Spinal Cord InjuryNCT01974635
Proprioception Testing in Persons With Sensorimotor Impairment
A study testing AMES Therapy in people with Spinal Cord Injury and Stroke, run by Oregon Health and Science University at 1 site in United States.
Trial summary
In this study, an FDA-cleared device and type of treatment called "AMES," which stands for Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Stroke, Acquired Brain Injury
- What is being tested?
- AMES Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic incomplete SCI, stroke or acquired brain injured ABI subjects.
- Able to tolerate sitting upright at for at least 1 hour.
- Significant, but not complete, motor deficit in the hand and wrist, as determined by the Study Physician performing the screening.
- Significant, but not complete somatosensory deficit in the hand and wrist as determined by the Study Physician performing the screening.
- Cognitively and behaviorally capable of complying with the regimen.
Who cannot join
- Fracture of the treated limb resulting in loss of range of motion.
- Progressive neurodegenerative disorder.
- DVT of the treated extremity.
- Uncontrolled seizure disorder.
- Uncontrolled high blood pressure/angina.
- Osteo- or rheumatoid arthritis limiting range of motion
Show all 12Show fewer
- Contractures equal to or greater than 50% of the normal ROM.
- Chronic ITB therapy.
- Peripheral nerve injury of the treated extremity.
- Pain in affected limb or exercise intolerance.
- Participation in another therapy or activity-based program.
- Skin condition not tolerant of device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
In this study, an FDA-cleared device and type of treatment called "AMES," which stands for Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through treatment. We hypothesize that measureable improvement in the sensation of the upper limb will precede improvement in functional movement.
Read the detailed description
The AMES device performs tests of sensorimotor impairment as well as delivering therapy. In this study, we are testing 2 additional diagnostic tests (i.e., Joint Position Test and "Frisbee" Test), both of proprioception, in order to determine which of the two is the best test of proprioception. Our hypotheses are: (1) both sensation and movement recover with AMES treatment, (2) sensory recovery precedes that of movement, (3) robotic delivery of the Joint Position Test produces more reliable test results than does manual delivery of this test, and (4) the Frisbee Test results will parallel those of the Joint Position Test.
- Conditions
- Spinal Cord Injury, Stroke, Acquired Brain Injury
- Being tested
- AMES Therapy
- Keywords
- Spinal Cord Injury, Robotic therapy, Rehabilitation, Sensation, Movement, Proprioception, Stroke, Acquired Brain Injury
- Medical subject headings
- Spinal Cord Injuries, Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMES TherapyDevice
During the therapy session, the AMES device rotates the hand into flexion and extension, while the patient assists with this motion, as possible. At the same time, the AMES device provides sensory stimulation by vibrating the tendons of muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so that the sensory stimulation remains functionally related to the movement. The subject will receive visual bio-feedback of their contribution to the motor movement.
| Study group | Role | What they receive |
|---|---|---|
| AMES Therapy and Diagnostic | Experimental | During treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week. Receives: Device: AMES Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Test - AMES Device
Testing proprioceptive sensation, the subject, with eyes closed, attempts to identify verbally the direction of motion (i.e., flexion or extension) as the AMES device randomly moves the subject's thumb and fingers, or the whole hand, into flexion and extension.
Measured: Immediately after each treatment on the AMES Device
Secondary outcomes (1)
Frisbee Test - Device
Testing proprioceptive sensation, the AMES device moves the subject's wrist through a 30 degree range, at variable speeds, as the subject attempts to identify when their wrist reaches a particular target, either by opening contact between the thumb and index finger (if possible) or blinking the eyes. The subject receives feedback about the accuracy of the testing.
Measured: After each treatment on the AMES device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Device used for eye-blinks did not work as performed.
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 Spinal Cord InjuryStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul J. Cordo, Oregon Health and Science University
- Investigators
- Paul J Cordo, Ph.D, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974635
- Sponsor's protocol ID
- 00009635
- Status last verified
- Jun 2019
- First submitted
- 21 Oct 2013
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.
