N/A
N=13
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
Spinal Cord Injury · Tetraplegia · Paresis · Plegia
Bottom Line
View on ClinicalTrials.gov: NCT00833105 ↗Enrolled (actual)
13
Serious AEs
15.4%
Results posted
Apr 2019
Primary outcome: Primary: Grasp Release Test — 58.5; 72.0; 77.5 Objects moved — p=<0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AMES treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Grasp Release Test |
58.5; 72.0; 77.5 | <0.025 sig |
| SECONDARY ASIA Motor Key Muscles |
15.3; 14.6; 16.1 | 0.299 |
| SECONDARY ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch |
14.1; 13.8; 14.5 | 0.459 |
| SECONDARY ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick |
10.5; 11.3; 11.1 | 0.343 |
| SECONDARY Van Lieshout Hand Function Test for Tetraplegia- Short Version |
27.2; 27.3; 27.4 | 0.951 |
| SECONDARY Modified Ashworth Scale |
5.3; 4.4; 4.2 | 0.371 |
| SECONDARY Capabilities of Upper Extremity Instrument |
58.2; 64.1; 63.8 | 0.164 |
| SECONDARY Strength Test - Thumb/Finger Extension |
0.43; 0.65 | <0.01 sig |
| SECONDARY Strength Test - Thumb/Fingers Flexion |
2.10; 2.87 | <0.05 sig |
| SECONDARY Strength Test - Wrist Extension |
2.27; 3.51 | <0.0001 sig |
| SECONDARY Strength Test - Wrist Flexion |
5.41; 7.95 | <0.005 sig |
| SECONDARY Active Motion Test - Fingers/Thumb |
6.95; 10.63 | <0.001 sig |
| SECONDARY Active Motion Test - Wrist |
18.50; 26.62 | <0.001 sig |
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.
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00833105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.