Multiple SclerosisNCT05322915
Therapeutic Effects of Line Dancing in People With MS
A study testing line dancing in people with Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- line dancing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-65 years,
- EDSS [22]<6,
- Mini-Mental State Examination score >24.
Who cannot join
- exacerbations within the previous three months,
- have other physical, neurological problems,
- changeable health status.
- havig a cardiovascular disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Line Dancing in People With Multiple Sclerosis: an Evaluator-blinded, Randomized Controlled Study
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- line dancing
- Keywords
- line dance, balance, anxiety, depression, quality of life, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
line dancingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| dance group | Experimental | The dance group, each patient received a goal-oriented line dancing program. Receives: Other: line dancing |
| control | No intervention | The control group did not receive any treatment program during this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Jun 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Fenerbahce University
- Responsible party
- Principal investigator, FATOS KIRTEKE, Gazi University
- Investigators
- Gamze Ekici Çağlar, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322915
- Sponsor's protocol ID
- Hacettepe Ergotherapy
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There isn't a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Line Dancing in People With Multiple Sclerosis: an Evaluator-blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05322915
- Acronym / sponsor ID
- Hacettepe Ergotherapy
- Conditions
- Multiple Sclerosis
- Keywords
- line dance, balance, anxiety, depression, quality of life, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University, Fenerbahce University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dance group | Experimental | Other: line dancingThe dance group, each patient received a goal-oriented line dancing program. |
| control | No intervention | –The control group did not receive any treatment program during this period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18-65 years,
- EDSS [22]<6,
- Mini-Mental State Examination score >24.
Key exclusion criteria (4 listed)
- exacerbations within the previous three months,
- have other physical, neurological problems,
- changeable health status.
- havig a cardiovascular disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| line dancingThe 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. | Other | dance group |
Primary outcome
Berg Balance Scale
Time frame: 4 weeks
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)
2 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: 4 weeks
Multiple Sclerosis Quality of Life-54
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No. There isn't a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Ekici Çağlar, Prof study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing line dancing in people with Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.