StrokeNCT02969967
Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke
A study testing SaeboFlex in people with Stroke, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity recovery for people in the early phases of rehabilitation post stroke. The objectives of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- SaeboFlex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Jun 2017
- 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
- adults aged 18 or over who have had a first stroke within the past 6 months
- admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
- fit with and started using a custom SaeboFlex orthosis as an inpatient at Riverview Health Centre after having met the active and passive movement criteria required to use the SaeboFlex orthosis
- referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for ongoing upper extremity rehabilitation using a SaeboFlex orthosis
- able to commit to the time requirements of the study
- have a premorbid fully functional upper extremity
Show all 10Show fewer
- able to speak and understand English
- able to follow multistep commands and understand the purpose and required use of the orthosis
- able to stand for at least 10 minutes
- have 3 times per week access to a caregiver to assist with donning the orthosis at home if required
Who cannot join
- Chedoke McMaster Stroke Assessment, Impairment Inventory (Shoulder Pain section) score of 1-3
- score of 3 or more on the Modified Ashworth Scale for elbow, wrist or finger flexors
- swan neck deformities or contractures of the fingers or wrist of the paretic upper extremity
- history of skin breakdown on the paretic upper extremity or a score of less than 6 out of 12 on the Sensation Section of the Fugl-Meyer Upper Extremity Assessment
- significant cognitive impairment as determined by a score of 21 or less on the Montreal Cognitive Assessment
- able to fully extend fingers 10 times in a position of maximal shoulder flexion and elbow extension with a neutral wrist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke: a Multiple Single Subject Design Evaluation
The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity recovery for people in the early phases of rehabilitation post stroke. The objectives of the study are:
- to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity function, strength, movement, spasticity and self-perceived occupational performance, in addition to conventional therapy, with continued use immediately after discharge from inpatient stroke rehabilitation and while waiting for outpatient occupational therapy services
- to explore the relationship between the participants' level of self-efficacy and use of the SaeboFlex orthosis in the home environment
- to explore the participants' experience of use of the SaeboFlex orthosis in the home environment.
Read the detailed description
Although intensive and repetitive use of the paretic upper extremity has been shown to improve upper extremity outcomes post stroke, few therapeutic approaches allow those with moderate to severe upper extremity impairment to independently participate in repetitive grasp and release activities. The SaeboFlex orthosis is a dynamic wrist-hand orthosis that assists with finger and thumb extension after functional grasping with the paretic hand and therefore may allow those with more affected upper extremities post stroke to participate in repetitive grasp and release activities that they otherwise would be unable to do. More research is required on the effectiveness of this orthosis in improving upper extremity recovery post stroke especially when used at home as a continuation of therapy received during inpatient rehabilitation. It has been suggested that guided home rehabilitation programs can improve the ability of stroke survivors to be more independent in their activities of daily living. This study is a mixed methods study combining a quantitative single subject ABA design and qualitative post study individual interviews to first capture quantitative information on the effectiveness of the SaeboFlex intervention and then qualitative information that will build on and further explain the quantitative data. Three participants who are using a SaeboFlex orthosis as part of their upper extremity rehabilitation program will be recruited from an inpatient stroke rehabilitation unit as they are being discharged from inpatient rehabilitation and will be seen by the principal investigator in their homes for 1 hour 3 times a week for 2 weeks and then once a week for 6 weeks while they are on the waiting list for outpatient occupational therapy services. The intervention will follow a set protocol of grasp-release activities using the SaeboFlex orthosis for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis, both of which will be graded to provide optimal upper extremity challenge throughout the intervention period. Repeated baseline assessments will be completed by a trained research assistant, in the participants' homes, within one week of discharge from inpatient stroke rehabilitation and will be repeated after 4 and 8 weeks of intervention, followed by individual interviews in the participants' homes.
- Conditions
- Stroke
- Being tested
- SaeboFlex
- Keywords
- rehabilitation, upper extremity, orthosis, SaeboFlex
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaeboFlexDevice
Also called functional dynamic orthosis
Use of the SaeboFlex orthosis for a set protocol of grasp-release activities for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis for 8 weeks. Will occur in participants' homes after discharge from inpatient rehabilitation with visit from principal investigator to progress program for 1 hour 3 times a week for the first 2 weeks and then once a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SaeboFlex | Experimental | Use of the SaeboFlex orthosis for a set protocol of grasp-release activities Receives: Device: SaeboFlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Activity Measure (ArmA)
The Arm Activity Measure (ArmA) is a self-report tool designed for use with upper extremity spasticity management interventions. The ArmA was chosen because it provides a comprehensive assessment at the activity level of both active and passive upper extremity function; it is comprised of an 8 item passive function subscale and a 13 item active function subscale. Both subscales have been found to have high internal consistency and test-retest reliability.
