- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02003755
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
December 3, 2013 updated by: Ya-Ju Chang, Chang Gung University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taoyuan, Taiwan, 333
- Chang Gung University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spastic CP
continuous passive motion training
|
A rehabilitation program of machine driven passive stretch.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle tone tests
Time Frame: Baseline, 1, and 4 months.
|
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).
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Baseline, 1, and 4 months.
|
|
Ankle range of motion
Time Frame: Baseline, 1, and 4 months.
|
Measure of changes in Ankle range of motion.
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Baseline, 1, and 4 months.
|
|
Hoffman reflex (H-reflex)
Time Frame: Baseline, 1, and 4 months.
|
Measure of changes in Hoffman reflex (H-reflex).
|
Baseline, 1, and 4 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Leg girth
Time Frame: Baseline,1 ,and 4 mouths.
|
Baseline,1 ,and 4 mouths.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
December 3, 2013
First Submitted That Met QC Criteria
December 3, 2013
First Posted (Estimate)
December 6, 2013
Study Record Updates
Last Update Posted (Estimate)
December 6, 2013
Last Update Submitted That Met QC Criteria
December 3, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-3614B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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