Disorder)

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Keywords

  • Cognition
  • Hand Function
  • Parkinson's Disease
  • Occupational Therapy
  • Rehabilitation
03

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
  2. 45-65 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • 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

  • 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 · Other: Cognitive Remediation

Interventions

  • OtherHand Sensorimotor Rehabilitation

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

  • OtherCognitive Remediation

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: - The day before the intervention - The day after the intervention - One month after the last intervention session

  2. 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.

    Time frame: - The day before the intervention - The day after the intervention - One month after the last intervention session

  3. 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

    Time frame: - The day before the intervention - The day after the intervention - One month after ending intervention

  4. 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.

    Time frame: - The day before the intervention - The day after the intervention - One month after the last intervention session

  5. 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

    Time frame: - The day before the intervention - The day after the intervention - One month after the last intervention session

  6. KING'S PD Pain Scale

    this tool measures pain which is specifically designed for patients with PD.

    Time frame: - The day before staring intervention - The day after ending intervention - one month after ending intervention

  7. 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.

    Time frame: - The day before starting intervention - The day after ending intervention - One month after ending intervention

  8. The Purdue Pegboard Test

    This test assesses fine motor skills and hand-eye coordination. The assembly subtest will considered in the present study.

    Time frame: - The day before starting intervention - The day after ending intervention - One month after ending intervention

  9. Hand Dynamometer Hydraulic Jamar

    This tool measures hand grip strength.

    Time frame: - The day before starting intervention - The day after ending intervention - One month after ending intervention

  10. Pinch gauge

    This tool measures fine fingertip grip strength

    Time frame: - The day before starting intervention - The day after ending intervention - One month after ending intervention

  11. Semmes-Weinstein monofilaments

    This test assesses the tactile pressure perception threshold

    Time frame: - The day before staring intervention - The day after ending intervention - one month after ending intervention

  12. The Michigan Hand Outcome Questionnaire

    It measures the individual's own perspective on overall hand function

    Time frame: - The day before staring intervention - The day after ending intervention - one month after ending intervention

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07702929
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Hamid Reza Rostami (Dr. Hamid Reza Rostami, Isfahan University of Medical Sciences) — Principal investigator
First posted
Jul 14, 2026
Start date
Aug 23, 2026 (estimated)
Primary completion
Jul 23, 2027 (estimated)
Completion
Nov 23, 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

Hamid Reza Rostami, PhD
Contact
hrr.rostami@gmail.com
00989134328034
Hamid Reza Rostami, PhD
principal investigator · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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