- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06145503
Dance Intervention on Cognitive Functions and Quality of Life in Chronic Stroke
The Effect of Dance Intervention on Cognitive Functions and Quality of Life in Patients With Chronic Stroke: A Single-Blind Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is a prevalent medical condition, primarily affecting individuals aged 65 and older. However, it can also strike young people and even children and ranks as the second leading cause of non-traumatic disability and cognitive impairment among adults. Stroke can lead to a range of physical, sensory, and cognitive deficits and impairments in psychosocial functioning. One of the most significant challenges faced by stroke survivors is cognitive impairment. The prevalence of cognitive impairment following a stroke varies widely, ranging from 20% to 80%, and it is influenced by factors such as geographical location, ethnicity, and diagnostic criteria. Stroke can disrupt various cognitive functions, including information processing, memory, planning, problem-solving, spatial awareness, apraxia, motor control, spatial perception, confusion, denial (anosognosia), and object recognition issues (agnosia). The literature reports that 30% of stroke patients experience functional limitations related to balance, speech, and cognitive issues. Particularly, more than half of stroke patients over the age of 65 experience hemiparesis, and around 30% require assistance for walking. Chronic stroke can also lead to balance and mobility problems, affecting daily life activities and significantly impacting the patient's overall quality of life.
There is a growing need for improvements in the post-stroke experience and long-term care for stroke patients. In this context, rehabilitation interventions play a vital role. Rehabilitation interventions aim to prevent complications, reduce neurological deficits, maximize functional capacity, and ultimately promote personal autonomy and social integration. Dance intervention, as part of the rehabilitation process, is recognized as an effective approach to addressing chronic stroke-related motor disorders, positively impacting post-stroke health, and promoting socialization. Dance, characterized by rhythmic body movements to music, serves as a form of artistic or emotional expression and can be performed individually, in pairs, or in groups. It is a multifaceted activity that engages both physical and cognitive abilities. Dance has been found to have positive effects on emotions, sensory stimulation, motor coordination, social interaction, perception, executive functions, and memory. Literature suggests that dance intervention helps to improve both the physical and cognitive impairments of stroke patients through promoting interpersonal harmony and multiple stimulations, and therefore its use is recommended to enhance the cognitive and physical functions of chronic stroke patients. In light of this information, this single-blind, randomized, controlled study aims to investigate the impact of dance intervention on cognitive functions and quality of life among chronic stroke patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trabzon, Turkey, 61800
- Karadeniz Tecnical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Being over 18 years of age,
- Volunteering to participate in the study,
- Clear consciousness and be able to communicate,
- Hemorrhagic or ischemic stroke at least 6 months ago,
- Ability to walk 10 meters without physical assistance and tolerate 50 minutes of exercise,
- Standing, maintaining balance,
- Not having had more than one stroke attack,
- A score of 21 or lower on the Montreal Cognitive Assessment Scale (MoCA).
Exclusion criteria Exclusion criteria were not meeting the inclusion criteria, having a known psychological disorder, having orthopedic disorders, having severe cognitive impairment, having an affected gait and balance, having undergone a recent surgical operation, having hearing loss, and having additional neurological diseases other than stroke.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dance Intervention Group
Patients within the dance intervention group (n=20) were initially required to complete a "Patient Information Form" and provide written informed consent following an explanation of the study.
Over the course of 12 weeks, these patients (n=20) received a 60-minute dance intervention three times a week, led by a dance instructor.
Assessments, including the "MoCA" and "SS-QOL," were conducted three times: before the dance intervention (pre-test/0th week), at the 6th week (interim measurement), and after completing the 12-week study (post-test/12th week).
|
The dance sessions, tailored to participants' preferences, were accompanied by music from the 80s and 90s.
A dance instructor demonstrated each dance step, and the sessions comprised a 10-minute warm-up, 40 minutes of dancing, and a 10-minute cool-down.
The complexity and intensity of the dance routines were adjusted based on individual abilities, functional variations, and capacity.
|
|
No Intervention: Control Group
The control group did not receive any intervention beyond participating in data collection.
Patients in this group underwent assessments with the "MoCA" and "SS-QOL" before the study (pre-test/0th week), at the 6th week of the study (interim measurement), and after the completion of the 12-week study (post-test/12th week).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Montreal Cognitive Assessment
Time Frame: 12 Weeks
|
The Montreal Cognitive Assessment (MoCA) is a cognitive assessment tool designed to evaluate cognitive functions, especially in the early stages of cognitive impairment. The MoCA scale is scored between 0 and 30 points, with higher scores indicating better cognitive functioning. A significant increase was found in the "MoCA" general score averages in the dance intervention group. |
12 Weeks
|
|
The Stroke Specific Quality of Life Scale
Time Frame: 12 Weeks
|
The "Stroke Specific Quality of Life Scale (SS-QOL)" is a five-point Likert-type scale (1 point = "Strongly agree" - 5 points = "Strongly disagree"). The total score of the scale is calculated by summing the average scores from each of the 12 domains and dividing by 12. A higher total scale score signifies a higher quality of life, while a lower score indicates a lower quality of life. The mean scores of the dance intervention group on the activities, social and family roles, language, energy, mood, personality, thinking sub-dimensions, and total of the SS-QOL increased significantly from pre-test to post-test. |
12 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCS20062023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Dance Intervention Group
-
Louisiana State University and A&M CollegeCompletedPhysical Activity | Stress | Anxiety | Depression Secondary to Other DiseaseUnited States
-
National University of SingaporeLions BefriendersCompleted
-
Education University of Hong KongThe Hong Kong Society for RehabilitationNot yet recruitingPhysial DisabilitiesHong Kong
-
University Health Network, TorontoHeart and Stroke Foundation of CanadaUnknown
-
North Essex Partnership NHS Foundation TrustUniversity College, London; West Essex Clinical Commissioning Group; School for...CompletedStroke | Diabetes Mellitus | Dementia | Mild Cognitive Impairment | Cardiac DiseasesUnited Kingdom
-
Federal University of MaranhaoActive, not recruitingBreast Cancer | Breast - Female | Breast Cancer FemalesBrazil
-
University of LimerickCompleted
-
Federal University of São PauloCompleted
-
McMaster UniversityRecruitingFrailty | Frailty Syndrome | Frail Older Adults | Frailty in AgingCanada