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Completed

NCT Number: NCT04241003

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stiftelsen Spinalis

Solna, 169 70, Sweden

About this study

The hypothesis of the study is that the SmartDrive will enable the user to be more active, both in commuting longer distances with less strokes needed, and managing single difficulties stopping them from activity. The two assessments selected, distance travelled and the daily diary, should directly reflect the impact of the SmartDrive. In addition, the the International Spinal Cord Society (ISCoS) pain data set, Wheelchair User's Shoulder Pain Index (WUSPI) and Wheelchair Outcome Measure (WhOM) will be used. In WhOM, the participants will state some activities they perform in their wheelchair that are important to them, and how satisfied they are with their current level of performance of that activity. After the intervention period the satisfaction is reassessed. This will enable to capture the effect SmartDrive usage has on the participant's daily life (beyond distance commuted and pain level).

After enrollment, the participants will be followed for two weeks using their wheelchair without SmartDrive. After attaching the SmartDrive, they will have three weeks to get into a use of the device on a regular basis in their everyday life, and then follows two consecutive weeks of study intervention and data collection. To capture the long-term effect and allow for season variability, follow-up data will be collected at three and six months after start of study intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
  • 18 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)

Exclusion criteria

  • 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

Treatment and study plan

SmartDrive Mx2+

Device

Rear-mounted power assist

Primary outcomes

  1. Change in wheelchair usage per day (time)

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

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

  2. Change in wheelchair usage per day (distance)

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

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

  3. Change in activity level of patient reported wheelchair use

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

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

Secondary outcomes

  1. Pain in upper extremities, WUSPI

    Time frame: 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 user shoulder pain index (WUSPI). WUSPI is a simple and effective self-report questionnaire for quickly measuring the functional cost of shoulder pain in wheelchair users. The WUSPI targets activity limitation resulting from shoulder pain (4 subsections), including wheelchair transfers, wheelchair mobility, selfcare and general activities.

  2. Pain in upper extremities, ISCOS

    Time frame: 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

    The International Spinal Cord Injury Pain Basic Data Set is a questionnaire addressing clinically relevant core questions concerning SCI-related pain.

  3. Wheelchair Outcome Measure WhOM

    Time frame: 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

    The WhOM is a client-centred two-part measure of wheelchair and seating system intervention, documenting expectations of the new intervention (part 1) which is followed up in the second part.

  4. Change in pain level of patient reported wheelchair use

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

    Paper diary for pain score on a Likert scale rated by the participant every evening.

Sponsors and collaborators

Lead sponsor

Permobil, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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