About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Patients with neurological diseases other than PD
Patients with orthopedic and internal diseases that would make participation in the study difficult
Trial design
Parallel
Treatments tested in this trial
Hand Sensorimotor Rehabilitation
Other intervention10 one-and-a-half-hour sessions, 3 sessions per week
Cognitive Remediation
Other intervention10 one-and-a-half-hour sessions, 3 sessions per week
Treatment groups
Trial outcomes
Primary outcomes
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
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.
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
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.
Locations
Sponsors and contacts
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