In a recently published long-term trial (NCT03651063), results showed that post-stroke individuals experienced significant improvements following a robotic intervention involving gradual, personalized training, using sensor-embedded objects from everyday life. Overall, 100% of the participants who used the socially assistive robot (SAR) gained improvement which reached—or exceeded—the minimal clinically important difference in the action research arm test (ARAT), the gold standard for upper-extremity activity performance post-stroke.1
In the study, a total of 33 post-stroke patients with moderate-severe to mild impairment were assigned to training with SAR in addition to usual care (ROBOT group; n = 11), training with a computer in addition to usual care (COMPUTER group; n = 13), and usual care with no additional intervention (CONTROL group; n = 9). The intervention program consisted of 15 individual therapy sessions, 2-to-3 times a week, 45-60 minutes each, over a period of 5-7 weeks. Led by Shelly Levy-Tzedek, PhD, head of the Cognition, Aging, and Rehabilitation Laboratory at the Ben Gurion University, the study was conducted over a 2-year period, during which 306 sessions were held.
For the SAR intervention group, the study used the Pepper robot (SoftBank Robotics), which served as a training coach to participants. Among those assigned to this group, the instructions and the feedback on performance were displayed on the robot’s tablet screen, and the accompanying voice instructions and feedback were given via the robot’s integrated speakers and accompanied by gestures made by the robot.
During the study, the Rehabilitation Unit was locked down because of the COVID-19 pandemic. At this time, 4 participants were in the middle of intervention (1 in the ROBOT group; 3 in the COMPUTER group) and were therefore excluded from the study. In total, 26 participants (ROBOT: n = 10; COMPUTER: n = 8; CONTROL: n = 8) completed the study. At the conclusion of the study, results showed a significant effect of time and a moderate effect size for the Fugl-Meyer Upper Extremity Assessment (FMA-UE; X2 [1] = 10.714; P = .001; ES = 0.446), a primary outcome measure. Overall, the ROBOT group improved significantly between baseline (T1) and post 5-7 weeks (T2), while no significant effect of time was found for the computer or control groups.
"Use of robots could vastly improve rehabilitation outcomes by encouraging people to continue their treatment in what they feel is a non-judgmental setting," Levy-Tzedek, said in a statement.1 "Our study found that people enjoyed their interactions with the SAR, which seems to have helped improve their recovery over working with a computer or without any technological assistance."
Additional results from the study revealed a significant effect of time and a strong effect size for the ARAT (X2 [1] = 11.636; P = .001; ES = 0.506). The ROBOT group significantly improved from T1 to T2, while no significant effect of time was found for the other groups. A significant group-by-time interaction (H = 7.55, P = 0.023) was found for the between-group analysis, with a significant difference between the ROBOT and the CONTROL groups (z = −2.813, P = 0.005), while no significant difference was found between the ROBOT and COMPUTER groups or between the COMPUTER and CONTROL groups.
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On ARAT, 100% of those in the ROBOT group improved to a degree equal to or beyond the minimal clinically importance difference (MCID). Of the 8 participants in the COMPUTER group, 2 had an entrance score equal to or close to the maximal possible score, and of the remaining participants, 5 of 6 (83.3%) showed improvement that was equal to or exceeded the MCID. This was less evident in the CONTROL group, where only half (4 of 8) of participants showed improvement reaching the MCID.
On secondary outcome measures that focused on kinematics, the ROBOT group showed an effect of time on velocity (F 1,69 = 7.24; P = .009), indicating that participants who practiced with the ROBOT performed faster movements following the intervention, with no effect of time observed in the other 2 groups. In addition, the movement of the participants in the ROBOT and COMPUTER groups was significantly less jerky following the intervention compered with the CONTROL group (F2,161 = 4.647; P = .011). Investigators observed no effect of the interaction of time-by-group on trunk displacement (F 2,87 = 1.772; P = .176).
