Muscle; Atrophy, GeneralHEPNCT03086187
The Effects of the Novel Unloading Device "HEPHAISTOS" on Bone, Muscles and Vessels
A study testing Hephaistos unloading orthosis in people with Muscle; Atrophy, General, run by DLR German Aerospace Center at 1 site in Germany.
Trial summary
11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention study. It greatly reduces calf muscle forces without reducing ground reaction forces. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle; Atrophy, General
- What is being tested?
- Hephaistos unloading orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- age: 20-45
- BMI: 20-30
Who cannot join
- smoking
- professional sports men
- diabetes
- rheumatism
- muscle and joint disease
- bone fractures within 12 months prior to the study
Show all 25Show fewer
- cruciate ligament rupture within 10 years prior to the study
- metal implants
- participation in any other clinical study within 2 months prior to the study haemophilia
- any blood vessel disease
- epilepsy
- claustrophobia
- herniated disk
- cardiac pulse generator
- drug or alcohol abuse
- hyperlipidaemia
- kidney disease
- hyperhomocysteaemia
- hyper/hypouricemia
- hyper/hypocalcaemia
- anaemia
- vitamin d deficit
- chronical back pain
- deficient certificate of good conduct
- achilles tendon injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels
11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention study.
It greatly reduces calf muscle forces without reducing ground reaction forces.
Read the 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.
- Conditions
- Muscle; Atrophy, General
- Being tested
- Hephaistos unloading orthosis
- Keywords
- weight bearing, muscle unloading, bone loss, arterial adaptation, muscular adaptation
- Medical subject headings
- Atrophy, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hephaistos unloading orthosisDevice
The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.
| Study group | Role | What they receive |
|---|---|---|
| Hephaistos unloading orthosis | Other | Hephaistos unloading orthosis: Calf muscle unloading: The 11 male subjects had to wear a novel orthosis for 8 weeks, which greatly reduces plantarflexor forces during gait. Receives: Device: Hephaistos unloading orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density as measured with pQCT
Change from baseline to 14 days after immobilization phase
Measured: At baseline and up to 12 months after the immobilization phase
Secondary outcomes (4)
Structural and functional parameters of arterial adaptation
Change in intima \& media thickness.
Measured: At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
Change in arterial diameter
Measured: At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
Change in blood flow
Measured: At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
Change in flow-mediated dilation
Measured: At baseline and up to 12 months after the immobilization phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startMar 2011
- Primary completionAug 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle; Atrophy, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn Rittweger, Prof. Dr., Study director, German Aerospace Center (DLR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086187
- Sponsor's protocol ID
- HEP
- Acronym
- HEP
- Status last verified
- Mar 2017
- First submitted
- 31 Jul 2012
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels
- ClinicalTrials.gov ID
- NCT03086187
- Acronym / sponsor ID
- HEP / HEP
- Conditions
- Muscle; Atrophy, General
- Keywords
- weight bearing, muscle unloading, bone loss, arterial adaptation, muscular adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention study.
It greatly reduces calf muscle forces without reducing ground reaction forces.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hephaistos unloading orthosis | Other | Device: Hephaistos unloading orthosisHephaistos unloading orthosis: Calf muscle unloading: The 11 male subjects had to wear a novel orthosis for 8 weeks, which greatly reduces plantarflexor forces during gait. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- age: 20-45
- BMI: 20-30
Key exclusion criteria (25 listed)
- smoking
- professional sports men
- diabetes
- rheumatism
- muscle and joint disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hephaistos unloading orthosisThe Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity. | Device | Hephaistos unloading orthosis |
Primary outcome
Bone density as measured with pQCT
Time frame: At baseline and up to 12 months after the immobilization phase
Change from baseline to 14 days after immobilization phase
4 secondary outcomes
Structural and functional parameters of arterial adaptation
Time frame: At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
Time frame: At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
Time frame: At baseline and up to 12 months after the immobilization phase
Structural and functional parameters of arterial adaptation
Time frame: At baseline and up to 12 months after the immobilization phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Webpage of the German Aerospace Center (DLR)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle; Atrophy, General
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping
Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)
Enrolling by invitationPhase 3
Global Open-Label Extension Study of Del-desiran for the Treatment of DM1
Myotonic Dystrophy Type 1, DM1
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Recruiting
Postoperative Electrical Muscle Stimulation Two
Surgery, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörn Rittweger, Prof. Dr. study director
German Aerospace Center (DLR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hephaistos unloading orthosis in people with Muscle; Atrophy, General, run by DLR German Aerospace Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density as measured with pQCT (time frame: At baseline and up to 12 months after the immobilization phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.