Cognitive ImpairmentNCT06145503
Dance Intervention on Cognitive Functions and Quality of Life in Chronic Stroke
A study testing Dance Intervention Group in people with Cognitive Impairment and Stroke, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
To examine the effect of dance interventions on cognitive functions and quality of life in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cognitive Impairment, Stroke, Quality of Life
- What is being tested?
- Dance Intervention Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dance Intervention on Cognitive Functions and Quality of Life in Patients With Chronic Stroke: A Single-Blind Randomized Controlled Study
To examine the effect of dance interventions on cognitive functions and quality of life in patients with chronic stroke.
Read the 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.
- Conditions
- Cognitive Impairment, Stroke, Quality of Life
- Being tested
- Dance Intervention Group
- Keywords
- Cognitive impairment, Dance, Stroke, Quality of life
- Medical subject headings
- Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Intervention GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance Intervention Group | Experimental | 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). Receives: Device: Dance Intervention Group |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size was determined as 36 chronic stroke patients in total (18 for each group) for the two groups (dance intervention group, control group) with an effect size of 1,000 and a targeted test power of 0.90 (90%) in the G\*Power 3.1.9.6 program with an error of α=0.05 and a reference to a previous study on the subject. During the course of the research, and in anticipation of potential dropouts or patient mortality, the sample size for each group was increased, resulting in a total of 40 chronic stroke patients, with 20 patients in each group, being included in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Demirağ, Ph.D, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145503
- Sponsor's protocol ID
- RCS20062023
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I'll decide later
Publications
Cin A, Demirag H PhD, MSc, RN, Hintistan S PhD, MSc, RN. The effect of dance intervention on cognitive functions and quality of life in patients with Chronic Stroke: A single-blind, randomized controlled trial. Geriatr Nurs. 2026 Apr;69:103948. doi: 10.1016/j.gerinurse.2026.103948. Epub 2026 Feb 23.
PubMed 41734404
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dance Intervention on Cognitive Functions and Quality of Life in Patients With Chronic Stroke: A Single-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06145503
- Acronym / sponsor ID
- RCS20062023
- Conditions
- Cognitive Impairment, Stroke, Quality of Life
- Keywords
- Cognitive impairment, Dance, Stroke, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 24 Nov 2023 (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.
To examine the effect of dance interventions on cognitive functions and quality of life in patients with chronic stroke.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample size was determined as 36 chronic stroke patients in total (18 for each group) for the two groups (dance intervention group, control group) with an effect size of 1,000 and a targeted test power of 0.90 (90%) in the G*Power 3.1.9.6 program with an error of α=0.05 and a reference to a previous study on the subject. During the course of the research, and in anticipation of potential dropouts or patient mortality, the sample size for each group was increased, resulting in a total of 40 chronic stroke patients, with 20 patients in each group, being included in the study.
| Arm | Type | Receives |
|---|---|---|
| Dance Intervention Group | Experimental | Device: Dance Intervention GroupPatients 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). |
| Control Group | No intervention | –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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dance Intervention GroupThe 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. | Device | Dance Intervention Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 41734404Cin A, Demirag H PhD, MSc, RN, Hintistan S PhD, MSc, RN. The effect of dance intervention on cognitive functions and quality of life in patients with Chronic Stroke: A single-blind, randomized controlled trial. Geriatr Nurs. 2026 Apr;69:103948. doi: 10.1016/j.gerinurse.2026.103948. Epub 2026 Feb 23.
- Individual participant dataSharing planned: No. I'll decide later
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Intervention Group in people with Cognitive Impairment and Stroke, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 9 inclusion and 0 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: finished, as of the sponsor's last update on 7 Feb 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Montreal Cognitive Assessment (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145503, which also lists 1 linked publication.
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 7 Feb 2024.