Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use. Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function. Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies. A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
31
This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.
This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.
Columbia University Medical Center
New York, New York, United States
Innsbruck Medical University
Innsbruck, Austria
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.
Time frame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
Change in Range of Motion Measures
quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
Time frame: Through study completion, an average of 8 weeks
Change in Hand and Pinch Strength
quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Time frame: Through study completion, an average of 8 weeks
Change in Motor Activity Log Amount
quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
Time frame: Through study completion (taken at baseline and at 8-week study completion)
Change in Mobility and Activities of Daily Living
The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.
Time frame: Through study completion (taken at baseline and at 8 week study completion)
Change in Hand Dexterity
The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.
Time frame: Through study completion, an average of 8 weeks
Change in Spasticity Measures
The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.
Time frame: Through study completion, an average of 8 weeks
Change in Motor Activity Log How Well
quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.
Time frame: Through study completion (taken at baseline and on 8 week study completion)
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