Robotic and Conventional Hand Therapy After Stroke

Columbia University

Status: Completed

Conditions: Stroke

Treatments: Device: Amadeo Hand Robot Device; Other: Conventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03020576

AAAI0093

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of stroke (>3 months from time of ictus)
• paresis or plegia of the upper extremity.

Exclusion criteria

• severe spasticity (defined on the Ashworth Scale with a score of 4-5)
• severe pain despite conventional pain therapy of the paretic upper extremity
• swelling, infection, fracture or ulcers of the paretic extremity
• arthritis of the hand joints
• pregnant
• botulinum toxin- therapy to the upper extremity within 3 months prior to study entry
• severe contractions

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Conventional Therapy

Active Comparator group

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.

Treatment:

Other: Conventional Therapy

Robotic Therapy

Experimental group

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.

Treatment:

Device: Amadeo Hand Robot Device