Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injury, Tetraplegia, Paresis, Plegia

Intervention / Treatment
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* Device: AMES treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMES treatment<br>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. | Device: AMES treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMES device, Incomplete Spinal Cord Injury, Rehabilitation, Upper Extremity, Incomplete SCI, Quadriplegia