Spinal Cord InjuriesNCT04241003
Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs
A study testing SmartDrive Mx2+ in people with Spinal Cord Injuries, run by Permobil, Inc. at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SmartDrive Mx2+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jun 2019to 14 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- SmartDrive Mx2+
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartDrive Mx2+Device
Rear-mounted power assist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SmartDrive Mx2+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wheelchair usage per day (time)
Data captured by study specific smart watch to document usage of wheelchair
Measured: 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
Measured: 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.
Measured: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Secondary outcomes (4)
Pain in upper extremities, WUSPI
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.
Measured: 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
The International Spinal Cord Injury Pain Basic Data Set is a questionnaire addressing clinically relevant core questions concerning SCI-related pain.
Measured: 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
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.
Measured: 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
Paper diary for pain score on a Likert scale rated by the participant every evening.
Measured: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start11 Jun 2019
- Primary completion9 Nov 2020
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Permobil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claes Hultling, Prof., Principal investigator, Spinalis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241003
- Sponsor's protocol ID
- Per2018M01
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Butler Forslund E, Lofvenmark I. Effects of the SmartDrive on mobility, activity, and shoulder pain among manual wheelchair users with spinal cord injury - a prospective long-term cohort pilot study. Disabil Rehabil Assist Technol. 2024 Feb;19(2):397-406. doi: 10.1080/17483107.2022.2091670. Epub 2022 Jul 5.
PubMed 35793399
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs
- ClinicalTrials.gov ID
- NCT04241003
- Acronym / sponsor ID
- Per2018M01
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Permobil, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartDrive - baseline and intervention | Experimental | Device: SmartDrive Mx2+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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartDrive Mx2+Rear-mounted power assist | Device | SmartDrive - baseline and intervention |
Primary outcome
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
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
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.
4 secondary outcomes
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
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
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
Change in pain level of patient reported wheelchair use
Time frame: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 35793399Butler Forslund E, Lofvenmark I. Effects of the SmartDrive on mobility, activity, and shoulder pain among manual wheelchair users with spinal cord injury - a prospective long-term cohort pilot study. Disabil Rehabil Assist Technol. 2024 Feb;19(2):397-406. doi: 10.1080/17483107.2022.2091670. Epub 2022 Jul 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claes Hultling, Prof. principal investigator
Spinalis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartDrive Mx2+ in people with Spinal Cord Injuries, run by Permobil, Inc. at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wheelchair usage per day (time) (time frame: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.