Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Movement and Music Intervention for Individuals With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03121950
Recruitment Status : Unknown
Verified April 2017 by Deb Kegelmeyer, Ohio State University.
Recruitment status was:  Recruiting
First Posted : April 20, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Deb Kegelmeyer, Ohio State University

Brief 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 either a dance class or listen to live music. The study includes assessments of walking, balance and cognition.

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Dementia Other: Dance Other: music Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be placed in one of two groups. One group will participate 2 times a week in a dance class. The other group will listen to live music once a week.
Masking: Single (Outcomes Assessor)
Masking Description: The primary assessor will be blinded to group
Primary Purpose: Treatment
Official Title: Movement and Music Intervention for Individuals With Dementia
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Dance in dementia
examine if participating in a dance class improves mobility and/or cognition in individuals with dementia.
Other: Dance
The primary intervention is a dance class

Experimental: Music and dementia
examine if listening to music improves mobility and/or cognition in individuals with dementia.
Other: music
the secondary intervention is listening to live music




Primary Outcome Measures :
  1. Change in time to complete the Timed up and go cognitive [ Time Frame: 12 weeks ]
    a measure of walking time while performing a concurrent cognitive task


Secondary Outcome Measures :
  1. Change in score on the Montreal Cognitive Assessment [ Time Frame: 12 weeks ]
    An assessment of overall cognitive status


Other Outcome Measures:
  1. change in score on the caregiver burden [ Time Frame: 12 weeks ]
    a questionnaire asking caregivers about the impact of caregiving on daily life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of dementia
  • Mini-Mental State Examinationscore > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121950


Contacts
Layout table for location contacts
Contact: Deb Kegelmeyer, DPT 614-293-0214 deb.kegelmeyer@osumc.edu
Contact: Raquel Minarsch, PT 614-688-5926 raquel.minarsch@osumc.edu

Locations
Layout table for location information
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Deb Kegelmeyer, DPT    614-293-0214    deb.kegelmeyer@osumc.edu   
Contact: Raquel Minarsch    614-688-5926    raquel.minarsch@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: Deb Kegelmeyer, DPT Ohio State University

Layout table for additonal information
Responsible Party: Deb Kegelmeyer, Professor Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03121950     History of Changes
Other Study ID Numbers: 2016H0211
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deb Kegelmeyer, Ohio State University:
dementia

Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Alzheimer Disease
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders