Chronic StrokeTERTAOTNCT03780296
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
A study testing Real-time action observation with augmented Kinect in people with Chronic Stroke and Hemiplegia, run by University of Michigan at 1 site in United States.
Trial summary
This is a feasibility study to alter the Microsoft Kinect software to be used as a rehabilitation tool. The prototype used is still in the early developing stage. The purpose of this research study is to develop a prototype of altered Microsoft Kinect Software and determine its use in improving the function of the… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Stroke, Hemiplegia, Hemiparesis
- What is being tested?
- Real-time action observation with augmented Kinect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 26 Sep 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Adults 40 years of age and older having had a stroke greater than 6-months post onset
- Able to follow commands in English
- Medically stable and without acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with walking and light activities
- Able to stand up off of a standard height chair (16-18 inches)
Who cannot join
- - Cognitive impairment as measured by a score below 24/30 on Mini Mental State Examination
- A diagnoses of cancer involving the nervous or musculoskeletal system
- Severe pain in arms, legs, or spine measured by >6/10 using Verbal Numerical Pain Rating Scale that prevents them from standing or walking independently
- Diagnoses of other neurological diseases except for stroke, such as spinal cord injury or Parkinson's disease etc.
- Individuals at the advanced stage of a disease and with less than 12 months to live.
Trial locations and contacts
1 site in 1 country.
About this study
This is a feasibility study to alter the Microsoft Kinect software to be used as a rehabilitation tool. The prototype used is still in the early developing stage. The purpose of this research study is to develop a prototype of altered Microsoft Kinect Software and determine its use in improving the function of the study subjects' weaker extremities. The altered software will allow a viewing of the mirror image of the involved limb as it is moved. However, the image that is viewed will reflect normal movement even if the limb cannot move normally. By viewing normal movement of the weaker limbs the "mirror neuron" network in the brain will become activated and will ultimately improve the function of the weaker side.
- Conditions
- Chronic Stroke, Hemiplegia, Hemiparesis, Paralysis
- Being tested
- Real-time action observation with augmented Kinect
- Keywords
- Kinect, Rehabilitation, Virtual reality, Mirror therapy
- Medical subject headings
- Hemiplegia, Paresis, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time action observation with augmented KinectDevice
Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Action Observation with augmented Kinect | Experimental | Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises. Receives: Device: Real-time action observation with augmented Kinect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor Activity Log (MAL)
MAL measures participants overall use or increased use and quality of use of affected upper limb
Measured: 5 months
Change in 9 Hole Peg Test (9HPT)
9 HPT is a timed standardized measure participants overall function of dexterity.
Measured: 5 months
Change in 10 Meter Walk Test (10mWT)
The 10mWT is a standardized measure used to assess participants timed walking speed in meters per second over a short distance
Measured: 5 months
Change in Functional Reach Test (FRT)
The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm
Measured: 5 months
Change in Timed Up and Go (TUG)
The TUG is a standardized measure which assesses participants mobility, balance, walking ability, and fall risk in older adults
Measured: 5 months
Change in 5 Time Sit to Stand (5xSS)
This is a standardized measure assessing participants functional lower limb strength.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Sep 2017
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre-test/post-test design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan-Flint
- Responsible party
- Principal investigator, Mary Roberts, University of Michigan
- Investigators
- Hendrika L Lietz, PT, DPT, NCS, Study chair, Michigan Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780296
- Sponsor's protocol ID
- HUM00121813
- Acronym
- TERTAOT
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Dissemination at local, state and national conferences via platform and poster presentations. Share upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03780296
- Acronym / sponsor ID
- TERTAOT / HUM00121813
- Conditions
- Chronic Stroke, Hemiplegia, Hemiparesis, Paralysis
- Keywords
- Kinect, Rehabilitation, Virtual reality, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Michigan-Flint
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 19 Dec 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 feasibility study to alter the Microsoft Kinect software to be used as a rehabilitation tool. The prototype used is still in the early developing stage. The purpose of this research study is to develop a prototype of altered Microsoft Kinect Software and determine its use in improving the function of the study subjects' weaker extremities. The altered software will allow a viewing of the mirror image of the involved limb as it is moved. However, the image that is viewed will reflect normal movement even if the limb cannot move normally. By viewing normal movement of the weaker limbs the "mirror neuron" network in the brain will become activated and will ultimately improve the function of the weaker side.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre-test/post-test design
| Arm | Type | Receives |
|---|---|---|
| Real-Time Action Observation with augmented Kinect | Experimental | Device: Real-time action observation with augmented KinectParticipants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Adults 40 years of age and older having had a stroke greater than 6-months post onset
- Able to follow commands in English
- Medically stable and without acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with walking and light activities
- Able to stand up off of a standard height chair (16-18 inches)
Key exclusion criteria (5 listed)
- - Cognitive impairment as measured by a score below 24/30 on Mini Mental State Examination
- A diagnoses of cancer involving the nervous or musculoskeletal system
- Severe pain in arms, legs, or spine measured by >6/10 using Verbal Numerical Pain Rating Scale that prevents them from standing or walking independently
- Diagnoses of other neurological diseases except for stroke, such as spinal cord injury or Parkinson's disease etc.
- Individuals at the advanced stage of a disease and with less than 12 months to live.
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 |
|---|---|---|
| Real-time action observation with augmented KinectParticipants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises. | Device | Real-Time Action Observation with augmented Kinect |
Primary outcome
Change in Motor Activity Log (MAL)
Time frame: 5 months
MAL measures participants overall use or increased use and quality of use of affected upper limb
Change in 9 Hole Peg Test (9HPT)
Time frame: 5 months
9 HPT is a timed standardized measure participants overall function of dexterity.
Change in 10 Meter Walk Test (10mWT)
Time frame: 5 months
The 10mWT is a standardized measure used to assess participants timed walking speed in meters per second over a short distance
Change in Functional Reach Test (FRT)
Time frame: 5 months
The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm
Change in Timed Up and Go (TUG)
Time frame: 5 months
The TUG is a standardized measure which assesses participants mobility, balance, walking ability, and fall risk in older adults
Change in 5 Time Sit to Stand (5xSS)
Time frame: 5 months
This is a standardized measure assessing participants functional lower limb strength.
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 19 Dec 2018.
- Individual participant dataSharing planned: Yes. Dissemination at local, state and national conferences via platform and poster presentations. Share upon request.
Related trials for Chronic Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Lumbar Spinal Manipulation in Stroke
Stroke
Recruiting
Effect of Lower Limb Proprioceptive Neuromuscular Facilitation Combined With Core Stability Training Versus Proprioceptive Neuromuscular Facilitation Alone on Balance and Functional Mobility in Chronic Stroke Survivors
Stroke
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Recruiting
Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Chronic Stroke
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.
Hendrika L Lietz, PT, DPT, NCS study chair
Michigan Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time action observation with augmented Kinect in people with Chronic Stroke and Hemiplegia, run by University of Michigan 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 5 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 19 Dec 2018. 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 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 Motor Activity Log (MAL) (time frame: 5 months). The study lists 6 primary outcomes in all. 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 19 Dec 2018.