Stroke
Conditions
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.
Interventions
DEVICEAmadeo 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.
OTHERConventional 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.
Sponsors
Medical University Innsbruck
New York University
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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. |
Countries
Austria, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Group The purpose of this group is to provide training that is matched to the robotic group in duration and intensity. Participants randomized to this group receive therapy to the affected/paretic upper limb. This therapy is aimed at improving range of motion, strength and functionality. Similar to the robotic group, treatment sessions occurred three times weekly for eight weeks, and sessions were 60 minutes in duration. | 14 |
| Robotic Group The purpose of this group was to provide robotic based training using the Amadeo Hand Robotic Device (Tyromotion, GmbH, Graz, Austria) as a tool to improve range of motion, strength and functionality of the hand in a population of individuals post stroke. Treatment sessions were conducted three times weekly over eight weeks. Each session was 60 minutes in duration. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Robotic Group | Total | Conventional Group |
|---|---|---|---|
| Age, Continuous | 54.57 years STANDARD_DEVIATION 13.8 | 57.13 years STANDARD_DEVIATION 15.1 | 58.14 years STANDARD_DEVIATION 17.9 |
| Region of Enrollment Austria | 6 Participants | 16 Participants | 10 Participants |
| Region of Enrollment United States | 8 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 18 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer | 5.9 change in units on a scale | Standard Deviation 13.7 |
| Robotic Group | Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer | 2.1 change in units on a scale | Standard Deviation 16.3 |
Secondary
Change in Hand and Pinch Strength
quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Time frame: Through study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Hand and Pinch Strength | 1.63 change in kilograms | Standard Deviation 7.8 |
| Robotic Group | Change in Hand and Pinch Strength | 0.84 change in kilograms | Standard Deviation 5.3 |
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.
Time frame: Through study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Hand Dexterity | 10.67 units on a scale | Standard Deviation 47.8 |
| Robotic Group | Change in Hand Dexterity | -1.12 units on a scale | Standard Deviation 24.3 |
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.
Time frame: Through study completion (taken at baseline and at 8 week study completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Mobility and Activities of Daily Living | 6.78 units on a scale | Standard Deviation 19.1 |
| Robotic Group | Change in Mobility and Activities of Daily Living | -0.36 units on a scale | Standard Deviation 12.3 |
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.
Time frame: Through study completion (taken at baseline and at 8-week study completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Motor Activity Log Amount | 9.35 units on a scale | Standard Deviation 35.1 |
| Robotic Group | Change in Motor Activity Log Amount | 2.53 units on a scale | Standard Deviation 37.7 |
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.
Time frame: Through study completion (taken at baseline and on 8 week study completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Motor Activity Log How Well | 12.79 units on a scale | Standard Deviation 29.5 |
| Robotic Group | Change in Motor Activity Log How Well | 2.6 units on a scale | Standard Deviation 35.4 |
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)
Time frame: Through study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Range of Motion Measures | 3.53 change in units on a scale | Standard Deviation 0.45 |
| Robotic Group | Change in Range of Motion Measures | 3.33 change in units on a scale | Standard Deviation 0.8 |
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.
Time frame: Through study completion, an average of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Group | Change in Spasticity Measures | -0.10 change in units on a scale | Standard Deviation 0.3 |
| Robotic Group | Change in Spasticity Measures | -0.10 change in units on a scale | Standard Deviation 0.2 |