Robotic and Conventional Hand Therapy After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Amadeo Hand Robot Device; Other: Conventional Therapy

• Registration Number: NCT03020576
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-03
• Study Completion: 2016-03
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Results First Submitted: 2017-01-17
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Results First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Therapy	Amadeo Hand Robot Device	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.
Conventional Therapy	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.

Primary Outcome Measures

Name	Time	Method
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer	Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hand and Pinch Strength	Through study completion, an average of 8 weeks	quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Change in Range of Motion Measures	Through study completion, an average of 8 weeks	quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
Change in Hand Dexterity	Through study completion, an average of 8 weeks	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.
Change in Motor Activity Log Amount	Through study completion (taken at baseline and at 8-week study completion)	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.
Change in Mobility and Activities of Daily Living	Through study completion (taken at baseline and at 8 week study completion)	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.
Change in Spasticity Measures	Through study completion, an average of 8 weeks	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.
Change in Motor Activity Log How Well	Through study completion (taken at baseline and on 8 week study completion)	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.

Trial Locations

Locations (2)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Innsbruck Medical University; 🇦🇹 Innsbruck, Austria