StrokeTARGNCT01819506
Patient Targeted Upper Extremity Rehabilitation After Stroke
A study testing Task Practice Physical Rehabilitation Therapy in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke
- What is being tested?
- Task Practice Physical Rehabilitation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2013to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals are eligible for this study if they have:
- experienced a stroke at least 3 months prior that has resulted in unilateral hemiparesis.
- exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
- impairment with overhead reach and wrist circumduction and fine motor dexterity.
- passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.
Who cannot join
- Individuals are not eligible for this study if they have:
- a lesion in the brainstem or cerebellum.
- another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
- pain in the affected upper extremity that would limit participation in the study intervention.
- difficulty understanding and following 3-step directions.
- difficulty sitting independently without postural support.
- an orthopedic condition or impaired corrected vision that alters the kinematics of reaching.
- are unable to travel to and remain in Charleston SC for the duration of the 4-week study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
About this study
Official title: Patient-Targeted Upper Extremity Rehabilitation After Stroke
Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.
Read the detailed description
The overwhelming majority of individuals who survive stroke have persistent upper extremity (UE) motor deficits which interfere with re-engagement in meaningful activities. While advances from neuroscience are spurring development of new rehabilitation strategies, the development of novel measurement methods has not kept pace. Currently, there is no comprehensive measurement framework to objectively quantify impairment, match a rehabilitation therapy program to a patient's impairment level, and measure specific therapy effects. Therefore there has not been a rehabilitation trial where a measurement framework is the basis for designing the treatment as well as defining the outcome. The investigators redesigned the Fugl-Meyer UE Assessment (FMA-UE) using item response theory Rasch analysis and developed a first of its kind measurement framework that locates a patient along a continuum of impairment and directs a personalized therapy program tailored to patients' specific impairments and ability levels. The purpose of this proposed research is to empirically test this framework.
The objective of this project is to empirically test the FMA-UE measurement framework.
This study hypothesizes that therapeutic task practice at the just-right challenge of difficulty will maximize post-stroke motor skill reacquisition. It is expected that "targeted task-practice", will increase UE motor ability because task goal difficulty will be matched and systematically progressed according to patients' initial and evolving levels of ability.
This is a single-blinded study with parallel arm design, stratified sampling and blocked randomization. 120 individuals with post-stroke UE hemiparesis will be enrolled; 40 participants per 3 UE impairment levels as defined by the investigators' measurement framework. Participants will engage in 12 sessions (3x/wk for 4 weeks, 2 hrs/session) of reach-to-grasp task-practice. Within each impairment level, subjects will be randomized to a treatment group; 20 to targeted task-practice and 20 to non-targeted task-practice. Targeted task-practice is personalized to patient-specific UE motor deficits with initial targets (goals) defined according to baseline measures and targets continually progressed after every 3 therapy sessions so that the goals match the patient's evolving level of ability. Non-targeted task practice is defined as a standard of care task-practice intervention intended to increase UE use but not alter specific impairments. Data analyses will include (1) ANOVA to test the effects of targeted vs. non-targeted therapy on UE motor ability, (2) multiple regression to model the relationship between therapy and movement adaptions occurring pre- to post-rehabilitation, and (3) growth mixture modeling to define responders and non-responders.
This project is significant because there is a pressing need for a comprehensive measurement framework to guide novel interventions designed to improve post-stroke UE motor function and define their effects.
- Conditions
- Stroke
- Being tested
- Task Practice Physical Rehabilitation Therapy
- Keywords
- rehabilitation, occupational therapy, upper extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Practice Physical Rehabilitation TherapyBehavioural
Also called Task Practice
Similar to stroke rehabilitation occupational therapy.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Task Practice | Experimental | Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length. Receives: Behavioral: Task Practice Physical Rehabilitation Therapy |
| Non-Targeted Task Practice | Active comparator | Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length. Receives: Behavioral: Task Practice Physical Rehabilitation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of the Upper Extremity
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is traditionally scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Instead of this traditional scoring method, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability.
Measured: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
Wolf Motor Function Test
The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function.
Measured: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
Secondary outcomes (1)
Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations
sEMG analysis is an objective method to study muscle coordination during functional arm movements. Subjects will be fitted with sensors on the skin placed over 8 arm/shoulder muscles on both arms. The sensors will detect the muscle activity of these muscles during functional reaching movements. sEMG data will be recorded with a 16-channel wireless Motion Labs EMG system and processed with custom ORBIS software.
Measured: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study start1 Mar 2013
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Michelle L. Woodbury, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819506
- Sponsor's protocol ID
- N0799-R
- Acronym
- TARG
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2013
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Woodbury ML, Velozo CA, Richards LG, Duncan PW, Studenski S, Lai SM. Dimensionality and construct validity of the Fugl-Meyer Assessment of the upper extremity. Arch Phys Med Rehabil. 2007 Jun;88(6):715-23. doi: 10.1016/j.apmr.2007.02.036.
