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.
- Conventional therapy Other
Intervention Desc: 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. ARM 1: Kind: Experimental Label: Conventional Therapy Description: Participants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand.
- Amadeo Hand Robot Device Device
Intervention Desc: This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers. ARM 1: Kind: Experimental Label: Robotic Therapy Description: Participants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Impairment based arm measures - Upper Extremity portion of the Fugl Meyer||Through study completion, an average of 8 weeks|
|Secondary||Range of motion measures||Through study completion, an average of 8 weeks|
|Secondary||Hand and Pinch Strength||Through study completion, an average of 8 weeks|
|Secondary||Motor Activity Log||Through study completion, an average of 8 weeks|
|Secondary||Mobility and Activities of Daily Living||Through study completion, an average of 8 weeks|
|Secondary||Hand Dexterity Testing||Through study completion, an average of 8 weeks|
|Secondary||Spasticity Measures||Through study completion, an average of 8 weeks|