- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156735
Music Therapy on Cognition in Neurorehabilitation
The Effect of Music Therapy on Cognition in Neurorehabilitation - A Feasibility Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.
Thirty subjects participated in this study. Each participant received one session of each of the following: active music therapy intervention, passive music therapy intervention, and standard card. Mini-Cog tests were conducted before and after each session and the scores were collected for data analysis. Throughout the study, observations ensured the troubleshooting of any potential flaws for future recommendations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Malacca
-
Malaca, Malacca, Malaysia, 75450
- SOSCO Rehabilitation Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- NeuroRehabilitation Needs
Exclusion Criteria:
- obtain a score of above 22 or below 10 on the MMSE
- have documented current/active episodes of hallucinations and/or delusions
- have documented hearing impairments with or without hearing aid(s)
- have language barrier, i.e. do not speak or understand English, Mandarin or Malay
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Passive Music Therapy (P)
The therapist read a standardized relaxation script in the research participant's selected preferred language while improvising on the keyboard.
The script was inclusive of deep breathing and imagining a positive image.
The research participants were asked to close his or her eyes while relaxing and imagining.
The entire intervention lasted approximately 15 minutes.
The research participants were allowed to request to stop the intervention at any time
|
Music Therapy Intervention
|
|
Experimental: Active Music Therapy (A)
The research participants were given a standardized assortment of percussion instruments to choose from.
The therapist provided instructions of playing instruments along with the therapist.
The research participant was allowed to change his or her instrument at any time and was advised to sing along with the therapist.
Based on the research participant's age, the therapist selected the songs to sing and accompany on either the guitar or the keyboard.
The duration of the intervention was approximately 15 minutes, which allowed about five to six songs to be sung.
The research participants were allowed to request to repeat or skip any of the songs at any time.
|
Music Therapy Intervention
|
|
Active Comparator: Standard Care Control Condition (C)
The control condition involved mundane activities such as chatting, resting, or reading magazines, with the MT, in the treatment room.
|
Without any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Cog™ test
Time Frame: 1 year
|
The Friedman test was conducted to determine whether Mini-Cog test scores differ from P, A, and C. A score of 0-2 suggests a higher likelihood of significant cognitive impairment, while a score of 3-5 indicates a lower likelihood of dementia but does not exclude mild impairment.
|
1 year
|
Collaborators and Investigators
Sponsor
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
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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