Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia

Cerebral Palsy Clinical Trial

Official title:

Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia Before and After Loaded Sit-to-Stand Training

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00314301
• Other study ID #: 94023
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2006
• Last updated: April 14, 2006
• Start date: April 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2006
• Source: Far Eastern Memorial Hospital
• Contact: Yuh-Ting Lin, MSc
• Phone: 866-2-8966-7000
• Email: yuh_ting_lin[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects: This study will recruit twenty children who are aged between 5 and 12 years, with spastic diplegia, and without having major surgeries or botulinum toxin injection on lower extremities during the past 6 months prior to participate in this study.

Methods: The Vicon 250 motion analysis system, 3 AMTI force platforms and the EMG recording system will be used to collect data of sit-to-stand (STS) movements. Baseline, pre- and post-training evaluations will be carried out. The duration of the baseline and pre-training evaluations is 2 months. The training period will take about 6 weeks. Each evaluation will take two separate days to accomplish. On the first day, the STS1RM of individual children was determined. On the second day, kinematic and kinetic data of STS movements in natural and loaded (applying load of 50% STS1RM during STS movements) conditions were collected. Data of smoothness, maximal extension moment and around hip and knee joints, onset time of lower extremity muscles will then be calculated. Results of each evaluation will be used for further comparison.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• loaded sit-to-stand training

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinematic measures of lower extremity and the whole body
Primary	kinetic measures of lower extremity and the whole body
Primary	electromyographic measures of lower extremity and the whole body