Robotic and Conventional Hand Therapy After Stroke

NCT ID: NCT03020576

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Conventional Therapy

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.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: OTHER

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.

Robotic Therapy

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.

Group Type: EXPERIMENTAL

Amadeo Hand Robot Device

Intervention Type: DEVICE

This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.

Interventions

Amadeo Hand Robot Device

This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.

Intervention Type: DEVICE

Conventional Therapy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Joel Stein

Department of Rehabilitation and Regenerative Medicine Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Raimund Helbok, MD

Role: PRINCIPAL_INVESTIGATOR

Innsbruck Medical University

Locations

Columbia University Medical Center

New York, New York, United States

Innsbruck Medical University

Innsbruck, , Austria

Countries

United States; Austria

Other Identifiers

AAAI0093

Identifier Type: -

Identifier Source: org_study_id