Trial Outcomes & Findings for Robotic and Conventional Hand Therapy After Stroke (NCT NCT03020576)
NCT ID: NCT03020576
Last Updated: 2018-01-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
Results posted on
2018-01-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Robotic and Conventional Hand Therapy After Stroke
Baseline characteristics by cohort
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.14 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
54.57 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
57.13 years
STANDARD_DEVIATION 15.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
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
|
2.1 change in units on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Through study completion, an average of 8 weeksquantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Range of Motion Measures
|
3.53 change in units on a scale
Standard Deviation 0.45
|
3.33 change in units on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Through study completion, an average of 8 weeksquantitative assessment of hand strength using standard dynamometry measurements in units of kilograms
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Hand and Pinch Strength
|
1.63 change in kilograms
Standard Deviation 7.8
|
0.84 change in kilograms
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Motor Activity Log Amount
|
9.35 units on a scale
Standard Deviation 35.1
|
2.53 units on a scale
Standard Deviation 37.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Mobility and Activities of Daily Living
|
6.78 units on a scale
Standard Deviation 19.1
|
-0.36 units on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Through study completion, an average of 8 weeksThe 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.
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Hand Dexterity
|
10.67 units on a scale
Standard Deviation 47.8
|
-1.12 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Through study completion, an average of 8 weeksThe 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.
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Spasticity Measures
|
-0.10 change in units on a scale
Standard Deviation 0.3
|
-0.10 change in units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Conventional Group
n=14 Participants
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.
|
Robotic Group
n=14 Participants
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.
|
|---|---|---|
|
Change in Motor Activity Log How Well
|
12.79 units on a scale
Standard Deviation 29.5
|
2.6 units on a scale
Standard Deviation 35.4
|
Adverse Events
Conventional Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Robotic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauri Bishop, PT, DPT Research Physical Therapist
Columbia University Medical Center/ Dept. of Rehabilitation & Regenerative Medicine
Phone: 212-305-6095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place