UPnRIDE Power Standing Wheelchair for SCI

NCT ID: NCT04163796

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2023-12-30

Brief Summary

People with higher level of spinal cord injury have limitations to using exoskeletal-assisted walking devices due to restrictions of trunk stability, functional use of the upper extremities and hand grip. With increasing sedentary time in wheelchairs, people with SCI have a high risk for developing secondary complications. A powered wheelchair has recently been developed for use in persons with spinal cord injury that provides a solution for placing the user in an upright, standing position while maintaining the overground mobility features of the powered wheelchair; providing the ability to engage in society in either a standing or seated position. The purpose of this study is to verify user performances of the upright powered wheelchair and to identify obstacles that are difficult, or prevent use. Additionally, the option to have upright posture throughout the day may have the potential to improve some of the secondary medical conditions associated with the extreme sedentary lifestyle.

This study will determine change from baseline after 12 weeks of use for safety, tolerance, medical, physical and quality of life outcomes. The intervention will consist of 3.5 hours per session, 3 times per week for 12 weeks. During each session, participants will be asked to stand at least 5 minutes during every 15 minutes. To our knowledge, there is no existing empirical data on intermittent standing during the day in persons with higher levels of SCI who cannot otherwise stand and whether this approach will improve health related outcomes.

Conditions

Spinal Cord Injuries

Study Design

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

Study Groups

UPnRIDE Training

During each session, heart rate (HR), blood pressure (BP), total session time, time in standing posture, count of sit-to-stand positioning, total distance of overground movement, and rating of perceived exertion (Borg scale) for mobility skills will be monitored. At all study visits during the training period, participants will be asked to answer general health questions about the occurrence of any pressure ulcers or infections.

Group Type: EXPERIMENTAL

UPnRIDE power wheelchair

Intervention Type: DEVICE

The intervention will consist of approximately 3.5 hours per session, 3 times per week over 12 weeks. During each 3.5-hour session, subjects will be asked to stand at least 5 minutes during every 15 minutes or more as tolerated. One time each session, participants will be asked to perform the Activities of Daily Living course.

Interventions

UPnRIDE power wheelchair

The intervention will consist of approximately 3.5 hours per session, 3 times per week over 12 weeks. During each 3.5-hour session, subjects will be asked to stand at least 5 minutes during every 15 minutes or more as tolerated. One time each session, participants will be asked to perform the Activities of Daily Living course.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Power wheelchair user as a primary means of mobility;

2. 18-89 years old;

3. ≥1 year after SCI;

4. Height of 160 to 190 cm;

5. Weight of <100 kg; and

6. Able to sign informed consent.

Exclusion Criteria

1. Able to ambulate with or without an assistive device or physical assistance greater than 4 consecutive steps;

2. Any pressure ulcer at any body location that is deemed to be contraindicated for a power wheelchair or standing frame by the study physician;

3. Concurrent medical disease that would be exclusionary for standing (as per the clinical judgment of the study physician);

4. Severe spasticity (Ashworth 4) or uncontrolled clonus;

5. History of fragility fractures, long bone fractures in the past 1 years, heterotrophic ossification, or other bone conditions that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician;

6. Significant contractures that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician

7. Psychiatric or cognitive status that may interfere with the ability to follow instruction to use the device; and

8. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bronx Veterans Medical Research Foundation, Inc

OTHER

Sponsor Role: lead

Responsible Party

EunKyoung Hong

Postdoctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EunKyoung Hong, PhD

Role: PRINCIPAL_INVESTIGATOR

Bronx VMRF

Locations

Spinal Cord Damage Research Center

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

SPU-17-036

Identifier Type: -

Identifier Source: org_study_id