Impact of Assistive Forces on Activities of Daily Living

Spinal Cord Injury Clinical Trial

— FLOAT-ADL  

Official title:

Impact of Robotic Assistive Forces on the Performance of Activities of Daily Living

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03004144
• Other study ID #: 2016-01093
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 31, 2025

Study information

• Verified date: September 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a cross-sectional study investigating the impact of assistive forces applied by the body-weight support system "the FLOAT" on the study participants. The study is conducted at the University Hospital Balgrist in Zurich over a period of around 3 years. During this time measurements on approximately 140 able bodied subjects and 60 patients with an incomplete spinal cord injury will take place. The study participants are invited for a single visit of around 140 min duration to the University Hospital Balgrist. During this visit the study participants will repeatedly perform various activities of daily living (free walking, standing up and sitting down, stair climbing and balancing) with and without assistive forces from the body-weight support system. While performing the tasks, the study participants' motions and muscle activities will be measured to evaluate the naturalness of their movements. In addition, the collected data permits us to compare different movement patterns and make conclusions about effective and optimal movement support. Obtaining this knowledge will help us to shape the therapy of these activities to be tailored to the patients and to train these movements with the help of the FLOAT under optimal conditions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons
• informed consent as documented by signature
• bodyweight < 120 kg

Exclusion Criteria:

• a significant psychiatric or orthopedic diagnose
• any secondary neurological complications that may impact the outcome variables
• dermatological conditions (pressure ulcers, etc.)
• pacemaker or other implanted, electronic devices
• contraindications for FLOAT training
• inability or unwillingness to provide written informed consent or follow study procedures e.g. due to language problems
• psychological disorders, dementia, etc.
• known or suspected non-compliance, drug or alcohol abuse
• enrolment of the investigator, his/her family members, employees and other dependent persons

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• FLOAT

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks		Once (single visit) around 140 minutes duration