Clinical trial NCT03020576: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: New York University
First posted: 2017-01-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
timeFrame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
Secondary outcomes:
measure: Change in Range of Motion Measures
timeFrame: Through study completion, an average of 8 weeks
measure: Change in Hand and Pinch Strength
timeFrame: Through study completion, an average of 8 weeks
measure: Change in Motor Activity Log Amount
timeFrame: Through study completion (taken at baseline and at 8-week study completion)
measure: Change in Mobility and Activities of Daily Living
timeFrame: Through study completion (taken at baseline and at 8 week study completion)
measure: Change in Hand Dexterity
timeFrame: Through study completion, an average of 8 weeks
measure: Change in Spasticity Measures
timeFrame: Through study completion, an average of 8 weeks
measure: Change in Motor Activity Log How Well
timeFrame: Through study completion (taken at baseline and on 8 week study completion)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
Study officials:
affiliation: Columbia University
name: Joel Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innsbruck Medical University
name: Raimund Helbok, MD
role: PRINCIPAL_INVESTIGATOR
References: