Physical DisabilityNCT03469414
Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
An observational study of Physical Disability, run by Allina Health System at 1 site in United States.
Trial summary
This is a cross-section correlational study that will examine the relationships between wheelchair speed, maneuverability, and endurance with community integration. By identifying which of these has the biggest contribution to community participation, the information will be used to justify continues therapy, to alter… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Disability
- What is being tested?
- Life Space Assessment Scale, 6-Minute Push Test and Forward Push Test
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2018to 1 Feb 2021
- Phase
- Observational
- 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
Study population: 260 participants with disabilities who use manual wheelchairs for their primary mobility. Participants will be recruited from all Courage Kenny Rehabilitation Institute sites. Participants will have a mixture of diagnosis, with a minimum of 30 individuals with diagnosis of stroke and 30 individuals with diagnosis with spinal cord injury.
Who may be able to join
- 18 years or older
- presence of a physical disability
- use of a manual wheelchair for primary mobility
- living in the community.
Who cannot join
- individuals who have significant expressive or receptive language deficits (i.e. aphasia, verbal apraxia, etc.)
- limb orthopedic conditions that would contraindicate speed and endurance testing, such as recent fractures or joint instability
- cardiopulmonary resting heart rate of less than 50 or over 100, resting vitals of systolic blood pressure of > 200 or < 90, diastolic blood pressure of >110, resting O2 levels of less than 90 (ACSM, 205; Fletcher, et al., 1993).
- any other cardiac symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Courage Kenny Rehabilitation Institute
Golden Valley, Minnesota, 55422
About this study
This is a cross-section correlational study that will examine the relationships between wheelchair speed, maneuverability, and endurance with community integration. By identifying which of these has the biggest contribution to community participation, the information will be used to justify continues therapy, to alter the focus of therapy, and to justify purchase of power or power assist wheelchairs when needed. Currently, therapists make the recommendation for a power or power assist chair based on their clinical judgement and the patient's experience, but there has been limited justification from the literature for these decisions. Finally, because the CHART measure is the gold standard in rehabilitation research for community integration, but has psychometric problems, we will use this opportunity to validate a new more psychometrically solid measure, the PART-O, against the CHART.
- Conditions
- Physical Disability
- Being tested
- Life Space Assessment Scale, 6-Minute Push Test, Forward Push Test, Wheelchair Slalom Test, Craig Handicap Assessment and Reporting Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Space Assessment ScaleOther
This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there.
6-Minute Push TestOther
The 6 Minute Push Test is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes.
Forward Push TestOther
This measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score.
Wheelchair Slalom TestOther
In this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter.
Craig Handicap Assessment and Reporting TechniqueOther
A measure of social participation in individuals with SCI.
PART-OOther
The PART-O is a community participation measure.
GPS TrackingOther
A GPS tracker will be attached to the wheelchairs of a subset of participants for one week. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Mobility and Speed | This group will participate in activity-based measures employed in routine occupational and physical therapy practice to assess participants' wheelchair speed, maneuverability, and endurance. These measures include: the Life Space Assessment Scale, 6-Minute Push Test, Forward Push Test, Wheelchair Slalom Test, Craig Handicap Assessment and Reporting Technique, and PART-O. Receives: Other: Life Space Assessment Scale; Other: 6-Minute Push Test; Other: Forward Push Test; Other: Wheelchair Slalom Test; Other: Craig Handicap Assessment and Reporting Technique; Other: PART-O | |
| GPS Tracking | A GPS tracker will be placed on the wheelchairs of 25 individuals who consent to participate in this arm of the project. Using a GPS tracker will provide a direct measure of the community locations these participants go. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement. Receives: Other: Life Space Assessment Scale; Other: 6-Minute Push Test; Other: Forward Push Test; Other: Wheelchair Slalom Test; Other: Craig Handicap Assessment and Reporting Technique; Other: PART-O; Other: GPS Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Space Assessment Scale Score
This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there. The locations vary from spaces within their home, immediately around their home, or outside of their neighborhood, city, county, state or nation. Their independent movement patterns will be classified as within the home, limited community mobility and full community mobility.
