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NCT Number: NCT03020576

Robotic and Conventional Hand Therapy After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innsbruck Medical University, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amadeo Hand Robot Device

Device

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

Conventional Therapy

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.

Primary outcomes

  1. Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer

    Time frame: 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 outcomes

  1. Change in Range of Motion Measures

    Time frame: 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)

  2. Change in Hand and Pinch Strength

    Time frame: Through study completion, an average of 8 weeks

    quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms

  3. Change in Motor Activity Log Amount

    Time frame: 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.

  4. Change in Mobility and Activities of Daily Living

    Time frame: 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.

  5. Change in Hand Dexterity

    Time frame: 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.

  6. Change in Spasticity Measures

    Time frame: 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.

  7. Change in Motor Activity Log How Well

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Medical University Innsbruck
  • New York University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Jan 13, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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