NCT00314301

Brief Summary

The purpose of this study is to compare movement variations before and after the loaded training, with kinematics, kinetics, and electromyography, in children with spastic diplegia and to further discuss mechanisms of the loaded training.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 17, 2006

Status Verified

April 1, 2006

First QC Date

April 12, 2006

Last Update Submit

April 14, 2006

Conditions

Cerebral Palsy

Keywords

cerebral palsyresistancemovementbiomechanics

Outcome Measures

Primary Outcomes (3)

  • kinematic measures of lower extremity and the whole body

  • kinetic measures of lower extremity and the whole body

  • electromyographic measures of lower extremity and the whole body

Interventions

loaded sit-to-stand trainingDEVICE

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed as spastic diplegia
  • Aged between 5 and 12 years
  • Able to perform the STS movements without assistance
  • Able to cooperate and understand commands given

You may not qualify if:

  • Severe musculoskeletal deformity or pain on lower extremities
  • Botulism injection in the past 3 months or major operations in the preceding 6 months on lower extremities
  • Uncontrolled epilepsy
  • Major sensory deficits, such as blindness or deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yuh-Ting Lin, MSc

    Research Ethics Review Committee of the Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuh-Ting Lin, MSc

CONTACT

866-2-8966-7000yuh_ting_lin@hotmail.com

Jao-Shwann Liang, MD

CONTACT

866-2-8966-7000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 13, 2006

Study Start

April 1, 2006

Study Completion

September 1, 2007

Last Updated

April 17, 2006

Record last verified: 2006-04

Locations

TW(1)