StrokeNCT06709950
Art Therapy and Its Effect on Motor Function Rehabilitation in the Subacute Phase of Stroke Recovery
A study testing Art therapy and Regular therapy in people with Stroke, run by Chonbuk National University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Art therapy and Regular therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuyuan People's Hospital
Jiamusi, Heilongjiang, 156500
Zexi Liu, 17621611192, doudou23946476@outlook.com
About this study
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.
- Conditions
- Stroke
- Being tested
- Art therapy, Regular therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapyBehavioural
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
Regular therapyBehavioural
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Not described Receives: Behavioral: Art therapy |
| Regular therapy | Active comparator | Not described Receives: Behavioral: Regular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start15 Nov 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zexi Liu, Chonbuk National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709950
- Sponsor's protocol ID
- MR-23-24-048933
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy and Its Effect on Motor Function Rehabilitation in the Subacute Phase of Stroke Recovery
- ClinicalTrials.gov ID
- NCT06709950
- Acronym / sponsor ID
- MR-23-24-048933
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chonbuk National UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Behavioral: Art therapy |
| Regular therapy | Active comparator | Behavioral: Regular therapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
- 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.
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
- 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).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art therapyThrough 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 | Behavioural | Art Therapy |
| Regular therapyStandard treatment | Behavioural | Regular therapy |
Primary outcome
Fugl-Meyer Assessment
Time frame: 1 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy and Regular therapy in people with Stroke, run by Chonbuk National University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zexi Liu (17621611192, doudou23946476@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.