Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs

NCT04241003 | Completed FDA Device

• 1 other identifier: Per2018M01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study of manual wheelchair users with spinal cord injury (SCI). The users will be their own controls. The primary purpose of the study is to evaluate the ability of the power assist device SmartDrive to increase the ability to be mobile.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• Change in wheelchair usage per day (time)

  Data captured by study specific smart watch to document usage of wheelchair

  Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)

• Change in wheelchair usage per day (distance)

  Data captured by study specific smart watch to document usage of wheelchair

  Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)

• Change in activity level of patient reported wheelchair use

  Paper diary for activity level (high, medium, low) rated by the participant every evening.

  Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)

Secondary Outcomes (4)

• Pain in upper extremities, WUSPI

  At visit 2 and 3 (start and end of intervention) and at 3 and 6 months Follow up for a period of up to one year

• Pain in upper extremities, ISCOS

  At visit 2 and 3 (start and end of intervention) and at 3 and 6 months Follow up for a period of up to one year

• Wheelchair Outcome Measure WhOM

  At visit 2 and 3 (start and end of intervention) and at 3 and 6 months Follow up for a period of up to one year

• Change in pain level of patient reported wheelchair use

  Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)

Study Arms (1)

SmartDrive - baseline and intervention

EXPERIMENTAL

One arm for all users. Baseline - two weeks data collection documenting usage of wheelchair prior to intervention. Introduction of SmartDrive, a time period to get used to the SmartDrive and then two weeks data collection documenting usage of wheelchair with the intervention.

Device: SmartDrive Mx2+

Interventions

SmartDrive Mx2+ DEVICE

Rear-mounted power assist

SmartDrive - baseline and intervention

Eligibility Criteria

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

You may qualify if:

• Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
• years of age inclusive, at the time of signing the informed consent.
• Motor level C6-L3 Spinal Cord Injury, American Spinal Injury Association Impairment Scale (AIS) A-C since at least six months
• Full time manual wheelchair users, able to propel their own wheelchairs independently
• Eligible reason for SmartDrive prescription (Self-reported shoulder pain, and/or decreased physical endurance for propulsion, limiting user from activity)

You may not qualify if:

• Cognitive impairment affecting the ability to operate the SmartDrive, as deemed by prescribing clinician
• Weigh more than 150 kilos due to the technical specification of the SmartDrive
• Currently participating in another clinical study anticipated to affect the outcome or ability to compete this study
• Planned change from daily routines during the following two months, such as holiday, move, change jobs
• For any other reason not suitable for participation in the study, as deemed by prescribing clinician
• Do not use a smart phone

Sponsors & Collaborators

• Permobil, Inc.: lead

Study Sites (1)

Stiftelsen Spinalis

Solna, 169 70, Sweden

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

• Claes Hultling, Prof.

  Spinalis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 27, 2020
• Study Start: June 11, 2019
• Primary Completion: November 9, 2020
• Study Completion: May 14, 2021
• Last Updated: February 23, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)