In terms of safety, increased shoulder pain was reported in 3 of the 9 participants in the CONTROL group. None of the other participants in the CONTROL group or in the intervention groups reported any discomfort or adverse events during the study period. Of note, 2 participants in the COMPUTER group dropped out of the study during the intervention period, with feelings that the intervention was not helping them.
Levy-Tzedek et al concluded that, "We demonstrated the feasibility of SAR for long-term interaction with post-stroke individuals as part of their rehabilitation program. These results are especially encouraging in light of the COVID-19 pandemic, when the requirement to reduce physical contact and to socially distance accentuates the benefit of non-contact technologies, such as SAR. Our results apply to individuals post stroke with even a minimal capacity to reach and grasp objects. The clinical benefit of SAR on stroke patients should be further investigated in studies with a larger number of participants."2
REFERENCES
1. First long-term study shows use of socially assistive robot improves stroke rehabilitation. News release. Beer-Sheva. July 24, 2024. Accessed August 7, 2024. https://apigateway.agilitypr.com/distributions/history/49ba7d64-3dff-43f6-95c9-adf6c9d94f3f
2. Feingold-Polak R, Barzel O, Levy-Tzedek S, et al. Socially assistive robot for stroke rehabilitation: a long-term in-the-wild pilot randomized controlled trial. IEEE Transactions on Neural Systems and Rehabilitation Engineering. 2024;32:1616-1626. doi:10.1109/TNSRE.2024.3387320.
Socially Assistive Robot Improves Poststroke Upper-Extremity Performance Over Long-Term Period
A recent trial showed that post-stroke patients using a socially assistive robot (SAR) for upper-extremity rehab achieved significant motor function improvements, with 100% meeting or exceeding minimal clinical improvements.
Shelly Levy-Tzedek, PhD
(Credit: ResearchGate)
In a recently published long-term trial (NCT03651063), results showed that post-stroke individuals experienced significant improvements following a robotic intervention involving gradual, personalized training, using sensor-embedded objects from everyday life. Overall, 100% of the participants who used the socially assistive robot (SAR) gained improvement which reached—or exceeded—the minimal clinically important difference in the action research arm test (ARAT), the gold standard for upper-extremity activity performance post-stroke.1
In the study, a total of 33 post-stroke patients with moderate-severe to mild impairment were assigned to training with SAR in addition to usual care (ROBOT group; n = 11), training with a computer in addition to usual care (COMPUTER group; n = 13), and usual care with no additional intervention (CONTROL group; n = 9). The intervention program consisted of 15 individual therapy sessions, 2-to-3 times a week, 45-60 minutes each, over a period of 5-7 weeks. Led by Shelly Levy-Tzedek, PhD, head of the Cognition, Aging, and Rehabilitation Laboratory at the Ben Gurion University, the study was conducted over a 2-year period, during which 306 sessions were held.
For the SAR intervention group, the study used the Pepper robot (SoftBank Robotics), which served as a training coach to participants. Among those assigned to this group, the instructions and the feedback on performance were displayed on the robot’s tablet screen, and the accompanying voice instructions and feedback were given via the robot’s integrated speakers and accompanied by gestures made by the robot.
During the study, the Rehabilitation Unit was locked down because of the COVID-19 pandemic. At this time, 4 participants were in the middle of intervention (1 in the ROBOT group; 3 in the COMPUTER group) and were therefore excluded from the study. In total, 26 participants (ROBOT: n = 10; COMPUTER: n = 8; CONTROL: n = 8) completed the study. At the conclusion of the study, results showed a significant effect of time and a moderate effect size for the Fugl-Meyer Upper Extremity Assessment (FMA-UE; X2 [1] = 10.714; P = .001; ES = 0.446), a primary outcome measure. Overall, the ROBOT group improved significantly between baseline (T1) and post 5-7 weeks (T2), while no significant effect of time was found for the computer or control groups.
