The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
Primary Purpose
Cerebral Palsy (CP)
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ankle continuous passive motion machine.
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy (CP) focused on measuring Cerebral palsy, Continuous passive motion, Hypertonia
Eligibility Criteria
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
Sites / Locations
- Chang Gung University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spastic CP
Arm Description
continuous passive motion training
Outcomes
Primary Outcome Measures
Muscle tone tests
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).
Ankle range of motion
Measure of changes in Ankle range of motion.
Hoffman reflex (H-reflex)
Measure of changes in Hoffman reflex (H-reflex).
Secondary Outcome Measures
Leg girth
Full Information
NCT ID
NCT02003755
First Posted
December 3, 2013
Last Updated
December 3, 2013
Sponsor
Chang Gung University
1. Study Identification
Unique Protocol Identification Number
NCT02003755
Brief Title
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy (CP)
Keywords
Cerebral palsy, Continuous passive motion, Hypertonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spastic CP
Arm Type
Experimental
Arm Description
continuous passive motion training
Intervention Type
Procedure
Intervention Name(s)
Ankle continuous passive motion machine.
Intervention Description
A rehabilitation program of machine driven passive stretch.
Primary Outcome Measure Information:
Title
Muscle tone tests
Description
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).
Time Frame
Baseline, 1, and 4 months.
Title
Ankle range of motion
Description
Measure of changes in Ankle range of motion.
Time Frame
Baseline, 1, and 4 months.
Title
Hoffman reflex (H-reflex)
Description
Measure of changes in Hoffman reflex (H-reflex).
Time Frame
Baseline, 1, and 4 months.
Secondary Outcome Measure Information:
Title
Leg girth
Time Frame
Baseline,1 ,and 4 mouths.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
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