Impact of Assistive Forces on Activities of Daily Living

NCT03004144 | Completed

• 1 other identifier: 2016-01093
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks

  Once (single visit) around 140 minutes duration

Study Arms (1)

FLOAT-Support

OTHER

Other: FLOAT

Interventions

FLOAT OTHER

FLOAT-Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: December 28, 2016
• Study Start: October 1, 2016
• Primary Completion: October 24, 2019
• Study Completion: May 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)