- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05322915
Therapeutic Effects of Line Dancing in People With MS
Therapeutic Effects of Line Dancing in People With Multiple Sclerosis: an Evaluator-blinded, Randomized Controlled Study
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: dance group
The dance group, each patient received a goal-oriented line dancing program.
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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.
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No Intervention: control
The control group did not receive any treatment program during this period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Berg Balance Scale
Time Frame: 4 weeks
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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)
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hospital Anxiety and Depression Scale
Time Frame: 4 weeks
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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.
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4 weeks
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Multiple Sclerosis Quality of Life-54
Time Frame: 4 weeks
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It was developed specifically to assess the quality of life of PwMS.
It includes 12 parts and 54 questions.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gamze Ekici Çağlar, Prof, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hacettepe Ergotherapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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