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

Active, not recruiting

Phase 1/2 Results N/A

Trial Description

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 20 subjects, more than 1 year post injury, will be 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

Interventions

  • Manipulandum Device
  • Tendon vibrator Device
    Intervention Desc: A motor that produces mechanical impulses to be transmitted either directly to the muscle belly or indirectly to the muscle's tendon. These impulses stimulate proprioceptive receptors in the muscle.
  • Manipulandum table Device
    Intervention Desc: A table (device) with rotational actuators for the elbow, wrist and fingers. During experimentation, these joints may be moved, or they may be held in a fixed position while the subject exerts volitional torque on the device, or they may be released for the subject to make free movements.
  • AMES treatment Device
    Other Names: AMES treatment
    Intervention Desc: The AMES device rotates the fingers-thumb and the wrist over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the hand. 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.
    ARM 1: Kind: Experimental
    Label: AMES treatment
    Description: 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.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment
  • Observation: Cohort
  • Perspective: Prospective

Outcomes

Type Measure Time Frame Safety Issue
Primary Afferent nerve-firing patterns
Primary task performance levels
Primary Grasp Release Test After enrollment and prior to the start of treatment No
Secondary ASIA grade for motor score and sensory score of the upper extremity being treated After enrollment and prior to the start of the treatments No
Secondary Van Lieshout Test - Short Version After enrollment and prior to the start of treatment No
Secondary Modified Ashworth Scale After enrollment and prior to the start of treatments No
Secondary Capabilities of Upper Extremities After enrollment and prior to the start of treatment No
Secondary Self-Care Activities Supplement After enrollment and prior to the start of treatments No
Secondary Joint Position Test Prior to each treatment session No
Secondary Strength Test Prior to each treatment session No
Secondary Joint Stiffness Test Prior to each treatment session No
Secondary 2 Point Discrimination After enrollment and prior to the start of treatment No
Secondary Capabilities of Upper Extremity 3 months following the end of the treatments No

Sponsors