NCT01367340

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 17, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

August 9, 2010

Last Update Submit

May 16, 2012

Conditions

Cerebral PalsySpastic Diplegia

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure

    1.5 months

Secondary Outcomes (6)

  • One-repetition maximum of loaded sit-to-stand

    1.5 months

  • Gait speed

    Week 0, 6, 12, 18, 24, 36, 42, 48, 72

  • 1-minute walk test

    1.5 months

  • School Function Assessment

    3 months

  • Pediatric Evaluation of Disability Inventory

    1.5 months

  • +1 more secondary outcomes

Study Arms (2)

Exercise and physical activity

EXPERIMENTAL
Behavioral: Loaded sit-to-stand resistance exerciseBehavioral: Physical activity intervention

Exercise only

ACTIVE COMPARATOR
Behavioral: Loaded sit-to-stand resistance exercise

Interventions

Loaded sit-to-stand resistance exerciseBEHAVIORAL

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

Exercise and physical activityExercise only
Physical activity interventionBEHAVIORAL

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.

Exercise and physical activity

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 17207671BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hua-Fang Liao, MS

    Institute of Physical Therapy, National Taiwan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2010

First Posted

June 7, 2011

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

May 17, 2012

Record last verified: 2012-02

Locations

TW(1)