Impact of Assistive Forces on Activities of Daily Living

NCT ID: NCT03004144

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2025-05-31

Brief 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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

FLOAT-Support

Group Type: OTHER

FLOAT

Intervention Type: OTHER

Interventions

FLOAT

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2016-01093

Identifier Type: -

Identifier Source: org_study_id