Measured: Change from baseline upper extremity function to 4 and 8 weeks
Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7)
The Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7) is a commonly used upper extremity functional assessment post stroke. It is comprised of seven bilateral functional tasks and has been found to have excellent test-retest and inter-rater reliability as well as internal consistency.
Measured: Change from baseline upper extremity function to 4 and 8 weeks
Secondary outcomes (6)
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a widely used measure of motor impairment post stroke and is comprised of 33 items related to upper extremity movement. The FMA-UE has excellent inter-rater and test-retest reliability as well as construct validity in persons with stroke.
Measured: Change from baseline upper extremity impairment to 4 and 8 weeks
Stroke Impact Scale (SIS)
The Stroke Impact Scale (SIS) is a well known and well studied measure of stroke survivors' perception of their recovery post stroke. The SIS has been widely used in stroke intervention studies.
Measured: Change from baseline perception of recovery to 4 and 8 weeks
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a well known measure of spasticity post stroke. The MAS assesses the resistance to passive muscle stretch and is graded on a 6 point ordinal scale. The participants' elbow, wrist and finger flexors will be assessed with the MAS.
Measured: Change from baseline spasticity to 4 and 8 weeks
Hand Grip Strength (measured using dynamometry)
Measurement of hand grip strength using dynamometry is common post stroke and has excellent test-retest and inter-rater reliability. An average of 3 grip strength trials will be taken at each measurement point using dynamometry.
Measured: Change from baseline grip strength to 4 and 8 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
The Stroke Self-Efficacy Questionnaire (SSEQ) was designed to assess self-efficacy related to functional performance and self-management post stroke. The SSEQ is comprised of two subscales that are scored separately and correlate strongly with other measures of self-efficacy post stroke.
Measured: Change from baseline self-efficacy to 4 and 8 weeks
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) is a valid and responsive measure of occupational performance and has been widely used in stroke research. The COPM uses a semi-structured interview format where performance and satisfaction scores will be identified for the participants' self-identified occupational performance issues.
Measured: Change from baseline perception of occupational performance to 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda L Semenko, BMR (OT), Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969967
- Sponsor's protocol ID
- H2016:285
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
PubMed 20424192Waddell KJ, Birkenmeier RL, Moore JL, Hornby TG, Lang CE. Feasibility of high-repetition, task-specific training for individuals with upper-extremity paresis. Am J Occup Ther. 2014 Jul-Aug;68(4):444-53. doi: 10.5014/ajot.2014.011619.
PubMed 25005508Butler A, Blanton S, Rowe V, Wolf S. Attempting to improve function and quality of life using the FTM Protocol: case report. J Neurol Phys Ther. 2006 Sep;30(3):148-56. doi: 10.1097/01.npt.0000281952.93934.6b.
PubMed 17029658Legg L, Langhorne P; Outpatient Service Trialists. Rehabilitation therapy services for stroke patients living at home: systematic review of randomised trials. Lancet. 2004 Jan 31;363(9406):352-6. doi: 10.1016/S0140-6736(04)15434-2.
PubMed 15070563
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke: a Multiple Single Subject Design Evaluation
- ClinicalTrials.gov ID
- NCT02969967
- Acronym / sponsor ID
- H2016:285
- Conditions
- Stroke
- Keywords
- rehabilitation, upper extremity, orthosis, SaeboFlex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Nov 2016 (estimated)
- 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.
The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity recovery for people in the early phases of rehabilitation post stroke. The objectives of the study are:
- to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity function, strength, movement, spasticity and self-perceived occupational performance, in addition to conventional therapy, with continued use immediately after discharge from inpatient stroke rehabilitation and while waiting for outpatient occupational therapy services
- to explore the relationship between the participants' level of self-efficacy and use of the SaeboFlex orthosis in the home environment
- to explore the participants' experience of use of the SaeboFlex orthosis in the home environment.
