Spinal Cord InjuryNCT00833105
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
A study testing AMES treatment in people with Spinal Cord Injury and Tetraplegia, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia, Paresis
- What is being tested?
- AMES treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Jan 2012
- 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 SCI with tetraplegia.
- Male or female.
- 18-65 yrs old.
- At least 1 yr post-SCI.
- Tolerate sitting upright at for at least one hour.
- Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested.
- Motor grade >1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested.
- Cognitively and behaviorally capable of complying with the regimen.
Who cannot join
- Fracture of the treated limb resulting in loss of range of motion
- Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study)
- DVT of the treated extremity
- Peripheral nerve injury of the treated extremity
- Osteo- or rheumatoid-arthritis limiting range of motion
- Contractures equal to or greater than 50% of the normal ROM
Show all 13Show fewer
- Skin condition not tolerant of device
- Progressive neurodegenerative disorder
- Botox treatment of the treated extremity in the prior 5 month
- Chronic ITB therapy
- Uncontrolled seizure disorder
- Uncontrolled high blood pressure/angina
- Pain in affected limb or exercise intolerance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shepherd Center
Atlanta, Georgia, 30309
Oregon Health and Science University
Portland, Oregon, 97006
About this study
Official title: Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)
The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.
The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).
Read the detailed description
Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.
In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.
- Conditions
- Spinal Cord Injury, Tetraplegia, Paresis, Plegia
- Being tested
- AMES treatment
- Keywords
- Incomplete Spinal Cord Injury, Rehabilitation, Upper Extremity, AMES device, Incomplete SCI, Quadriplegia
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Paresis, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMES treatmentDevice
The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.
| Study group | Role | What they receive |
|---|---|---|
| AMES treatment | Experimental | The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device. Receives: Device: AMES treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasp Release Test
The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Secondary outcomes (12)
ASIA Motor Key Muscles
ISNCSCI Assessment of motor function (upper limb only). Scores on a scale ranging from 0 (i.e., total paralysis) - 5 (i.e., full range of motion) for each of 5 upper limb muscle groups. Total score represents the overall level of the upper limb impairment and represents the sum of the 5 scores from the 5 upper limb muscle groups. Accordingly, the total score has a range of 0-25, with 0 representing a completely paralyzed upper limb and 25 representing a normally functioning upper limb.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch
Measures the subject's sensory perception, with eyes closed, of a light touch by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick
Measures the subject's sensory perception, with eyes closed, of a light prick of a safety pin produced by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Van Lieshout Hand Function Test for Tetraplegia- Short Version
Measures the functional movement in the upper limb of people with cervical spinal cord injury. The short version of this test includes a total of 10 different functional tasks to be performed by the subject with the upper limb. For example, one task is to reach and pick up a filled Coke bottle, set it down, and then replace it in its original position. Each task is scored on a scale of 0-5, 0 representing inability to perform the task and 5 representing normal movement. A single, total score is calculated as the sum of the scores on the 10 tasks, and therefore, has an overall range of 0-50, with higher scores representing better performance.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Modified Ashworth Scale
Measurement of joint stiffness (tone/spasticity). Score is based on sum of MAS value for 4 muscle groups: (1) Wrist/finger flexors, (2) Wrist/finger extensors, (3) elbow flexors, and (4) elbow extensors. Each muscle group and direction is score on a scale of 0 (no increase in muscle tone) to 5 (rigid), with a score of 2 used instead of 1+. A single overall score representing the sum of all 4 muscle groups and directions is used and has a range of 0-20 with higher scores representing more severe impairment.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Capabilities of Upper Extremity Instrument
Subjective questionnaire of participants' self-perceptions of upper limb function that contains 17 questions relating to the use of the right upper limb, the same 17 relating to the use of the lower upper limb, plus two additional questions relating to bimanual function. Responses to each item of the questionnaire has a range of 1 (i.e., "totally limited") to 7 (i.e., "not at all limited"). A total cumulative score used for the study is based on the sum of the responses to all 34 questions (i.e., 16 right arm, 16 left arm, 2 both arms), and therefore has a cumulative score range of 32 - 224, with higher scores indicating more function.
