Clinical trial NCT06709950: Art Therapy and Its Effect on Motor Function Rehabilitation in the Subacute Phase of Stroke Recovery
Official title: Art Therapy and Its Effect on Motor Function Rehabilitation in the Subacute Phase of Stroke Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jiamusi
country: China
facility: Fuyuan People's Hospital
state: Heilongjiang
Study officials:
References: