The Novel Unloading Device "HEPHAISTOS" and Its Effects U... | NCT01576081

Studies
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature

NCT01576081

Sponsor

DLR German Aerospace Center

Status

Completed

Last Update Posted

Aug 16, 2012Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Bone Resorption

Interventions

HEPHAISTOS

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Apr 3, 2012

First Submission Date that Met QC Criteria

Apr 11, 2012

First Posted Date

Apr 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2012

Last Update Posted Date

Aug 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.

Detailed Description

The 56day unloading intervention with HEPHAISTOS had the following key objectives:

Primary objective: Assessment and evaluation of bone adaptation.
Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
Third objective: Assessment and evaluation of functional and structural vascular adaptations.
Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unilateral orthotic intervention	Experimental	The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.	Device: HEPHAISTOS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HEPHAISTOS	Device	HEPHAISTOS unloading orthotic	Unilateral orthotic intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone density as measured with pQCT	subjects will be followed for one year, starting from the onset of the study	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male
age: 20-40 years
BMI: 20-30
passing the psychological and medical check up.
signed consent to participate in the study
faultless certificate of good conduct

Exclusion Criteria:

smoking
professional athletes
diabetes
muscle or joint disease
trabecular bone density in the distal tibia epiphysis < 160mg/cm3
increase risk of thrombosis
bone fractures 12 months prior to the study
metal implants, any material of osteosynthesis
participation in another clinical intervention study 2 months prior to the study
bleeding disorder
anesthetic intolerance
vascular disease
epilepsy
claustrophobia
herniated disk
pacemaker
alcohol or drug abuse
anti-inflammatory drug intake during the study
hyperlipidemia
kidney disease
hyperhomocysteinaemia
vitamin d deficit
chronical back pain
detained

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joern Rittweger, Prof. Dr.	DLR German Aerospace Center	Study Director
Tobias Weber	DLR German Aerospace Center	Principal Investigator
Michel Ducos	DLR German Aerospace Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
German Aerospace Center		Cologne		51147	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24119174	Derived	Weber T, Ducos M, Mulder E, Beijer A, Herrera F, Zange J, Degens H, Bloch W, Rittweger J. The relationship between exercise-induced muscle fatigue, arterial blood flow and muscle perfusion after 56 days local muscle unloading. Clin Physiol Funct Imaging. 2014 May;34(3):218-29. doi: 10.1111/cpf.12087. Epub 2013 Oct 7.
23221961	Derived

ID	Term
D001862	Bone Resorption
D009133	Muscular Atrophy

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations