StrokeNCT04015271
Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
A study testing Action Observation + Repetitive Task Practice in people with Stroke and Hemiparesis, run by Ohio State University at 1 site in United States.
Trial summary
The objective of this pilot randomized controlled single blinded, parallel-group study is to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Action Observation + Repetitive Task Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 31 Dec 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced a stroke resulting in a Upper Extremity Fugl Meyer score >17 < 49
- Experienced a post stroke > 6 months
- > 24 on the Folstein Mini Mental Status Examination
- Experienced only one stroke
- Discharged from all forms of physical rehabilitation intervention
- Visual acuity of 20/50 or greater with or without corrective lenses
Show all 10Show fewer
- > 19 on the Hooper Visual Organization Test
- Unilateral stroke only
- Cerebral stroke
- Age of onset of stroke greater than 18 years old.
Who cannot join
- < 18 years old
- > 5 on a 10-point visual analog pain scale in the affected UL
- > 2 on the Modified Ashworth Scale in the affected UL to exclude individuals with hypertonia, spasticity, joint rigidity, and joint contracture
- Participating in any experimental rehabilitation or drug studies
- Uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
- Neurological disorder other than stroke
Show all 9Show fewer
- > 31 on Beck Depression Inventory ("Severe Depression")
- Unable to regularly attend treatment sessions and follow-up due to distance from the center or inadequate social support
- Cerebellar stroke with ataxia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
The objective of this pilot randomized controlled single blinded, parallel-group study is to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired stroke survivors.
Read the detailed description
The current proposal aims to conduct a pilot randomized controlled single blinded, parallel-group study design to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb (UL) motor impairment outcomes in the chronic, moderately impaired stroke survivor. Individuals will be randomized to 1) experimental conditions of AO + RTP practice schedule, or 2) control condition of Placebo Video (PV) + RTP, and will receive an assigned regimen from a blinded intervention therapist for one hour, 3 times per week, for 8 weeks (total of 24 sessions), and a daily 30 minute HEP. A blinded assessor will complete assessments on each subject at three distinct time points of pretest, post intervention, and 1 month post intervention.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Action Observation + Repetitive Task Practice, Placebo Video + Repetitive Task Practice
- Keywords
- stroke, hemiparesis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation + Repetitive Task PracticeBehavioural
Observing a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis
Placebo Video + Repetitive Task PracticeBehavioural
Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
| Study group | Role | What they receive |
|---|---|---|
| Action Observation + Repetitive Task Practice | Experimental | Action Observation (AO) therapy regimen will include watching a 6 minute video of another person completing a specified functional task (Putting on a shirt, pick up a sandwich and bring to mouth, eat food with a spoon, or cut meat with knife and fork). Subjects will be instructed to carefully watch the AO video and prepare to physically perform the task immediately after observing the video. The Repetitive Task Practice (RTP) therapy regimen emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task that is matched to the AO recording. The AO + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions. Receives: Behavioral: Action Observation + Repetitive Task Practice |
| Placebo Video + Repetitive Task Practice | Placebo comparator | The control placebo videos (PV) will be 6 minutes, and will include a series of changing static images without animals, human beings, or sound (i.e. pictures of buildings, trees, cruise ships, mountains, beach umbrellas, beds, and tables). A Repetitive Task Practice (RTP) therapy regimen will be completed immediately after observing the PV, which emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task. These tasks include putting on a shirt, picking up a sandwich and bringing it to mouth, eating food with a spoon, or cutting meat with knife and fork. The PV + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions. Receives: Behavioral: Placebo Video + Repetitive Task Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
Assessment to evaluate motor impairment of the hemiplegic upper limb. Multiple time points will be used to asses the change in motor impairment. Items are scored on a 3 point ordinal scale (0 = cannot perform, 2 = can perform fully), and are totaled for a maximum of 66 possible points.
Measured: Pretest, immediately after the intervention, and 1 month post intervention
Secondary outcomes (11)
Change from Baseline in the The Arm Motor Ability Test
Assessment to evaluate function during activities of daily living of the hemiplegic upper limb
Measured: Pretest, immediately after the intervention, and 1 month post intervention
Change from Baseline in the Motor Activity Log
Assessment to evaluate the activity limitation of hemiplegic upper limb functional use in the community
Measured: Pretest, immediately after the intervention, and 1 month post intervention
Change from baseline in smoothness of movements measured by three-axis accelerometer
A Fitbit will be used to quantify the amount of upper limb motor activity during an intervention session and heart rate
Measured: Each session (3 times per week) during 8 week intervention
Change from Baseline in Stroke Impact Scale 2.0
Assessment to evaluate motor and functional changes in the hemiplegic upper. It is a 64-item self-report measure assessing 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation).A low score indicates a high impact on quality of life.
Measured: Pretest, immediately after the intervention, and 1 month post intervention
Survey to assess subjects experience in the study
A survey to examine the perceived experience of the intervention for subjects participating in the study. Subjects will answer on a 5 point ordinal scale (1 = Strongly disagree, 5 = Strongly Agree), and open ended questions will be descriptive questions to explain response on ordinal scale.
Measured: immediately after the intervention, and 1 month post intervention
Daily Diary
A diary to measure everyday application of functional tasks learned in the protocol and compliance with HEP
Measured: Each day during 8 week intervention
Number of trials/ repetitions per task
Measurement of the number of times a subject completes a task in a one hour session
Measured: Each session (3 times per week) during 8 week intervention
Change in Movement time to complete task
Measure the amount of time required for a subject to complete a task during performance of task
Measured: Each session (3 times per week) during 8 week intervention
Change in Amount of physical assist to perform task
Measure how much assistance a subject requires to complete a task. Amount will be measured in the categories of tactile cue, 1 hand assistance, 2 hand assistance
Measured: Each session (3 times per week) during 8 week intervention
Change in Number of verbal cues given to perform task
Measure the number of verbal cues that are required for a subject to perform a task
Measured: Each session (3 times per week) during 8 week intervention
Change in the number of errors during task performance
Measure the number of errors that a subject demonstrates while performing a task
Measured: Each session (3 times per week) during 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start27 Jun 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 StrokeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized controlled single blinded, parallel-group study design
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Buford, PT, PhD, Ohio State University
- Investigators
- John Buford, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015271
- Sponsor's protocol ID
- 2019H0197
- Status last verified
- Mar 2020
- First submitted
- 2 Jul 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borges LR, Fernandes AB, Oliveira Dos Passos J, Rego IAO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2022 Aug 5;8(8):CD011887. doi: 10.1002/14651858.CD011887.pub3.
PubMed 35930301
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Action Observation and Repetitive Task Practice Combined Practice Schedule on Upper Extremity Outcomes in Moderately Impaired Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT04015271
- Acronym / sponsor ID
- 2019H0197
- Conditions
- Stroke, Hemiparesis
- Keywords
- stroke, hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Jul 2019 (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.
The objective of this pilot randomized controlled single blinded, parallel-group study is to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired stroke survivors.
Detailed description
The current proposal aims to conduct a pilot randomized controlled single blinded, parallel-group study design to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb (UL) motor impairment outcomes in the chronic, moderately impaired stroke survivor. Individuals will be randomized to 1) experimental conditions of AO + RTP practice schedule, or 2) control condition of Placebo Video (PV) + RTP, and will receive an assigned regimen from a blinded intervention therapist for one hour, 3 times per week, for 8 weeks (total of 24 sessions), and a daily 30 minute HEP. A blinded assessor will complete assessments on each subject at three distinct time points of pretest, post intervention, and 1 month post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A pilot randomized controlled single blinded, parallel-group study design
| Arm | Type | Receives |
|---|---|---|
| Action Observation + Repetitive Task Practice | Experimental | Behavioral: Action Observation + Repetitive Task PracticeAction Observation (AO) therapy regimen will include watching a 6 minute video of another person completing a specified functional task (Putting on a shirt, pick up a sandwich and bring to mouth, eat food with a spoon, or cut meat with knife and fork). Subjects will be instructed to carefully watch the AO video and prepare to physically perform the task immediately after observing the video. The Repetitive Task Practice (RTP) therapy regimen emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task that is matched to the AO recording. The AO + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions. |
