Cerebrovascular AccidentNCT00125658
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
A study testing Experimental in people with Cerebrovascular Accident, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cerebrovascular accident
- Single event
- Unilateral hemiplegia
- Between 6 months and 18 months post-event
- Impairment of upper-extremity function
- Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist
- At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers
- Cognitive ability to follow 3-step commands
Who cannot join
- Unstable or uncontrolled blood pressure
- Uncontrolled seizures
- Flaccid hemiplegia
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
Read the detailed description
This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. Re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.
- Conditions
- Cerebrovascular Accident
- Being tested
- Control, Experimental
- Keywords
- biomechanics, Cerebrovascular Accident, electromyography, muscular weakness, recovery of function, reflex variability stroke, upper-extremity kinematics
- Medical subject headings
- Stroke, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Order A
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
ExperimentalOther
Also called Order B
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) Receives: Other: Control |
| Experimental | Experimental | POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trunk Displacement
Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Change in Shoulder Flexion
joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Change in Elbow Extension Range of Motion
joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Upper-extremity Fugl-Meyer Motor Assessment
The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Secondary outcomes (3)
Movement Speed
peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Movement Accuracy (Reach Path Ratio, RPR)
Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Movement Smoothness
Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or "jerky" movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline.
Measured: baseline, 10 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionSep 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carolynn Patten, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125658
- Sponsor's protocol ID
- B3964-R
- Status last verified
- Jun 2017
- First submitted
- 28 Jul 2005
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Corti M, McGuirk TE, Wu SS, Patten C. Differential effects of power training versus functional task practice on compensation and restoration of arm function after stroke. Neurorehabil Neural Repair. 2012 Sep;26(7):842-54. doi: 10.1177/1545968311433426. Epub 2012 Feb 22.
PubMed 22357633Phadke CP, Robertson CT, Condliffe EG, Patten C. Upper-extremity H-reflex measurement post-stroke: reliability and inter-limb differences. Clin Neurophysiol. 2012 Aug;123(8):1606-15. doi: 10.1016/j.clinph.2011.12.012. Epub 2012 Jan 23.
PubMed 22277759Phadke CP, Robertson CT, Patten C. Upper-extremity spinal reflex inhibition is reproducible and strongly related to grip force poststroke. Int J Neurosci. 2015 Jun;125(6):441-8. doi: 10.3109/00207454.2014.946990. Epub 2014 Sep 3.
PubMed 25135282
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
- ClinicalTrials.gov ID
- NCT00125658
- Acronym / sponsor ID
- B3964-R
- Conditions
- Cerebrovascular Accident
- Keywords
- biomechanics, Cerebrovascular Accident, electromyography, muscular weakness, recovery of function, reflex variability stroke, upper-extremity kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Posted 23 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
Detailed description
This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. Re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlFTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) |
| Experimental | Experimental | Other: ExperimentalPOWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of cerebrovascular accident
- Single event
- Unilateral hemiplegia
- Between 6 months and 18 months post-event
- Impairment of upper-extremity function
Key exclusion criteria (4 listed)
- Unstable or uncontrolled blood pressure
- Uncontrolled seizures
- Flaccid hemiplegia
- Severe cognitive impairment
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 |
|---|---|---|
| ControlAlso: Order AFollowing an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program. | Other | Control |
| ExperimentalAlso: Order BFollowing an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program. | Other | Experimental |
Primary outcome
Change in Trunk Displacement
Time frame: baseline, 10 weeks, 20 weeks
Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.
Change in Shoulder Flexion
Time frame: baseline, 10 weeks, 20 weeks
joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.
Change in Elbow Extension Range of Motion
Time frame: baseline, 10 weeks, 20 weeks
joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.
Upper-extremity Fugl-Meyer Motor Assessment
Time frame: baseline, 10 weeks, 20 weeks
The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.
3 secondary outcomes
Movement Speed
Time frame: baseline, 10 weeks, 20 weeks
Movement Accuracy (Reach Path Ratio, RPR)
Time frame: baseline, 10 weeks, 20 weeks
Movement Smoothness
Time frame: baseline, 10 weeks, 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22357633Corti M, McGuirk TE, Wu SS, Patten C. Differential effects of power training versus functional task practice on compensation and restoration of arm function after stroke. Neurorehabil Neural Repair. 2012 Sep;26(7):842-54. doi: 10.1177/1545968311433426. Epub 2012 Feb 22.
- Results publication: PubMed 22277759Phadke CP, Robertson CT, Condliffe EG, Patten C. Upper-extremity H-reflex measurement post-stroke: reliability and inter-limb differences. Clin Neurophysiol. 2012 Aug;123(8):1606-15. doi: 10.1016/j.clinph.2011.12.012. Epub 2012 Jan 23.
- Results publication: PubMed 25135282Phadke CP, Robertson CT, Patten C. Upper-extremity spinal reflex inhibition is reproducible and strongly related to grip force poststroke. Int J Neurosci. 2015 Jun;125(6):441-8. doi: 10.3109/00207454.2014.946990. Epub 2014 Sep 3.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebrovascular Accident
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Carolynn Patten, PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Cerebrovascular Accident, 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 8 inclusion and 4 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 23 Jun 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 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 23 Jun 2017). 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?
Change in Trunk Displacement (time frame: baseline, 10 weeks, 20 weeks). The study lists 4 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 NCT00125658, which also lists 3 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 23 Jun 2017.