Cerebral PalsyNCT01367327
Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
A study testing Loaded sit-to-stand exercise and Synchronized music in people with Cerebral Palsy and Paraparesis, Spastic, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Cerebral Palsy, Paraparesis, Spastic
- What is being tested?
- Loaded sit-to-stand exercise and Synchronized music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2011
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with SD, aged 5 to 13 year-old, and GMFCS level between I to III
- able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
- able to follow verbal instructions
Who cannot join
- have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
- have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
- hearing loss or using hearing aid
- have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Institute of Physical Therapy, National Taiwan University
Taipei, 100
About this study
The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.
- Conditions
- Cerebral Palsy, Paraparesis, Spastic
- Being tested
- Loaded sit-to-stand exercise, Synchronized music
- Keywords
- Exercise
- Medical subject headings
- Cerebral Palsy, Paraparesis, Spastic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded sit-to-stand exerciseBehavioural
Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks
Synchronized musicBehavioural
Synchronized music for loaded sit-to-stand exercise to guide movement
| Study group | Role | What they receive |
|---|---|---|
| Exercise with music | Experimental | Loaded sit-to-stand exercise with music for 6 weeks Receives: Behavioral: Loaded sit-to-stand exercise; Behavioral: Synchronized music |
| Exercise without music | Active comparator | Loaded sit-to-stand exercise without music for 6 weeks Receives: Behavioral: Loaded sit-to-stand exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
Measured: 12 weeks
Secondary outcomes (5)
Intrinsic Motivation Inventory-Chinese Version
Measured: 12 weeks
Exercise Adherence and Volume
Measured: 12 weeks
Motor Control Variables of the STS Movement
Measured: 12 weeks
Pediatric Evaluation of Disability Inventory
Measured: 12 weeks
One-repetition maximum of loaded sit-to-stand test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hua-Fang Liao, MS, Study chair, Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367327
- Sponsor's protocol ID
- 0971762466
- Other IDs
- 98-2314-B-002-011-MY3
- Status last verified
- Feb 2012
- First submitted
- 9 Aug 2010
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.
PubMed 17207671Peng YC, Lu TW, Wang TH, Chen YL, Liao HF, Lin KH, Tang PF. Immediate effects of therapeutic music on loaded sit-to-stand movement in children with spastic diplegia. Gait Posture. 2011 Feb;33(2):274-8. doi: 10.1016/j.gaitpost.2010.11.020. Epub 2010 Dec 24.
PubMed 21185725
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT01367327
- Acronym / sponsor ID
- 0971762466
- Conditions
- Cerebral Palsy, Paraparesis, Spastic
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jun 2011 (estimated)
- 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.
The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with music | Experimental | Behavioral: Loaded sit-to-stand exercise, Behavioral: Synchronized musicLoaded sit-to-stand exercise with music for 6 weeks |
| Exercise without music | Active comparator | Behavioral: Loaded sit-to-stand exerciseLoaded sit-to-stand exercise without music for 6 weeks |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with SD, aged 5 to 13 year-old, and GMFCS level between I to III
- able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
- able to follow verbal instructions
Key exclusion criteria (4 listed)
- have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
- have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
- hearing loss or using hearing aid
- have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders
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 |
|---|---|---|
| Loaded sit-to-stand exerciseLoaded sit-to-stand exercise at home, 3 times a week for 6 weeks | Behavioural | Exercise with music, Exercise without music |
| Synchronized musicSynchronized music for loaded sit-to-stand exercise to guide movement | Behavioural | Exercise with music |
Primary outcome
Gross Motor Function Measure
Time frame: 12 weeks
5 secondary outcomes
Intrinsic Motivation Inventory-Chinese Version
Time frame: 12 weeks
Exercise Adherence and Volume
Time frame: 12 weeks
Motor Control Variables of the STS Movement
Time frame: 12 weeks
Pediatric Evaluation of Disability Inventory
Time frame: 12 weeks
One-repetition maximum of loaded sit-to-stand test
Time frame: 12 weeks
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 17 May 2012.
- Background: PubMed 17207671Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.
- Background: PubMed 21185725Peng YC, Lu TW, Wang TH, Chen YL, Liao HF, Lin KH, Tang PF. Immediate effects of therapeutic music on loaded sit-to-stand movement in children with spastic diplegia. Gait Posture. 2011 Feb;33(2):274-8. doi: 10.1016/j.gaitpost.2010.11.020. Epub 2010 Dec 24.
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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.
Hua-Fang Liao, MS study chair
Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loaded sit-to-stand exercise and Synchronized music in people with Cerebral Palsy and Paraparesis, Spastic, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 17 May 2012. 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 Taiwan. 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?
Gross Motor Function Measure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367327, which also lists 2 linked publications.
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 17 May 2012.