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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06145503
Other study ID # RCS20062023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date January 1, 2024

Study information

Verified date February 2024
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To examine the effect of dance interventions on cognitive functions and quality of life in patients with chronic stroke.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

Device:
Dance Intervention Group
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.

Locations

Country Name City State
Turkey Karadeniz Tecnical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Montreal Cognitive Assessment 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
Primary The Stroke Specific Quality of Life Scale 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
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