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Trial registered on ANZCTR


Registration number
ACTRN12612000926831
Ethics application status
Not yet submitted
Date submitted
24/08/2012
Date registered
30/08/2012
Date last updated
30/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Therapeutic Instrumental Music in improving the upper limb function and mood of stroke patients in a rehabilitation setting
Scientific title
The effects of rhythmic stimulation to improve upper limb function and mood of stroke patients in inpatient rehabilitation setting
Secondary ID [1] 281090 0
None
Universal Trial Number (UTN)
Trial acronym
TIMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke Patients 287243 0
Condition category
Condition code
Stroke 287568 287568 0 0
Haemorrhagic
Stroke 287570 287570 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design is a randomized controlled trial of 26 patients receiving standard rehabilitation together with Music Therapy intervention who will be compared with 26 patients receiving only standard rehabilitation as usual. Each standard occupational therapy session will last for up to 60 minutes, out of which up to 30 minutes will be focused on upper limb rehabilitation. The music therapy intervention will have up to 30 minutes therapy session and is provided daily by a board certified music therapist for a duration of 10 sessions (exclude weekends and public holidays). The components of the intervention include music rhythmic stimulation with movement exercises directed by occupational therapis simultaneously. The exercise is
sequential flexion-extension of elbow movements of one arm.

All subjects in the study will received individualised therapy. All subjects in either condition will receive up to 60-minute intervention daily for a duration of 10 sessions (exclude weekends and public holidays). The follow-up will be 3 weeks.
Intervention code [1] 285542 0
Rehabilitation
Intervention code [2] 285562 0
Treatment: Other
Comparator / control treatment
For control group: All subjects in the control group will receive up to 60-minute of standard OT session, out of which up to 30 minutes will comprise of upper limb exercise which is individually designed based on individual impairment and needs. Subjects receive individualized therapy in SGH Inpatient Rehabilitation Wards.
Control group
Active

Outcomes
Primary outcome [1] 287821 0
Action Research Arm Test (ARAT). The ARAT is used to determine upper limb function . It is an observational test that is designed to assess recovery in the upper limb following cortical damage. The test consists of 19 items with each item rated on a 4-point scale with "0" indicating no movement possible and "3" indicating movement performed normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, higher scores will indicate better performance
Timepoint [1] 287821 0
Measurements taken at commencement and end of study
Primary outcome [2] 287856 0
Fugyl Meyer Assessment (FMA). It is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. FMA is comprised of five domains, including (1) Motor functioning (in the upper and lower extremities), (2) Sensory functioning, (3) Balance, (4) Joint range of motion and (5) Joint pain. It is applied clinically and in research to determine disease severity, describe motor recovery and to plan and assess treatment.
Timepoint [2] 287856 0
Measurements taken at commencement and end of study
Primary outcome [3] 287857 0
Jebson-Taylor Hand Function Test (JTHFT). It was designed to provide a short, objective test of hand functions commonly used in activities of daily living. The test items include a range of fine motor, weighted and non-weighted hand function activities which are timed: (1) writing (copying) a 24-letter sentence, (2) turning over 3 x 5? cards, (3) picking up small common objects such as a paper clip, bottle cap and coin (4) simulated feeding using a teaspoon and five kidney beans, (5) stacking checkers, (6) picking up large light objects (empty tin can) and (7) picking up large heavy objects (full tin can x 1 lb). There is a choice of 4 pre-written sentences for the writing subtest so that a different sentence can be selected for each re-test with the same patient.
Timepoint [3] 287857 0
Measurements taken at commencement and end of study
Secondary outcome [1] 298892 0
Pittsburgh Rehabilitation Participation Scale (PRPS). The PRPS is a clinician-rated 6-point Likert-type item measuring patient participation in inpatient rehabilitation sessions. Patients will be rated based on observations by therapist and study investigators on a scale of 1 (none) to 6 (excellent).
Timepoint [1] 298892 0
Measurements taken at commencement and end of study
Secondary outcome [2] 298945 0
Motor Activity Log (MAL). It is a 30-item structured interview intended to examine how much and how well the patients use their more-affected arm outside of the laboratory setting. Patients are asked standardized questions about the amount of use of their more-affected arm (Amount Scale: 0 representing 'not used' to 5 representing 'same as pre-stroke') and the quality of their movement (How Well Scale: 0 representing 'not used' to 5 representing 'normal') during the functional activities indicated.
Timepoint [2] 298945 0
Measurements taken at commencement and end of study
Secondary outcome [3] 298946 0
Time taken for completion of specified task will be recorded by using a stopwatch and time will be recorded in seconds. The timed task will involve coordination of multiple upper limb joint movements for task performance. In the specified task, participant will reach out to pick up a block and place on the designated location, this will be repeated 8 times. Shorter time taken, will indicate better upper limb coordination.
Timepoint [3] 298946 0
Measurements taken at commencement and end of study
Secondary outcome [4] 298947 0
Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item scale, with seven items measuring anxiety (HADS-A) and seven measuring depression (HADS-D). Each item is on a 4-point ordinal scale with "0" indicating least frequency occurrence versus "3" which indicates highest frequency of occurrence. The scores range from 0-21 for each scale with higher scores indicating more distress.
Timepoint [4] 298947 0
Measurements taken at commencement and end of study
Secondary outcome [5] 298948 0
Visual analog mood scale (The Faces Scale, Andrews & Withey, 1976). The Faces scale consists of seven faces that progress from a smilling face to a frowning face, and participants will circle the face that closest to expressing how they feel.
Timepoint [5] 298948 0
Measurements taken at commencement and end of study

