UPnRIDE Power Standing Wheelchair for SCI

NCT04163796 | Completed DMC FDA Device

• 1 other identifier: SPU-17-036
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Wheelchair mobility skills - RPE

  Participants will be requested to perform a rating of perceived exertion (RPE).

  Training Period - 36 Sessions up to 12 weeks

• Wheelchair mobility skills - FIM

  Participants will be requested to perform a rating Functional Independence Measurement (FIM) for each UPnRIDE activity.

  Training Period - 36 Sessions up to 12 weeks

• Activities Daily Living Course - RPE

  Participants will be requested to perform a rating of perceived exertion (RPE) during the Activities Daily Living Course (ADLC).

  Training Period - 36 Sessions up to 12 weeks

• Activities Daily Living Course - FIM

  Participants will be requested to perform a rating Functional Independence Measurement (FIM) during the Activities Daily Living Course (ADLC).

  Training Period - 36 Sessions up to 12 weeks

Secondary Outcomes (14)

• Postural orthostatic hypotension blood pressure tolerance test (OH BP)

  Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)

• Pulmonary function tests - Spirometry

  Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)

• Pulmonary function tests - Static Lung Volumes

  Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)

• Pulmonary function tests - Breathing Pattern

  Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)

• Inflammatory biomarkers

  Evaluations - Baseline/After session 18 (up to 6 weeks) /After session 36 (up to 12 weeks)

Study Arms (1)

UPnRIDE Training

EXPERIMENTAL

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.

Device: UPnRIDE power wheelchair

Interventions

UPnRIDE power wheelchair 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.

UPnRIDE Training

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Power wheelchair user as a primary means of mobility;
• years old;
• ≥1 year after SCI;
• Height of 160 to 190 cm;
• Weight of \<100 kg; and
• Able to sign informed consent.

You may not qualify if:

• Able to ambulate with or without an assistive device or physical assistance greater than 4 consecutive steps;
• Any pressure ulcer at any body location that is deemed to be contraindicated for a power wheelchair or standing frame by the study physician;
• Severe spasticity (Ashworth 4) or uncontrolled clonus;
• Psychiatric or cognitive status that may interfere with the ability to follow instruction to use the device; and
• Pregnant or lactating women.

Sponsors & Collaborators

• Bronx Veterans Medical Research Foundation, Inc: lead

Study Sites (1)

Spinal Cord Damage Research Center

The Bronx, New York, 10468, United States

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 Officials

• EunKyoung Hong, PhD

  Bronx VMRF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: November 15, 2019
• Study Start: August 1, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

US (1)