CClinicalTrials.gg
Status unknownNCT01367340Updated May 17, 2012

Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training

An interventional study of Loaded sit-to-stand resistance exercise and Physical activity intervention in Cerebral Palsy and Spastic Diplegia, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2012-05-17.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
5 Years to 13 Years
Sex
All
01

Study 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. The primary outcomes are gross motor function, participation, and physical activity behavior.

02

Conditions studied

  • Cerebral Palsy
  • Spastic Diplegia
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In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 32 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Exercise and physical activity

    Behavioral: Loaded sit-to-stand resistance exercise · Behavioral: Physical activity intervention

  • Active comparator
    Exercise only

    Behavioral: Loaded sit-to-stand resistance exercise

Interventions

  • BehavioralLoaded sit-to-stand resistance exercise

    Loaded STS exercise at home, 3 times a week for 6 weeks

  • BehavioralPhysical activity intervention

    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.

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What researchers measure

Primary outcomes

  1. Gross Motor Function Measure

    Time frame: 1.5 months

Secondary outcomes

  1. One-repetition maximum of loaded sit-to-stand

    Time frame: 1.5 months

  2. Gait speed

    Time frame: Week 0, 6, 12, 18, 24, 36, 42, 48, 72

  3. 1-minute walk test

    Time frame: 1.5 months

  4. School Function Assessment

    Time frame: 3 months

  5. Pediatric Evaluation of Disability Inventory

    Time frame: 1.5 months

  6. Physical activity status by International Physical Activity Questionnaire and accelerometer

    Time frame: 3 months

07

Study locations

1 site
  • Institute of Physical Therapy, National Taiwan University
    Taipei, 100, Taiwan
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01367340
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 7, 2011
Start date
Aug 2010
Primary completion
Dec 2012 (estimated)
Completion
Dec 2013 (estimated)
Last update
May 17, 2012

Study contacts

Hua-Fang Liao, MS
study chair · Institute of Physical Therapy, National Taiwan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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