NCT03086187CompletedNot Applicable
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
DLR German Aerospace Center1 site in 1 country11 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- DLR German Aerospace Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Bone density as measured with pQCT
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age: 20-45
- •BMI: 20-30
Exclusion Criteria
- •professional sports men
- •rheumatism
- •muscle and joint disease
- •bone fractures within 12 months prior to the study
- •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
- •claustrophobia
- •herniated disk
- •cardiac pulse generator
- •drug or alcohol abuse
- •hyperlipidaemia
- •kidney disease
- •hyperhomocysteaemia
- •hyper/hypouricemia
- •hyper/hypocalcaemia
- •vitamin d deficit
- •chronical back pain
- •deficient certificate of good conduct
- •achilles tendon injury
Arms & Interventions
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.
Intervention: Hephaistos unloading orthosis (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Structural and functional parameters of arterial adaptation(At baseline and up to 12 months after the immobilization phase)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and VasculatureBone ResorptionNCT01576081DLR German Aerospace Center11
Completed
Not Applicable
Effects of using an upper limb rehabilitation support system as voluntary practice on concentration and muscle activityhealthy adultJPRN-UMIN000048533Suzuka University of Medical Science14
Not yet recruiting
Phase 3
In our study, we will look at patients who had surgery to repair rotator cuff (shoulder) muscles. We will give them exercises that reduce the strain (unload) on these muscles to see its effect on pain, function, kinesiophobia (fear of movement), and the thickness of the muscles themselves.CTRI/2024/07/069829MGM Institute of Physiotherapy
Recruiting
Not Applicable
Effect of post-operative upper limb exercises on outcomes ofarteriovenous fistula in patients with chronic kidney diseaseCTRI/2020/07/026437Kasturba Medical College
Recruiting
Not Applicable
Analysis of the effects of upper limb rehabilitation program in patients after stroke injecting with botulinum toxispasticitystrokeACTRN12617000262303The University of Physical Education150