Detailed description
Although intensive and repetitive use of the paretic upper extremity has been shown to improve upper extremity outcomes post stroke, few therapeutic approaches allow those with moderate to severe upper extremity impairment to independently participate in repetitive grasp and release activities. The SaeboFlex orthosis is a dynamic wrist-hand orthosis that assists with finger and thumb extension after functional grasping with the paretic hand and therefore may allow those with more affected upper extremities post stroke to participate in repetitive grasp and release activities that they otherwise would be unable to do. More research is required on the effectiveness of this orthosis in improving upper extremity recovery post stroke especially when used at home as a continuation of therapy received during inpatient rehabilitation. It has been suggested that guided home rehabilitation programs can improve the ability of stroke survivors to be more independent in their activities of daily living. This study is a mixed methods study combining a quantitative single subject ABA design and qualitative post study individual interviews to first capture quantitative information on the effectiveness of the SaeboFlex intervention and then qualitative information that will build on and further explain the quantitative data. Three participants who are using a SaeboFlex orthosis as part of their upper extremity rehabilitation program will be recruited from an inpatient stroke rehabilitation unit as they are being discharged from inpatient rehabilitation and will be seen by the principal investigator in their homes for 1 hour 3 times a week for 2 weeks and then once a week for 6 weeks while they are on the waiting list for outpatient occupational therapy services. The intervention will follow a set protocol of grasp-release activities using the SaeboFlex orthosis for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis, both of which will be graded to provide optimal upper extremity challenge throughout the intervention period. Repeated baseline assessments will be completed by a trained research assistant, in the participants' homes, within one week of discharge from inpatient stroke rehabilitation and will be repeated after 4 and 8 weeks of intervention, followed by individual interviews in the participants' homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SaeboFlex | Experimental | Device: SaeboFlexUse of the SaeboFlex orthosis for a set protocol of grasp-release activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adults aged 18 or over who have had a first stroke within the past 6 months
- admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
- fit with and started using a custom SaeboFlex orthosis as an inpatient at Riverview Health Centre after having met the active and passive movement criteria required to use the SaeboFlex orthosis
- referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for ongoing upper extremity rehabilitation using a SaeboFlex orthosis
- able to commit to the time requirements of the study
Key exclusion criteria (6 listed)
- Chedoke McMaster Stroke Assessment, Impairment Inventory (Shoulder Pain section) score of 1-3
- score of 3 or more on the Modified Ashworth Scale for elbow, wrist or finger flexors
- swan neck deformities or contractures of the fingers or wrist of the paretic upper extremity
- history of skin breakdown on the paretic upper extremity or a score of less than 6 out of 12 on the Sensation Section of the Fugl-Meyer Upper Extremity Assessment
- significant cognitive impairment as determined by a score of 21 or less on the Montreal Cognitive Assessment
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 |
|---|---|---|
| SaeboFlexAlso: functional dynamic orthosisUse of the SaeboFlex orthosis for a set protocol of grasp-release activities for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis for 8 weeks. Will occur in participants' homes after discharge from inpatient rehabilitation with visit from principal investigator to progress program for 1 hour 3 times a week for the first 2 weeks and then once a week for 6 weeks. | Device | SaeboFlex |
Primary outcome
Arm Activity Measure (ArmA)
Time frame: Change from baseline upper extremity function to 4 and 8 weeks
The Arm Activity Measure (ArmA) is a self-report tool designed for use with upper extremity spasticity management interventions. The ArmA was chosen because it provides a comprehensive assessment at the activity level of both active and passive upper extremity function; it is comprised of an 8 item passive function subscale and a 13 item active function subscale. Both subscales have been found to have high internal consistency and test-retest reliability.
Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7)
Time frame: Change from baseline upper extremity function to 4 and 8 weeks
The Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7) is a commonly used upper extremity functional assessment post stroke. It is comprised of seven bilateral functional tasks and has been found to have excellent test-retest and inter-rater reliability as well as internal consistency.
6 secondary outcomes
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time frame: Change from baseline upper extremity impairment to 4 and 8 weeks
Stroke Impact Scale (SIS)
Time frame: Change from baseline perception of recovery to 4 and 8 weeks
Modified Ashworth Scale (MAS)
Time frame: Change from baseline spasticity to 4 and 8 weeks
Hand Grip Strength (measured using dynamometry)
Time frame: Change from baseline grip strength to 4 and 8 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
Time frame: Change from baseline self-efficacy to 4 and 8 weeks
Canadian Occupational Performance Measure (COPM)
Time frame: Change from baseline perception of occupational performance to 4 and 8 weeks
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 2 Dec 2017.
- Background: PubMed 20424192Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
- Background: PubMed 25005508Waddell KJ, Birkenmeier RL, Moore JL, Hornby TG, Lang CE. Feasibility of high-repetition, task-specific training for individuals with upper-extremity paresis. Am J Occup Ther. 2014 Jul-Aug;68(4):444-53. doi: 10.5014/ajot.2014.011619.
- Background: PubMed 17029658Butler A, Blanton S, Rowe V, Wolf S. Attempting to improve function and quality of life using the FTM Protocol: case report. J Neurol Phys Ther. 2006 Sep;30(3):148-56. doi: 10.1097/01.npt.0000281952.93934.6b.
- Background: PubMed 15070563Legg L, Langhorne P; Outpatient Service Trialists. Rehabilitation therapy services for stroke patients living at home: systematic review of randomised trials. Lancet. 2004 Jan 31;363(9406):352-6. doi: 10.1016/S0140-6736(04)15434-2.
- 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.
Brenda L Semenko, BMR (OT) principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaeboFlex in people with Stroke, run by University of Manitoba at 1 site in Canada.
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 10 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 2 Dec 2017. 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 Canada. 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?
Arm Activity Measure (ArmA) (time frame: Change from baseline upper extremity function to 4 and 8 weeks). The study lists 2 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 NCT02969967, which also lists 4 linked publications.
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 2 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.