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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT00833105
Study groupRoleWhat they receive
AMES treatmentExperimentalThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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.

  1. First posted30 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2011
  4. Study completionJan 2012

Resources

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)
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
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

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.

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