NCT05322915

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 4, 2022

Last Update Submit

April 4, 2022

Conditions

Keywords

line dancebalanceanxietydepressionquality of lifeMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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)

    4 weeks

Secondary Outcomes (2)

  • Hospital Anxiety and Depression Scale

    4 weeks

  • Multiple Sclerosis Quality of Life-54

    4 weeks

Study Arms (2)

dance group

EXPERIMENTAL

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

Other: line dancing

control

NO INTERVENTION

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

Interventions

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.

dance group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Gamze Ekici Çağlar, Prof

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

June 1, 2021

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

There isn't a plan to make IPD and related data dictionaries available.

Locations