Eligibility
Key inclusion criteria
Inclusion criteria:
Patients diagnosed with stroke, who is at least 21 years of age or above and admitted to SGH Department of Rehabilitation Medicine between the period of November 2012 - October 2013.
- Acquired brain injury, that is, stroke
- First stroke patient referred for occupational therapy
- MMSE greater or equal to 18 (Levels of impairment have also been classified as none (24-30); mild (18-23) and severe (0-17) (Tombaugh & McIntyre 1992)
- Upper limb impairment Manual Muscle Testing (MMT) = 1, 2 or 3
- Medically stable to participate in an active rehabilitation program
Minimum age
21 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
* Individuals will be excluded if they have any other acute co-morbidities influencing their mobility, that is:
- Patients with pre-existing upper limb impairments eg. Amputation, deformity, contracture
- Patients with Parkinson's Disease
- Patients with severe spasticity (MAS greater than or equal to 2)
- Patients with severe hearing impairment
* Patients recruited in other study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients from Singapore General Hospital (SGH) Inpatient Rehabilitation Wards will be asked to participate in the study. Consenting patients will be randomized into two groups (intervention vs. conventional treatment) using sealed opaque envelops by an independent staff not involved in the study, the allied health research coordinator. Random number will be generated by third party who is not involved in the study. All subjects in either condition will receive up to 60-minute daily intervention for a duration of 10 sessions (excluding weekends and public holidays)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Immediately after getting informed consent, the patients will be randomized into two groups either to the music therapy plus standard rehabilitation or to the standard rehabilitation alone by using computer generated random sequence numbers with the sealed opaque envelops by a third person who will not be involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 4508 0
Singapore
State/province [1] 4508 0

Funding & Sponsors
Funding source category [1] 285874 0
Hospital
Name [1] 285874 0
Singhealth Foundation Grant
Country [1] 285874 0
Singapore
Primary sponsor type
Individual
Name
Patsy Tan Lee Peng
Address
Allied Health Division
Bowyer Block B Level 2
Singapore General Hospital
Outram Road, Singapore 169608
Country
Singapore
Secondary sponsor category [1] 284699 0
Hospital
Name [1] 284699 0
Singapore General Hospital
Address [1] 284699 0
Singapore General Hospital
Outram Road, Singapore 169608
Country [1] 284699 0
Singapore

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287902 0
SingHealth Centralised Institute Review Board
Ethics committee address [1] 287902 0
Ethics committee country [1] 287902 0
Singapore
Date submitted for ethics approval [1] 287902 0
10/07/2012
Approval date [1] 287902 0
Ethics approval number [1] 287902 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34616 0
Address 34616 0
Country 34616 0
Phone 34616 0
Fax 34616 0
Email 34616 0
Contact person for public queries
Name 17863 0
Chua Ching Ching
Address 17863 0
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3, #06-08
Singapore 150168
Country 17863 0
Singapore
Phone 17863 0
+(65) 6326 6802
Fax 17863 0
Email 17863 0
[email protected]
Contact person for scientific queries
Name 8791 0
Patsy Tan Lee Peng
Address 8791 0
Allied Health Division
Bowyer Block B Level 2
Singapore General Hospital
Outram Road, Singapore 169608
Country 8791 0
Singapore
Phone 8791 0
+(65) 8223-1736
Fax 8791 0
Email 8791 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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