DementiaNCT06156735
Music Therapy on Cognition in Neurorehabilitation
A study testing Passive Music Therapy (P) and Active Music Therapy (A) in people with Dementia and Stroke, run by University of Malaya at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Dementia, Stroke, Traumatic Brain Injury
- What is being tested?
- Passive Music Therapy (P) and Active Music Therapy (A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2018to 21 Jan 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- NeuroRehabilitation Needs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Therapy on Cognition in Neurorehabilitation - A Feasibility Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Dementia, Stroke, Traumatic Brain Injury
- Being tested
- Passive Music Therapy (P), Active Music Therapy (A), Standard Care Control Condition (C)
- Keywords
- Music therapy, Active, Passive, neurorehabilitation needs, Cognition
- Medical subject headings
- Dementia, Stroke, Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Music Therapy (P)Other
Music Therapy Intervention
Active Music Therapy (A)Other
Music Therapy Intervention
Standard Care Control Condition (C)Other
Without any intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: Standard Care Control Condition (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 May 2018
- Primary completion30 Apr 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156735
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Cognition in Neurorehabilitation - A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06156735
- Conditions
- Dementia, Stroke, Traumatic Brain Injury
- Keywords
- Music therapy, Active, Passive, neurorehabilitation needs, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 5 Dec 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Passive Music Therapy (P) | Experimental | Other: 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 |
| Active Music Therapy (A) | Experimental | Other: 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. |
| Standard Care Control Condition (C) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- NeuroRehabilitation Needs
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Passive Music Therapy (P)Music Therapy Intervention | Other | Passive Music Therapy (P) |
| Active Music Therapy (A)Music Therapy Intervention | Other | Active Music Therapy (A) |
| Standard Care Control Condition (C)Without any intervention | Other | Standard Care Control Condition (C) |
Primary outcome
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.
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Music Therapy (P) and Active Music Therapy (A) in people with Dementia and Stroke, run by University of Malaya at 1 site in Malaysia.
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 1 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 10 Apr 2025. 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 Malaysia. 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?
Mini-Cog™ test (time frame: 1 year). 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 10 Apr 2025.