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Robotic and Conventional Hand Therapy After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Amadeo Hand Robot Device
Conventional Therapy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Columbia University Medical Center
  • Innsbruck Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Therapy

Robotic Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Change in Hand and Pinch Strength
quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
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.
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.
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.
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.
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.

Full Information

First Posted
January 10, 2017
Last Updated
January 23, 2018
Sponsor
Columbia University
Collaborators
Medical University Innsbruck, New York University
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1. Study Identification

Unique Protocol Identification Number
NCT03020576
Brief Title
Robotic and Conventional Hand Therapy After Stroke
Official Title
Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Medical University Innsbruck, New York University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Robotic Therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Amadeo Hand Robot Device
Intervention Description
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
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
Description
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.
Time Frame
Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
Secondary Outcome Measure Information:
Title
Change in Range of Motion Measures
Description
quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
Time Frame
Through study completion, an average of 8 weeks
Title
Change in Hand and Pinch Strength
Description
quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Time Frame
Through study completion, an average of 8 weeks
Title
Change in Motor Activity Log Amount
Description
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.
Time Frame
Through study completion (taken at baseline and at 8-week study completion)
Title
Change in Mobility and Activities of Daily Living
Description
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.
Time Frame
Through study completion (taken at baseline and at 8 week study completion)
Title
Change in Hand Dexterity
Description
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.
Time Frame
Through study completion, an average of 8 weeks
Title
Change in Spasticity Measures
Description
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.
Time Frame
Through study completion, an average of 8 weeks
Title
Change in Motor Activity Log How Well
Description
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.
Time Frame
Through study completion (taken at baseline and on 8 week study completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Stein, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raimund Helbok, MD
Organizational Affiliation
Innsbruck Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Innsbruck Medical University
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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Robotic and Conventional Hand Therapy After Stroke

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