The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy

Cerebral Palsy (CP) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003755
• Other study ID #: 99-3614B
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: December 3, 2013
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Cerebral palsy (CP) is a group of disorders of the development of movement and posture but often changing motor impairment syndromes. The spastic subtypes are the most common manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated range of motion could reduce muscle's activation effectively. The polyarticular movement training might increase joint range of motion and reduce the muscle activation. But the polyarticular movement training is difficulty for some individuals with CP. The single joint movement training may achieve the same effect as the polyarticular movement training. The purpose of this study was to investigate the effects of continuation passive range of motion (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Spastic CP

• Modified Ashworth scale of Soleus > 1

• Ankle range of motion > 10 degrees

Exclusion Criteria:

• Fracture on lower Lower extremities

• BOTOX on ankle < 5 mouths

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy (CP)

Intervention

Procedure:
• Ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle tone tests	Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).	Baseline, 1, and 4 months.	No
Primary	Ankle range of motion	Measure of changes in Ankle range of motion.	Baseline, 1, and 4 months.	No
Primary	Hoffman reflex (H-reflex)	Measure of changes in Hoffman reflex (H-reflex).	Baseline, 1, and 4 months.	No
Secondary	Leg girth		Baseline,1 ,and 4 mouths.	No