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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03121950
Other study ID # 2016H0211
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date December 30, 2017

Study information

Verified date September 2020
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.


Description:

Dementia impacts 5%-7% of individuals >60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 30, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of dementia

- Mini-Mental State Examination score > 9

- Age > 60 years

- Able to follow simple instructions

Exclusion Criteria:

- Unable to walk 10 feet unassisted

- Presence of orthopedic disorder that impacts walking

- Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury

Study Design


Intervention

Other:
Dance
The primary intervention is a dance class
Music
the secondary intervention is listening to live music

Locations

Country Name City State
United States Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Score on the Caregiver Burden Scale A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden. 12 weeks
Primary Timed up and go Cognitive The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes. 12 weeks
Secondary Change in Score on the Montreal Cognitive Assessment The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function. 12 weeks
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