Measured: Day 0
Secondary outcomes (3)
Distance (meters) covered in six-minute push test
This is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes
Measured: Day 0
Average time to complete forward push test
This measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score
Measured: Day 0
Time to complete Manual Wheelchair slalom Test
In this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start31 Mar 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: COVID-19 Pandemic made participant recruitment nonfeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Flinn, PhD, OTR/L, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469414
- Sponsor's protocol ID
- CKNF-1703
- Status last verified
- Feb 2021
- First submitted
- 12 Mar 2018
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Wheelchair Speed, Maneuverability, and Endurance and Community Access
- ClinicalTrials.gov ID
- NCT03469414
- Acronym / sponsor ID
- CKNF-1703
- Conditions
- Physical Disability
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic made participant recruitment nonfeasible.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 19 Mar 2018 (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 cross-section correlational study that will examine the relationships between wheelchair speed, maneuverability, and endurance with community integration. By identifying which of these has the biggest contribution to community participation, the information will be used to justify continues therapy, to alter the focus of therapy, and to justify purchase of power or power assist wheelchairs when needed. Currently, therapists make the recommendation for a power or power assist chair based on their clinical judgement and the patient's experience, but there has been limited justification from the literature for these decisions. Finally, because the CHART measure is the gold standard in rehabilitation research for community integration, but has psychometric problems, we will use this opportunity to validate a new more psychometrically solid measure, the PART-O, against the CHART.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Mobility and Speed | – | Other: Life Space Assessment Scale, Other: 6-Minute Push Test, Other: Forward Push Test, Other: Wheelchair Slalom Test, Other: Craig Handicap Assessment and Reporting Technique, Other: PART-OThis group will participate in activity-based measures employed in routine occupational and physical therapy practice to assess participants' wheelchair speed, maneuverability, and endurance. These measures include: the Life Space Assessment Scale, 6-Minute Push Test, Forward Push Test, Wheelchair Slalom Test, Craig Handicap Assessment and Reporting Technique, and PART-O. |
| GPS Tracking | – | Other: Life Space Assessment Scale, Other: 6-Minute Push Test, Other: Forward Push Test, Other: Wheelchair Slalom Test, Other: Craig Handicap Assessment and Reporting Technique, Other: PART-O, Other: GPS TrackingA GPS tracker will be placed on the wheelchairs of 25 individuals who consent to participate in this arm of the project. Using a GPS tracker will provide a direct measure of the community locations these participants go. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 260 participants with disabilities who use manual wheelchairs for their primary mobility. Participants will be recruited from all Courage Kenny Rehabilitation Institute sites. Participants will have a mixture of diagnosis, with a minimum of 30 individuals with diagnosis of stroke and 30 individuals with diagnosis with spinal cord injury.
Key inclusion criteria (4 listed)
- 18 years or older
- presence of a physical disability
- use of a manual wheelchair for primary mobility
- living in the community.
Key exclusion criteria (4 listed)
- individuals who have significant expressive or receptive language deficits (i.e. aphasia, verbal apraxia, etc.)
- limb orthopedic conditions that would contraindicate speed and endurance testing, such as recent fractures or joint instability
- cardiopulmonary resting heart rate of less than 50 or over 100, resting vitals of systolic blood pressure of > 200 or < 90, diastolic blood pressure of >110, resting O2 levels of less than 90 (ACSM, 205; Fletcher, et al., 1993).
- any other cardiac symptoms
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 |
|---|---|---|
| Life Space Assessment ScaleThis nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there. | Other | GPS Tracking, Wheelchair Mobility and Speed |
| 6-Minute Push TestThe 6 Minute Push Test is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes. | Other | GPS Tracking, Wheelchair Mobility and Speed |
| Forward Push TestThis measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score. | Other | GPS Tracking, Wheelchair Mobility and Speed |
| Wheelchair Slalom TestIn this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter. | Other | GPS Tracking, Wheelchair Mobility and Speed |
| Craig Handicap Assessment and Reporting TechniqueA measure of social participation in individuals with SCI. | Other | GPS Tracking, Wheelchair Mobility and Speed |
| PART-OThe PART-O is a community participation measure. | Other | GPS Tracking, Wheelchair Mobility and Speed |
| GPS TrackingA GPS tracker will be attached to the wheelchairs of a subset of participants for one week. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement. | Other | GPS Tracking |
Primary outcome
Life Space Assessment Scale Score
Time frame: Day 0
This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there. The locations vary from spaces within their home, immediately around their home, or outside of their neighborhood, city, county, state or nation. Their independent movement patterns will be classified as within the home, limited community mobility and full community mobility.
3 secondary outcomes
Distance (meters) covered in six-minute push test
Time frame: Day 0
Average time to complete forward push test
Time frame: Day 0
Time to complete Manual Wheelchair slalom Test
Time frame: Day 0
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic made participant recruitment nonfeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Physical Disability
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
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.
Nancy Flinn, PhD, OTR/L principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disability, run by Allina Health System at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Feb 2021. 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 United States. 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 was stopped early (reason given: COVID-19 Pandemic made participant recruitment nonfeasible.). Results are not available in the source record.
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?
Life Space Assessment Scale Score (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.