NCT01367327

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2009

Completed
1.6 years 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 17, 2012

Status Verified

February 1, 2012

Enrollment Period

2.9 years

First QC Date

August 9, 2010

Last Update Submit

May 16, 2012

Conditions

Cerebral PalsyParaparesis, Spastic

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure

    12 weeks

Secondary Outcomes (5)

  • Intrinsic Motivation Inventory-Chinese Version

    12 weeks

  • Exercise Adherence and Volume

    12 weeks

  • Motor Control Variables of the STS Movement

    12 weeks

  • Pediatric Evaluation of Disability Inventory

    12 weeks

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

    12 weeks

Study Arms (2)

Exercise with music

EXPERIMENTAL

Loaded sit-to-stand exercise with music for 6 weeks

Behavioral: Loaded sit-to-stand exerciseBehavioral: Synchronized music

Exercise without music

ACTIVE COMPARATOR

Loaded sit-to-stand exercise without music for 6 weeks

Behavioral: Loaded sit-to-stand exercise

Interventions

Loaded sit-to-stand exerciseBEHAVIORAL

Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks

Exercise with musicExercise without music
Synchronized musicBEHAVIORAL

Synchronized music for loaded sit-to-stand exercise to guide movement

Exercise with music

Eligibility Criteria

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

You may qualify if:

  • 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

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
  • have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders

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 (2)

  • 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

  • Peng 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.

    PMID: 21185725BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyParaparesis, SpasticMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParaparesisParesisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

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

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 17, 2012

Record last verified: 2012-02

Locations

TW(1)