PubMed 17532892Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.
PubMed 22234665
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Targeted Upper Extremity Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT01819506
- Acronym / sponsor ID
- TARG / N0799-R
- Conditions
- Stroke
- Keywords
- rehabilitation, occupational therapy, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Medical University of South Carolina
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.
Detailed description
The overwhelming majority of individuals who survive stroke have persistent upper extremity (UE) motor deficits which interfere with re-engagement in meaningful activities. While advances from neuroscience are spurring development of new rehabilitation strategies, the development of novel measurement methods has not kept pace. Currently, there is no comprehensive measurement framework to objectively quantify impairment, match a rehabilitation therapy program to a patient's impairment level, and measure specific therapy effects. Therefore there has not been a rehabilitation trial where a measurement framework is the basis for designing the treatment as well as defining the outcome. The investigators redesigned the Fugl-Meyer UE Assessment (FMA-UE) using item response theory Rasch analysis and developed a first of its kind measurement framework that locates a patient along a continuum of impairment and directs a personalized therapy program tailored to patients' specific impairments and ability levels. The purpose of this proposed research is to empirically test this framework.
The objective of this project is to empirically test the FMA-UE measurement framework.
This study hypothesizes that therapeutic task practice at the just-right challenge of difficulty will maximize post-stroke motor skill reacquisition. It is expected that "targeted task-practice", will increase UE motor ability because task goal difficulty will be matched and systematically progressed according to patients' initial and evolving levels of ability.
This is a single-blinded study with parallel arm design, stratified sampling and blocked randomization. 120 individuals with post-stroke UE hemiparesis will be enrolled; 40 participants per 3 UE impairment levels as defined by the investigators' measurement framework. Participants will engage in 12 sessions (3x/wk for 4 weeks, 2 hrs/session) of reach-to-grasp task-practice. Within each impairment level, subjects will be randomized to a treatment group; 20 to targeted task-practice and 20 to non-targeted task-practice. Targeted task-practice is personalized to patient-specific UE motor deficits with initial targets (goals) defined according to baseline measures and targets continually progressed after every 3 therapy sessions so that the goals match the patient's evolving level of ability. Non-targeted task practice is defined as a standard of care task-practice intervention intended to increase UE use but not alter specific impairments. Data analyses will include (1) ANOVA to test the effects of targeted vs. non-targeted therapy on UE motor ability, (2) multiple regression to model the relationship between therapy and movement adaptions occurring pre- to post-rehabilitation, and (3) growth mixture modeling to define responders and non-responders.
This project is significant because there is a pressing need for a comprehensive measurement framework to guide novel interventions designed to improve post-stroke UE motor function and define their effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Task Practice | Experimental | Behavioral: Task Practice Physical Rehabilitation TherapyTargeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length. |
| Non-Targeted Task Practice | Active comparator | Behavioral: Task Practice Physical Rehabilitation TherapyNon-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- experienced a stroke at least 3 months prior that has resulted in unilateral hemiparesis.
- exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
- impairment with overhead reach and wrist circumduction and fine motor dexterity.
- passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.
Key exclusion criteria (8 listed)
- a lesion in the brainstem or cerebellum.
- another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
- pain in the affected upper extremity that would limit participation in the study intervention.
- difficulty understanding and following 3-step directions.
- difficulty sitting independently without postural support.
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 |
|---|---|---|
| Task Practice Physical Rehabilitation TherapyAlso: Task PracticeSimilar to stroke rehabilitation occupational therapy. | Behavioural | Non-Targeted Task Practice, Targeted Task Practice |
Primary outcome
Fugl-Meyer Assessment of the Upper Extremity
Time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is traditionally scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Instead of this traditional scoring method, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability.
Wolf Motor Function Test
Time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function.
1 secondary outcome
Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations
Time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17532892Woodbury ML, Velozo CA, Richards LG, Duncan PW, Studenski S, Lai SM. Dimensionality and construct validity of the Fugl-Meyer Assessment of the upper extremity. Arch Phys Med Rehabil. 2007 Jun;88(6):715-23. doi: 10.1016/j.apmr.2007.02.036.
- Background: PubMed 22234665Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.
- Individual participant dataSharing planned: Undecided
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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.
Michelle L. Woodbury, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Practice Physical Rehabilitation Therapy in people with Stroke, run by VA Office of Research and Development 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 5 inclusion and 8 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 8 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fugl-Meyer Assessment of the Upper Extremity (time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 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 NCT01819506, which also lists 2 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 8 Aug 2019.