Measured: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Strength Test - Thumb/Finger Extension
Maximum strength of thumb-and-fingers in extension.
Pre-training score is average of a total of 3 scores, including 1 score from each of the first 3 days of training. Post-training score is average of a total of 3 scores, including 1 score from each of the last 3 days of training.
Measured: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Strength Test - Thumb/Fingers Flexion
Maximum strength of Thumb/fingers in Flexion
Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.
Measured: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Strength Test - Wrist Extension
Maximum wrist strength in extension
Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.
Measured: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Strength Test - Wrist Flexion
Maximum strength in flexion direction
Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.
Measured: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Active Motion Test - Fingers/Thumb
Tracking task for the thumb and finger, i.e., opening and closing the hand. The participant tracks a target box on a video screen by actively moving the thumb and fingers, first in the opening direction, then closing, and finally opeining again. The participant's thumb-and-finger position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The "Pre-training Score" is the average score obtained during the first 3 days of training, and the Post-training Score" is average score obtained during the last 3 days of training.
Measured: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Active Motion Test - Wrist
Tracking task for the wrist, i.e., flexing (i.e., pull with the front of the hand) and extending (i.e., pushing with the back of the hand). The participant tracks a target box on a video screen by actively moving the hand at the wrist, first in the extension direction, then flexion, and finally extension again. The participant's wrist position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The "Pre-training Score" is the average score obtained during the first 3 days of training, and the Post-training Score" is average score obtained during the last 3 days of training.
Measured: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionJan 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA
- Responsible party
- Principal investigator, Paul J. Cordo, Oregon Health and Science University
- Investigators
- Paul J. Cordo, Ph.D, Principal investigator, Oregon Health and Science UniversityDeborah Backus, PhD, PT, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833105
- Sponsor's protocol ID
- 4649
- Status last verified
- Apr 2019
- First submitted
- 29 Jan 2009
- Last updated
- 1 May 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 18645190
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT00833105
- Acronym / sponsor ID
- 4649
- Conditions
- Spinal Cord Injury, Tetraplegia, Paresis, Plegia
- Keywords
- Incomplete Spinal Cord Injury, Rehabilitation, Upper Extremity, AMES device, Incomplete SCI, Quadriplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.
The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).
Detailed description
Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.
In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMES treatment | Experimental | Device: AMES treatmentThe subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Traumatic SCI with tetraplegia.
- Male or female.
- 18-65 yrs old.
- At least 1 yr post-SCI.
- Tolerate sitting upright at for at least one hour.
Key exclusion criteria (13 listed)
- Fracture of the treated limb resulting in loss of range of motion
- Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study)
- DVT of the treated extremity
- Peripheral nerve injury of the treated extremity
- Osteo- or rheumatoid-arthritis limiting range of motion
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 treatmentThe AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device. | Device | AMES treatment |
Primary outcome
Grasp Release Test
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.
12 secondary outcomes
ASIA Motor Key Muscles
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Van Lieshout Hand Function Test for Tetraplegia- Short Version
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Modified Ashworth Scale
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Capabilities of Upper Extremity Instrument
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Strength Test - Thumb/Finger Extension
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Strength Test - Thumb/Fingers Flexion
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Strength Test - Wrist Extension
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Strength Test - Wrist Flexion
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Active Motion Test - Fingers/Thumb
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Active Motion Test - Wrist
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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 principal investigator
Oregon Health and Science University
Deborah Backus, PhD, PT principal investigator
Shepherd Center, Atlanta GA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMES treatment in people with Spinal Cord Injury and Tetraplegia, run by Oregon Health and Science University at 2 sites 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 13 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 8 Apr 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?
Grasp Release Test (time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training). 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 NCT00833105, 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 1 May 2019.