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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| New York University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Therapy | Active Comparator | 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. |
|
| Robotic Therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Through study completion, an average of 8 weeks |
| Change in Hand and Pinch Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Stein, MD | Columbia University | Principal Investigator |
| Raimund Helbok, MD | Innsbruck Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| Innsbruck Medical University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | change in units on a scale | Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauri Bishop, PT, DPT Research Physical Therapist | Columbia University Medical Center/ Dept. of Rehabilitation & Regenerative Medicine | 212-305-6095 | LB2413@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms |
| Through study completion, an average of 8 weeks |
| 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. | Through study completion (taken at baseline and at 8-week study completion) |
| 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. | Through study completion (taken at baseline and at 8 week study completion) |
| 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. | Through study completion, an average of 8 weeks |
| 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. | Through study completion, an average of 8 weeks |
| 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. | Through study completion (taken at baseline and on 8 week study completion) |
| Innsbruck |
| 6020 |
| Austria |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
| 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) | Posted | Mean | Standard Deviation | change in units on a scale | Through study completion, an average of 8 weeks |
|
|
|
| Secondary | Change in Hand and Pinch Strength | quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms | Posted | Mean | Standard Deviation | change in kilograms | Through study completion, an average of 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Through study completion (taken at baseline and at 8-week study completion) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Through study completion (taken at baseline and at 8 week study completion) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Through study completion, an average of 8 weeks |
|
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|
| 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. | Posted | Mean | Standard Deviation | change in units on a scale | Through study completion, an average of 8 weeks |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Through study completion (taken at baseline and on 8 week study completion) |
|
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|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 14 | 0 | 14 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |