Art Therapy and Its Effect on Motor Function Rehabilitation in the Subacute Phase of Stroke Recovery

The target disease of this study is subacute ischemic stroke, a condition characterized by reduced blood flow to brain tissue due to arterial blockage, with a specific focus on the subacute recovery phase. This phase typically occurs within days to weeks post-stroke, making it a critical period for rehabilitation interventions to optimize functional outcomes and improve long-term prognosis.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Art therapy; Behavioral: Regular therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zexi Liu; Phone Number: 17621611192; Email: doudou23946476@outlook.com

Study Locations

• China
  • Heilongjiang
    • Jiamusi, Heilongjiang, China, 156500
      • Recruiting
      • Fuyuan People's Hospital
      • Contact: Zexi Liu; Phone Number: 17621611192; Email: doudou23946476@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Study Participants: Stroke patients aged 40-75. Patients in this age group generally have a higher incidence of stroke and show relatively higher plasticity during the rehabilitation process.
2. Type of Stroke: First occurrence of ischemic or hemorrhagic stroke, confirmed by imaging (CT or MRI). This helps to ensure consistency in the type of stroke among participants, reducing rehabilitation differences caused by varying stroke types.
3. Time Since Stroke Onset: Between 2 weeks and 3 months post-stroke (broadly defined subacute phase). During this phase, patients have usually transitioned out of the acute treatment phase and exhibit significant plasticity in physical and psychological recovery, making it a critical period for rehabilitation.
4. Severity of Stroke Sequelae: Stroke sequelae should be mild to moderate (Modified Rankin Scale score of 2 to 3). These patients have some level of independent mobility but still require rehabilitation training to further improve function.
5. Cognitive Ability: Participants must have basic cognitive function and be able to understand and comply with research requirements. This ensures that patients can effectively participate in art therapy and accurately report subjective experiences.
6. Emotional Status: Participants' levels of depression, anxiety, or stress should be mild to moderate at the start of the study. Patients with severe psychological disorders may require more intensive psychological support, which falls outside the scope of this study.
7. Language and Communication Skills: Participants must possess basic language expression and comprehension abilities to engage in and understand interactions during art therapy sessions. This ensures effective communication with the therapist.
8. Physical Condition: Participants must have the basic physical functions necessary to participate in art therapy, such as the ability to perform simple limb movements and activities. Severe physical disabilities may prevent participation in art activities.
9. Living Environment: Participants should reside in an area that allows them to regularly travel to the treatment site and have a relatively stable living environment. This helps ensure that patients can attend each therapy session on time and complete the entire intervention cycle.
10. Consent to Participate: Both the patient and their family members must fully understand the purpose, process, and potential risks of the study and be willing to sign an informed consent form. This ensures that patients fully comprehend their responsibilities and rights when participating in the study.
11. No Prior Psychological or Art Therapy: Participants must not have received any form of psychological therapy, art therapy, or similar rehabilitation intervention in the past 6 months to exclude the impact of other interventions on the study results.

Exclusion Criteria:

Exclusion criteria：

1. Severe Mental Illness: A history or current diagnosis of severe mental disorders (e.g., schizophrenia, bipolar disorder) or a current severe level of depression, anxiety, or stress. These mental health issues may require specialized psychological treatment, which is not aligned with the intervention objectives of this study.
2. Severe Comorbidities: Patients with serious physical illnesses, such as advanced cancer, severe heart disease (e.g., heart failure, acute coronary syndrome), chronic renal failure, or severe chronic respiratory diseases. These conditions may severely affect the patient's ability to participate and the rehabilitation outcomes.
3. Severe Sensory Impairments: Patients with serious sensory impairments, such as blindness, profound hearing loss, or uncorrectable sensory deficits. These impairments may prevent effective participation in art therapy, especially in activities requiring visual or auditory engagement (such as painting or music therapy).
4. Severe Language Impairments: Patients with severe aphasia or speech communication disorders that impede effective communication or expression. This would affect the patient's ability to participate in and understand the therapy process.
5. Substance Dependence or Abuse History: Patients with a current history of substance dependence or abuse (including alcohol and illicit drugs). Such conditions may significantly impact cognitive and behavioral functions, potentially interfering with the study's intervention effects.
6. Allergies or Physical Discomfort: Patients with severe allergic reactions to materials potentially used in art therapy (e.g., paint, clay, musical instruments) or a history of physical discomfort caused by similar materials.
7. Lack of Willingness to Participate: Patients or their family members show insufficient willingness to participate in the study or are unable to provide written informed consent. This may lead to premature withdrawal, affecting the study's integrity and result analysis.
8. Other Potential Influencing Factors: Any other factors not listed but considered by researchers to potentially affect patient participation or study outcomes. For example, significant life events (e.g., bereavement, divorce), which may have a considerable impact on the patient's psychological state.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Art Therapy	Behavioral: Art therapy; Through music, painting, dance and other forms, art therapy can not only help patients regulate their emotions, relieve anxiety and depression, but also activate different areas of the brain to promote neuroplasticity, thereby promoting the recovery of motor function
Active Comparator: Regular therapy	Behavioral: Regular therapy; Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.	1 month

Collaborators and Investigators

• Sponsor: Chonbuk National University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: MR-23-24-048933

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No