Cerebral PalsyNCT01367340
Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training
A study testing Loaded sit-to-stand resistance exercise and Physical activity intervention in people with Cerebral Palsy and Spastic Diplegia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia
- What is being tested?
- Loaded sit-to-stand resistance exercise and Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Dec 2013
- 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 spastic diplegia, aged 6 to 12 year-old, and Gross Motor Function Classification System (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 answer questionnaire designed for school-age children
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Institute of Physical Therapy, National Taiwan University
Taipei, 100
About this study
Official title: Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
The purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. The primary outcomes are gross motor function, participation, and physical activity behavior.
- Conditions
- Cerebral Palsy, Spastic Diplegia
- Being tested
- Loaded sit-to-stand resistance exercise, Physical activity intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded sit-to-stand resistance exerciseBehavioural
Loaded STS exercise at home, 3 times a week for 6 weeks
Physical activity interventionBehavioural
The intervention is based on the social cognitive theory and the transtheoretical model. There are two principle components, the individual consultation and the small group PA activities. In the individual consultation, assessment of current stage of readiness for PA will be performed first. Then, individualized, stage-matched feedback will be sent to the participants. Small group PA activities will be held every 2 weeks in order to increase learning opportunity by peer interaction, make exercise fun, and introduce a role model.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and physical activity | Experimental | Not described Receives: Behavioral: Loaded sit-to-stand resistance exercise; Behavioral: Physical activity intervention |
| Exercise only | Active comparator | Not described Receives: Behavioral: Loaded sit-to-stand resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
Measured: 1.5 months
Secondary outcomes (6)
One-repetition maximum of loaded sit-to-stand
Measured: 1.5 months
Gait speed
Measured: Week 0, 6, 12, 18, 24, 36, 42, 48, 72
1-minute walk test
Measured: 1.5 months
School Function Assessment
Measured: 3 months
Pediatric Evaluation of Disability Inventory
Measured: 1.5 months
Physical activity status by International Physical Activity Questionnaire and accelerometer
Measured: 3 months
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 startAug 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 32 participants (estimated)
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
- NCT01367340
- Sponsor's protocol ID
- 0993702914
- 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 17207671
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
- Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
- ClinicalTrials.gov ID
- NCT01367340
- Acronym / sponsor ID
- 0993702914
- Conditions
- Cerebral Palsy, Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- 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 this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. The primary outcomes are gross motor function, participation, and physical activity behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and physical activity | Experimental | Behavioral: Loaded sit-to-stand resistance exercise, Behavioral: Physical activity intervention |
| Exercise only | Active comparator | Behavioral: Loaded sit-to-stand resistance exercise |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children with spastic diplegia, aged 6 to 12 year-old, and Gross Motor Function Classification System (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 answer questionnaire designed for school-age children
- able to follow verbal instructions
Key exclusion criteria (3 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
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 resistance exerciseLoaded STS exercise at home, 3 times a week for 6 weeks | Behavioural | Exercise and physical activity, Exercise only |
| Physical activity interventionThe intervention is based on the social cognitive theory and the transtheoretical model. There are two principle components, the individual consultation and the small group PA activities. In the individual consultation, assessment of current stage of readiness for PA will be performed first. Then, individualized, stage-matched feedback will be sent to the participants. Small group PA activities will be held every 2 weeks in order to increase learning opportunity by peer interaction, make exercise fun, and introduce a role model. | Behavioural | Exercise and physical activity |
Primary outcome
Gross Motor Function Measure
Time frame: 1.5 months
6 secondary outcomes
One-repetition maximum of loaded sit-to-stand
Time frame: 1.5 months
Gait speed
Time frame: Week 0, 6, 12, 18, 24, 36, 42, 48, 72
1-minute walk test
Time frame: 1.5 months
School Function Assessment
Time frame: 3 months
Pediatric Evaluation of Disability Inventory
Time frame: 1.5 months
Physical activity status by International Physical Activity Questionnaire and accelerometer
Time frame: 3 months
Results and safety
Results are not available in the source record.
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.
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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 resistance exercise and Physical activity intervention in people with Cerebral Palsy and Spastic Diplegia, 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 4 inclusion and 3 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: status not confirmed, 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?
Results are not available in the source record.
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: 1.5 months). 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 NCT01367340, which also lists 1 linked publication.
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.