PubMed 18645190Backus D, Cordo P, Gillott A, Kandilakis C, Mori M, Raslan AM. Assisted movement with proprioceptive stimulation reduces impairment and restores function in incomplete spinal cord injury. Arch Phys Med Rehabil. 2014 Aug;95(8):1447-53. doi: 10.1016/j.apmr.2014.03.011. Epub 2014 Mar 28.
PubMed 24685386Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023.
PubMed 24232364
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioception Testing in Persons With Sensorimotor Impairment
- ClinicalTrials.gov ID
- NCT01974635
- Acronym / sponsor ID
- 00009635
- Conditions
- Spinal Cord Injury, Stroke, Acquired Brain Injury
- Keywords
- Spinal Cord Injury, Robotic therapy, Rehabilitation, Sensation, Movement, Proprioception, Stroke, Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device used for eye-blinks did not work as performed.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, an FDA-cleared device and type of treatment called "AMES," which stands for Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through treatment. We hypothesize that measureable improvement in the sensation of the upper limb will precede improvement in functional movement.
Detailed description
The AMES device performs tests of sensorimotor impairment as well as delivering therapy. In this study, we are testing 2 additional diagnostic tests (i.e., Joint Position Test and "Frisbee" Test), both of proprioception, in order to determine which of the two is the best test of proprioception. Our hypotheses are: (1) both sensation and movement recover with AMES treatment, (2) sensory recovery precedes that of movement, (3) robotic delivery of the Joint Position Test produces more reliable test results than does manual delivery of this test, and (4) the Frisbee Test results will parallel those of the Joint Position Test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMES Therapy and Diagnostic | Experimental | Device: AMES TherapyDuring treatment, the AMES device rotates the hand, into flexion and extension, while the patient assists with this motion,and while the lengthening muscle(s) are vibrated mechanically. At the end of the treatment, several diagnostic tests are performed to measure the participant's level of proprioceptive perception. This study provides for 25 AMES treatments and diagnostic tests over 8-13 weeks, at a rate of 2-3 sessions per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Traumatic incomplete SCI, stroke or acquired brain injured ABI subjects.
- Able to tolerate sitting upright at for at least 1 hour.
- Significant, but not complete, motor deficit in the hand and wrist, as determined by the Study Physician performing the screening.
- Significant, but not complete somatosensory deficit in the hand and wrist as determined by the Study Physician performing the screening.
- Cognitively and behaviorally capable of complying with the regimen.
Key exclusion criteria (12 listed)
- Fracture of the treated limb resulting in loss of range of motion.
- Progressive neurodegenerative disorder.
- DVT of the treated extremity.
- Uncontrolled seizure disorder.
- Uncontrolled high blood pressure/angina.
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 |
|---|---|---|
| AMES TherapyDuring the therapy session, the AMES device rotates the hand into flexion and extension, while the patient assists with this motion, as possible. At the same time, the AMES device provides sensory stimulation by vibrating the tendons of muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so that the sensory stimulation remains functionally related to the movement. The subject will receive visual bio-feedback of their contribution to the motor movement. | Device | AMES Therapy and Diagnostic |
Primary outcome
Joint Position Test - AMES Device
Time frame: Immediately after each treatment on the AMES Device
Testing proprioceptive sensation, the subject, with eyes closed, attempts to identify verbally the direction of motion (i.e., flexion or extension) as the AMES device randomly moves the subject's thumb and fingers, or the whole hand, into flexion and extension.
1 secondary outcome
Frisbee Test - Device
Time frame: After each treatment on the AMES device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18645190Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.
- Background: PubMed 24685386Backus D, Cordo P, Gillott A, Kandilakis C, Mori M, Raslan AM. Assisted movement with proprioceptive stimulation reduces impairment and restores function in incomplete spinal cord injury. Arch Phys Med Rehabil. 2014 Aug;95(8):1447-53. doi: 10.1016/j.apmr.2014.03.011. Epub 2014 Mar 28.
- Background: PubMed 24232364Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023.
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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.
Paul J Cordo, Ph.D study director
Oregon Health and Science 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 AMES Therapy in people with Spinal Cord Injury and Stroke, run by Oregon Health and Science 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Jun 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 13 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?
Joint Position Test - AMES Device (time frame: Immediately after each treatment on the AMES Device). 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 NCT01974635, 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 13 Jun 2019.