Effect of Art Therapy on Cognitive and Hand Functions of Alzheimer's Patients
Phase: NA
Conditions: Alzheimer Disease
Sponsor: Fenerbahce University

                                                                                                                  30.06.2025 
 
Effect of Art Therapy on Cognitive and Hand Functions of Alzheimer's Patients 
Study Protocol 
1. Introduction 
This study aims to evaluate the effects of art therapy on cognitive and hand functions in 
patients diagnosed with mild to moderate Alzheimer’s disease. Alzheimer’s disease is a 
progressive neurodegenerative disorder characterized by decline in memory, attention, 
executive functions, and daily living activities. Art therapy, involving visual and creative 
activities such as painting, collage, and clay modeling, may contribute to cognitive 
stimulation, fine motor skills, and neuroplasticity. 
2. Objectives 
Primary Objective: To investigate the effect of art therapy on cognitive functions in 
Alzheimer’s patients. 
Secondary Objective: To examine the effect of art therapy on hand functions and fine motor 
skills. 
3. Study Design 
This is a randomized controlled trial (RCT). Participants will be randomly assigned to either 
an intervention group (art therapy) or a control group (no intervention). The study 
duration is 8 weeks, with sessions held twice weekly, each lasting 60 minutes. 
4. Participants 
Inclusion Criteria: 
• Being 60 years of age or older 
• Having a diagnosis of mild or moderate Alzheimer’s disease 
• Possessing the physical and cognitive capacity to participate in art therapy interventions 
• Providing informed consent 
Exclusion Criteria: 
• Being in the severe stage of Alzheimer’s disease 
• Having a history of severe psychiatric disorders such as schizophrenia or major 
depression 
• Having a physical disability that prevents the use of the upper extremities 
• Being unable to participate in the intervention due to visual or hearing impairments 

5. Sample Size and Randomization 
Sample size calculation was performed using G*Power 3.1. Assuming an effect size of 0.5, α 
= 0.05, and power (1-β) = 0.80, a total of 44 participants (22 per group) are required. To 
account for potential dropouts, the target sample size is 50. Randomization will be 
conducted using a computer-generated sequence with allocation concealment via sealed 
envelopes. 
6. Intervention 
The intervention group will receive art therapy sessions over 8 weeks, twice weekly, each 
lasting 60 minutes. The program includes mandala coloring (weeks 1–2), collage making 
(weeks 3–4), clay modeling (weeks 5–6), free drawing/painting (week 7), and a 
participant’s choice activity (week 8). The control group will not receive any intervention. 
7. Outcome Measures 
• Mini-Mental State Examination (MMSE): to assess global cognitive function 
• Surface Electromyography (sEMG): to measure forearm muscle activity during hand tasks 
• Nine-Hole Peg Test (NHPT): to evaluate fine motor skills and hand dexterity 
 
8. Data Collection 
Assessments will be conducted at baseline (pre-test) and after the 8-week intervention 
(post-test). All evaluations will be performed by blinded assessors. 
9. Statistical Analysis 
Data will be analyzed using IBM SPSS Statistics 22. Descriptive statistics (mean, standard 
deviation, frequency, percentage) will be used to summarize demographic and clinical data. 
Normality of distribution will be tested using the Shapiro-Wilk test. For within-group 
comparisons (pre- and post-intervention), paired t-tests (parametric) or Wilcoxon signed-
rank tests (non-parametric) will be used. For between-group comparisons, independent 
samples t-tests (parametric) or Mann–Whitney U tests (non-parametric) will be applied. 
Effect sizes (Cohen’s d or r) will be calculated to assess the magnitude of changes. Statistical 
significance will be set at p < 0.05. 
10. Ethics 
The study protocol has been reviewed and approved by the Fenerbahçe University Non-
Interventional Clinical Research Ethics Committee. Written informed consent will be 
obtained from all participants or their legal guardians.