"Use of robots could vastly improve rehabilitation outcomes by encouraging people to continue their treatment in what they feel is a non-judgmental setting," Levy-Tzedek, said in a statement.1 "Our study found that people enjoyed their interactions with the SAR, which seems to have helped improve their recovery over working with a computer or without any technological assistance."
Additional results from the study revealed a significant effect of time and a strong effect size for the ARAT (X2 [1] = 11.636; P = .001; ES = 0.506). The ROBOT group significantly improved from T1 to T2, while no significant effect of time was found for the other groups. A significant group-by-time interaction (H = 7.55, P = 0.023) was found for the between-group analysis, with a significant difference between the ROBOT and the CONTROL groups (z = −2.813, P = 0.005), while no significant difference was found between the ROBOT and COMPUTER groups or between the COMPUTER and CONTROL groups.
READ MORE: Gene Therapy LX2006 Positively Impacts Cardiac Biomarkers of Friedreich Ataxia, Clinical Data Show
On ARAT, 100% of those in the ROBOT group improved to a degree equal to or beyond the minimal clinically importance difference (MCID). Of the 8 participants in the COMPUTER group, 2 had an entrance score equal to or close to the maximal possible score, and of the remaining participants, 5 of 6 (83.3%) showed improvement that was equal to or exceeded the MCID. This was less evident in the CONTROL group, where only half (4 of 8) of participants showed improvement reaching the MCID.
On secondary outcome measures that focused on kinematics, the ROBOT group showed an effect of time on velocity (F 1,69 = 7.24; P = .009), indicating that participants who practiced with the ROBOT performed faster movements following the intervention, with no effect of time observed in the other 2 groups. In addition, the movement of the participants in the ROBOT and COMPUTER groups was significantly less jerky following the intervention compered with the CONTROL group (F2,161 = 4.647; P = .011). Investigators observed no effect of the interaction of time-by-group on trunk displacement (F 2,87 = 1.772; P = .176).
In terms of safety, increased shoulder pain was reported in 3 of the 9 participants in the CONTROL group. None of the other participants in the CONTROL group or in the intervention groups reported any discomfort or adverse events during the study period. Of note, 2 participants in the COMPUTER group dropped out of the study during the intervention period, with feelings that the intervention was not helping them.
Levy-Tzedek et al concluded that, "We demonstrated the feasibility of SAR for long-term interaction with post-stroke individuals as part of their rehabilitation program. These results are especially encouraging in light of the COVID-19 pandemic, when the requirement to reduce physical contact and to socially distance accentuates the benefit of non-contact technologies, such as SAR. Our results apply to individuals post stroke with even a minimal capacity to reach and grasp objects. The clinical benefit of SAR on stroke patients should be further investigated in studies with a larger number of participants."2
REFERENCES
1. First long-term study shows use of socially assistive robot improves stroke rehabilitation. News release. Beer-Sheva. July 24, 2024. Accessed August 7, 2024. https://apigateway.agilitypr.com/distributions/history/49ba7d64-3dff-43f6-95c9-adf6c9d94f3f
2. Feingold-Polak R, Barzel O, Levy-Tzedek S, et al. Socially assistive robot for stroke rehabilitation: a long-term in-the-wild pilot randomized controlled trial. IEEE Transactions on Neural Systems and Rehabilitation Engineering. 2024;32:1616-1626. doi:10.1109/TNSRE.2024.3387320.
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NeurologyLive® Friday 5 — September 13, 2024
Episode 123: Previewing Cleveland Clinic's Epilepsy Summit
Research Finds Connection Between Increased Hepatitis E Virus Seroprevalence and Chronic Inflammatory Demyelinating Polyneuropathy
Multisymptomatic Care in Parkinson's Disease
Gene Therapy RGX-121 Demonstrates Promising Results in Pivotal CAMPSIITE Trial of Hunter Syndrome
Phase 1/2 Studies Support Higher Dose Regimen of STK-001 for Dravet Syndrome Treatment