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

NCT06145503 | Completed

• 1 other identifier: RCS20062023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Impairment; Stroke; Quality of Life

Keywords

Cognitive impairment; Dance; Stroke; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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).

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).

Interventions

Dance Intervention Group DEVICE

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.

Dance Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Tecnical University

Trabzon, 61800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this single-blind, randomized, controlled clinical trial, certain measures were taken to minimize bias throughout the study. The researcher responsible for collecting data from the participants with chronic stroke was unaware of the patient's allocation to either the intervention or control groups. Simultaneously, the principal investigator in charge of the dance intervention group remained blinded to the initial assessments conducted for both the dance intervention and control groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 24, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)