| Placebo Video + Repetitive Task Practice | Placebo comparator | Behavioral: Placebo Video + Repetitive Task PracticeThe control placebo videos (PV) will be 6 minutes, and will include a series of changing static images without animals, human beings, or sound (i.e. pictures of buildings, trees, cruise ships, mountains, beach umbrellas, beds, and tables). A Repetitive Task Practice (RTP) therapy regimen will be completed immediately after observing the PV, which emphasizes repeated physical performance with the hemiplegic upper limb for 24 minutes of a specified functional task. These tasks include putting on a shirt, picking up a sandwich and bringing it to mouth, eating food with a spoon, or cutting meat with knife and fork. The PV + RTP regimens will be repeated for a total of 60 minutes. Each Subject will complete a Home Exercise Program (HEP) will include practicing components and movement patterns of the functional task that was difficult for the patient to perform during RTP intervention for 30 minutes each day outside of scheduled intervention sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Experienced a stroke resulting in a Upper Extremity Fugl Meyer score >17 < 49
- Experienced a post stroke > 6 months
- > 24 on the Folstein Mini Mental Status Examination
- Experienced only one stroke
- Discharged from all forms of physical rehabilitation intervention
Key exclusion criteria (9 listed)
- < 18 years old
- > 5 on a 10-point visual analog pain scale in the affected UL
- > 2 on the Modified Ashworth Scale in the affected UL to exclude individuals with hypertonia, spasticity, joint rigidity, and joint contracture
- Participating in any experimental rehabilitation or drug studies
- Uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
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 |
|---|---|---|
| Action Observation + Repetitive Task PracticeObserving a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis | Behavioural | Action Observation + Repetitive Task Practice |
| Placebo Video + Repetitive Task PracticeObserving a video of static images and physically repetitively performing functional task for upper extremity hemiparesis | Behavioural | Placebo Video + Repetitive Task Practice |
Primary outcome
Change from Baseline in Upper extremity section of the Fugl-Meyer Scale
Time frame: Pretest, immediately after the intervention, and 1 month post intervention
Assessment to evaluate motor impairment of the hemiplegic upper limb. Multiple time points will be used to asses the change in motor impairment. Items are scored on a 3 point ordinal scale (0 = cannot perform, 2 = can perform fully), and are totaled for a maximum of 66 possible points.
11 secondary outcomes
Change from Baseline in the The Arm Motor Ability Test
Time frame: Pretest, immediately after the intervention, and 1 month post intervention
Change from Baseline in the Motor Activity Log
Time frame: Pretest, immediately after the intervention, and 1 month post intervention
Change from baseline in smoothness of movements measured by three-axis accelerometer
Time frame: Each session (3 times per week) during 8 week intervention
Change from Baseline in Stroke Impact Scale 2.0
Time frame: Pretest, immediately after the intervention, and 1 month post intervention
Survey to assess subjects experience in the study
Time frame: immediately after the intervention, and 1 month post intervention
Daily Diary
Time frame: Each day during 8 week intervention
Number of trials/ repetitions per task
Time frame: Each session (3 times per week) during 8 week intervention
Change in Movement time to complete task
Time frame: Each session (3 times per week) during 8 week intervention
Change in Amount of physical assist to perform task
Time frame: Each session (3 times per week) during 8 week intervention
Change in Number of verbal cues given to perform task
Time frame: Each session (3 times per week) during 8 week intervention
Change in the number of errors during task performance
Time frame: Each session (3 times per week) during 8 week intervention
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 4 Mar 2020.
- Derived from this study: PubMed 35930301Borges LR, Fernandes AB, Oliveira Dos Passos J, Rego IAO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2022 Aug 5;8(8):CD011887. doi: 10.1002/14651858.CD011887.pub3.
- 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.
John Buford, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation + Repetitive Task Practice in people with Stroke and Hemiparesis, run by Ohio State University 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 10 inclusion and 9 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 4 Mar 2020. 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. Some participants in this study may receive a placebo. 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 from Baseline in Upper extremity section of the Fugl-Meyer Scale (time frame: Pretest, immediately after the intervention, and 1 month post intervention). 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 NCT04015271, 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 4 Mar 2020.