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Endermotherapy, Passive manual stretching

Phase 2

Cerebral Palsy | Unknown | Neurology |Co-Diagnostics, Inc.|Last Updated: Oct 10, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01207570Endermotherapy for Children With Developmental DisabilitiesPHASE2 COMPLETED 54Feb 1, 2010May 1, 2011Oct 10, 20111 Hong Kong
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Study Endpoints
Primary Endpoints
Ankle Passive Range of Motion
day 1 before treatment

The ankle passive range of motion will be measured by a Myrin goniometer.

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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EndermotherapyEXPERIMENTALThe subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
Passive stretchingACTIVE_COMPARATORThe subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
Interventions
NameTypeDescription
EndermotherapyPROCEDUREThe subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist.
Passive manual stretchingPROCEDUREThe subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist.
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Eligibility Criteria
Age Range2 Years — 6 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * children aged between 2 and 6. * children with diagnosis of cerebral palsy or developmental disabilities. * Has limited ankle dorsiflexion range of motion (less than 20 degrees) Exclusion Criteria: * Other serious illnesses that preclude participation

Countries:Hong Kong
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