Feedback Intervention (Participants Post-stroke)UnSumRes2015NCT02995200
Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting
A study testing Accelerometer Based Feedback in people with Feedback Intervention (Participants Post-stroke) and Healthy Control, run by Cleveland State University.
Trial summary
A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Feedback Intervention (Participants Post-stroke), Healthy Control
- What is being tested?
- Accelerometer Based Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adults: 40-100 years old, able to follow 2-step commands, able to comply with experimental protocol, living in a home setting, full active range of motion (AROM) in both shoulders and elbows for their age group.
- Individuals Post-stroke: Able to follow 2-step commands, 40 - 100 years old, community dwelling with or without assistance, no upper extremity (UE) injury within the last 3 months, at least 30 degrees of flexion AROM (with or without assistance) and PROM in shoulder and elbow in or out of synergy, intact superficial light touch sensation in both UEs, and at least 6 months post ischemic or hemorrhagic stroke that is either cortical, subcortical or in the cerebellum. It does not need to be their first and only stroke.
Who cannot join
- Healthy Adults: Injury of either UE within the last 3 months and unable to follow commands related to the accelerometer use/protocol.
- Individuals Post-stroke: Unable to follow 2 step commands, inability to adhere to study requirements, any neurological diagnosis other than stroke (i.e. Parkinson's Disease, Multiple Sclerosis, etc.), and aphasia limiting their ability to complete the MoCA and Stroke Impact Scale (SIS) questions.
About this study
A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:
i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in healthy individuals and individuals chronic post-stroke,
Read more
ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs,
iii.) quantify and compare amount of UE use in healthy controls to that of people chronic post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and
iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.
v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between healthy controls and subjects post-chronic stroke pre and post feedback (for the people after stroke).
- Being tested
- Accelerometer Based Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer Based FeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group Post-Stroke | Experimental | 2 sessions of in-home accelerometer based feedback about paretic arm use Receives: Behavioral: Accelerometer Based Feedback |
| Healthy Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Use (measured by accelerometer)
Measured: 3 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feedback Intervention (Participants Post-stroke)Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen Whitford, Cleveland State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995200
- Sponsor's protocol ID
- IRB-FY2016-182
- Acronym
- UnSumRes2015
- Status last verified
- Sep 2017
- First submitted
- 14 Dec 2016
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Upper Extremity Use and Effects of Feedback in the Home Setting
- ClinicalTrials.gov ID
- NCT02995200
- Acronym / sponsor ID
- UnSumRes2015 / IRB-FY2016-182
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cleveland State UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 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.
A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:
i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in healthy individuals and individuals chronic post-stroke,
ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs,
iii.) quantify and compare amount of UE use in healthy controls to that of people chronic post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and
iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.
v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between healthy controls and subjects post-chronic stroke pre and post feedback (for the people after stroke).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Post-Stroke | Experimental | Behavioral: Accelerometer Based Feedback2 sessions of in-home accelerometer based feedback about paretic arm use |
| Healthy Control Group | No intervention | – |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Adults: 40-100 years old, able to follow 2-step commands, able to comply with experimental protocol, living in a home setting, full active range of motion (AROM) in both shoulders and elbows for their age group.
- Individuals Post-stroke: Able to follow 2-step commands, 40 - 100 years old, community dwelling with or without assistance, no upper extremity (UE) injury within the last 3 months, at least 30 degrees of flexion AROM (with or without assistance) and PROM in shoulder and elbow in or out of synergy, intact superficial light touch sensation in both UEs, and at least 6 months post ischemic or hemorrhagic stroke that is either cortical, subcortical or in the cerebellum. It does not need to be their first and only stroke.
Key exclusion criteria (2 listed)
- Healthy Adults: Injury of either UE within the last 3 months and unable to follow commands related to the accelerometer use/protocol.
- Individuals Post-stroke: Unable to follow 2 step commands, inability to adhere to study requirements, any neurological diagnosis other than stroke (i.e. Parkinson's Disease, Multiple Sclerosis, etc.), and aphasia limiting their ability to complete the MoCA and Stroke Impact Scale (SIS) questions.
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 |
|---|---|---|
| Accelerometer Based Feedback | Behavioural | Group Post-Stroke |
Primary outcome
Amount of Use (measured by accelerometer)
Time frame: 3 week period
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 26 Sep 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer Based Feedback in people with Feedback Intervention (Participants Post-stroke) and Healthy Control, run by Cleveland State University.
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 2 inclusion and 2 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 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Amount of Use (measured by accelerometer) (time frame: 3 week period). 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 26 Sep 2017.