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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Muscle; Atrophy, General
- Sponsor
- DLR German Aerospace Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Bone density as measured with pQCT
- Status
- Completed
- Last Updated
- 9 years ago
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: 1. Primary objective: Assessment and evaluation of bone adaptation. 2. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations. 3. Third objective: Assessment and evaluation of functional and structural vascular adaptations. 4. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
Investigators
Eligibility Criteria
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
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)