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Therapeutic Effects of Line Dancing in People With MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
line dancing
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring line dance, balance, anxiety, depression, quality of life, Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18-65 years,
  • EDSS [22]<6,
  • Mini-Mental State Examination score >24.

Exclusion Criteria:

  • exacerbations within the previous three months,
  • have other physical, neurological problems,
  • changeable health status.
  • havig a cardiovascular disorder

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

dance group

control

Arm Description

The dance group, each patient received a goal-oriented line dancing program.

The control group did not receive any treatment program during this period.

Outcomes

Primary Outcome Measures

Berg Balance Scale
On the scale which consists of 14 questions, individuals are given points between 0 and 4 for each question. High scores indicate good balance and low scores indicate poor balance (41-56=independent, 21-40=walks with assistance, 0-20=dependent)

Secondary Outcome Measures

Hospital Anxiety and Depression Scale
The scale consists of 14 items, 7 of which investigate symptoms of anxiety and 7 of which investigate symptoms of depression. The scale is evaluated between 0-3 points. The cut-off value for anxiety is 10/11, and the cut-off value for depression is 7/8.
Multiple Sclerosis Quality of Life-54
It was developed specifically to assess the quality of life of PwMS. It includes 12 parts and 54 questions.

Full Information

First Posted
April 4, 2022
Last Updated
April 4, 2022
Sponsor
Gazi University
Collaborators
Hacettepe University, Fenerbahce University
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1. Study Identification

Unique Protocol Identification Number
NCT05322915
Brief Title
Therapeutic Effects of Line Dancing in People With MS
Official Title
Therapeutic Effects of Line Dancing in People With Multiple Sclerosis: an Evaluator-blinded, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Hacettepe University, Fenerbahce University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to analyze the effects of line dancing on balance, anxiety, depression and quality of life for people with multiple sclerosis (PwMS).
Detailed Description
Purpose: The objective of this study is to analyze the effects of line dancing on balance, anxiety, depression and quality of life for people with multiple sclerosis (PwMS). Methods: This study was conducted prospective parallel-group design study. 31 PwMS were randomized two groups. The dance group undertook 60-minute sessions twice a week for four weeks and the control group did not do any particular training during this period. The outcome were measured using the Berg Balance Scale (BBS), Hospital Anxiety and Depression Scale (HADS), and Multiple Sclerosis Quality of Life-54 (MSQoL-54) by an evaluator blinded to the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
line dance, balance, anxiety, depression, quality of life, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dance group
Arm Type
Experimental
Arm Description
The dance group, each patient received a goal-oriented line dancing program.
Arm Title
control
Arm Type
No Intervention
Arm Description
The control group did not receive any treatment program during this period.
Intervention Type
Other
Intervention Name(s)
line dancing
Intervention Description
The intervention included 60-minute sessions, two days a week for four weeks for a total of eight sessions. All sessions were administered by the physiotherapist who has 26 years of experience in dance therapy. The dance was performed on a one to one basis with minimal support from the therapist. The line dancing sequence, which was specially created for this training program, was designed as a structured goal-oriented dance. Line dancing movements/steps are comprised of moving forward and backward, or sideways and turns and scuff. In addition, the fact that one foot is always in contact with the ground makes it ideal for patients with multiple sclerosis, who may have balance problems.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
On the scale which consists of 14 questions, individuals are given points between 0 and 4 for each question. High scores indicate good balance and low scores indicate poor balance (41-56=independent, 21-40=walks with assistance, 0-20=dependent)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
The scale consists of 14 items, 7 of which investigate symptoms of anxiety and 7 of which investigate symptoms of depression. The scale is evaluated between 0-3 points. The cut-off value for anxiety is 10/11, and the cut-off value for depression is 7/8.
Time Frame
4 weeks
Title
Multiple Sclerosis Quality of Life-54
Description
It was developed specifically to assess the quality of life of PwMS. It includes 12 parts and 54 questions.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 18-65 years, EDSS [22]<6, Mini-Mental State Examination score >24. Exclusion Criteria: exacerbations within the previous three months, have other physical, neurological problems, changeable health status. havig a cardiovascular disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Ekici Çağlar, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There isn't a plan to make IPD and related data dictionaries available.

Learn more about this trial

Therapeutic Effects of Line Dancing in People With MS

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