Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03355755|
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Debility Due to Disease||Device: EksoGT with SmartAssist software||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm safety and feasibility study.|
|Masking:||None (Open Label)|
|Official Title:||Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury|
|Actual Study Start Date :||October 11, 2017|
|Actual Primary Completion Date :||December 13, 2018|
|Actual Study Completion Date :||December 13, 2018|
Experimental: Interventional Group
All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.
Device: EksoGT with SmartAssist software
Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
- Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events [ Time Frame: 2 weeks ]The primary endpoint is safety defined as the number of device-related serious adverse events per Participant and overall during the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355755
|United States, Connecticut|
|Gaylord Specialty Healthcare|
|Wallingford, Connecticut, United States, 06492|
|United States, Illinois|
|Marianjoy Rehabilitation Hospital|
|Wheaton, Illinois, United States, 60187|
|United States, Nebraska|
|Quality Living, Inc|
|Omaha, Nebraska, United States, 68104|