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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02003755
Other study ID # 99-3614B
Secondary ID
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


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
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