Dance Intervention on Cognitive Functions and Quality of Life in Chronic Stroke

February 6, 2024 updated by: Hatice Demirağ, Ph.D, Karadeniz Technical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61800
        • Karadeniz Tecnical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCS20062023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I'll decide later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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