Robotic and Conventional Hand Therapy After Stroke

Stroke Clinical Trial

Official title:

Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020576
• Other study ID #: AAAI0093
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 23, 2018
• Start date: April 2011
• Est. completion date: March 2016

Study information

• Verified date: January 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2016
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Austria	Innsbruck Medical University	Innsbruck
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Medical University Innsbruck, New York University

Countries where clinical trial is conducted

United States,  Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
Secondary	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)	Through study completion, an average of 8 weeks
Secondary	Change in Hand and Pinch Strength	quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms	Through study completion, an average of 8 weeks
Secondary	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.	Through study completion (taken at baseline and at 8-week study completion)
Secondary	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.	Through study completion (taken at baseline and at 8 week study completion)
Secondary	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.	Through study completion, an average of 8 weeks
Secondary	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.	Through study completion, an average of 8 weeks
Secondary	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.	Through study completion (taken at baseline and on 8 week study completion)