NCT06156735

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

August 2, 2023

Last Update Submit

April 8, 2025

Conditions

Keywords

Music therapyActivePassiveneurorehabilitation needsCognition

Outcome Measures

Primary Outcomes (1)

  • Mini-Cog™ test

    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

Study Arms (3)

Passive Music Therapy (P)

EXPERIMENTAL

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

Other: Passive Music Therapy (P)

Active Music Therapy (A)

EXPERIMENTAL

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.

Other: Active Music Therapy (A)

Standard Care Control Condition (C)

ACTIVE COMPARATOR

The control condition involved mundane activities such as chatting, resting, or reading magazines, with the MT, in the treatment room.

Other: Standard Care Control Condition (C)

Interventions

Music Therapy Intervention

Passive Music Therapy (P)

Music Therapy Intervention

Active Music Therapy (A)

Without any intervention

Standard Care Control Condition (C)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • NeuroRehabilitation Needs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOSCO Rehabilitation Centre

Malacca, Malacca, 75450, Malaysia

Location

MeSH Terms

Conditions

DementiaStrokeBrain Injuries, TraumaticMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: participant will receive one passive music therapy session consisting of relaxation to music, one active music therapy session consisting of instrument-playing, and one control condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

December 5, 2023

Study Start

May 1, 2018

Primary Completion

April 30, 2019

Study Completion

January 21, 2020

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations