scholarly journals Action Observation Treatment-Based Exoskeleton (AOT-EXO) for Upper Extremity After Stroke: Study Protocol for a Randomised Controlled Trial

2021 ◽  
Author(s):  
Zejian Chen ◽  
Nan Xia ◽  
Chang He ◽  
Minghui Gu ◽  
Jiang Xu ◽  
...  
Keyword(s):  
Upper Extremity ◽  
Functional Disability ◽  
Motor Evoked Potentials ◽  
Action Observation ◽  
Controlled Trial ◽  
Measurement Unit ◽  
Motor Deficit ◽  
Robot Assisted ◽  
Clinical Trial Registry ◽  
Resting Motor Threshold

Abstract Background Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability. Robot-assisted training is effective in promoting upper extremity muscle strength and motor impairment recovery after stroke. Additionally, action observation treatment can enhance the effects of physical and occupational therapy by increasing neural activation. The AOT-EXO trial aims to investigate whether action observation treatment coupled with robot-assisted training could enhance motor circuit activation and improve upper extremity motor outcomes. Methods The AOT-EXO trial is a multicentre, prospective, three-group randomized controlled trial (RCT). We will screen and enrol 132 eligible patients in the trial implemented in the Department of Rehabilitation Medicine of Tongji Hospital, Optical Valley Branch of Tongji Hospital and Hubei Province Hospital of Integrated Chinese & Western Medicine in Wuhan, China. Prior to study participation, written informed consent will be obtained from eligible patients in accordance with the Declaration of Helsinki. The enrolled stroke patients will be randomised to three groups: the CT group (conventional therapy); EXO group (exoskeleton therapy) and AOT-EXO group (action observation treatment-based exoskeleton therapy). The patients will undergo blinded assessments at baseline, post-intervention (after 4 weeks) and follow-up (after 12 weeks). The primary outcome will be the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes. Discussion This trial will provide evidence regarding the feasibility and efficacy of the action observation treatment-based exoskeleton (AOT-EXO) for post-stroke upper extremity rehabilitation and elucidate the potential underlying kinematic and neurological mechanisms. Trial Registration: Chinese Clinical Trial Registry identifier: ChiCTR1900026656. Registered on 17 October 2019.

scholarly journals Action observation treatment-based exoskeleton (AOT-EXO) for upper extremity after stroke: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zejian Chen ◽  
Nan Xia ◽  
Chang He ◽  
Minghui Gu ◽  
Jiang Xu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Upper Extremity ◽  
Motor Evoked Potentials ◽  
Action Observation ◽  
Controlled Trial ◽  
Measurement Unit ◽  
Motor Deficit ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Resting Motor Threshold

Abstract Background Stroke produces multiple symptoms, including sensory, motor, cognitive and psychological dysfunctions, among which motor deficit is the most common and is widely recognized as a major contributor to long-term functional disability. Robot-assisted training is effective in promoting upper extremity muscle strength and motor impairment recovery after stroke. Additionally, action observation treatment can enhance the effects of physical and occupational therapy by increasing neural activation. The AOT-EXO trial aims to investigate whether action observation treatment coupled with robot-assisted training could enhance motor circuit activation and improve upper extremity motor outcomes. Methods The AOT-EXO trial is a multicentre, prospective, three-group randomized controlled trial (RCT). We will screen and enrol 132 eligible patients in the trial implemented in the Department of Rehabilitation Medicine of Tongji Hospital, Optical Valley Branch of Tongji Hospital and Hubei Province Hospital of Integrated Chinese & Western Medicine in Wuhan, China. Prior to study participation, written informed consent will be obtained from eligible patients in accordance with the Declaration of Helsinki. The enrolled stroke patients will be randomized to three groups: the CT group (conventional therapy); EXO group (exoskeleton therapy) and AOT-EXO group (action observation treatment-based exoskeleton therapy). The patients will undergo blinded assessments at baseline, post-intervention (after 4 weeks) and follow-up (after 12 weeks). The primary outcome will be the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include the Action Research Arm Test (ARAT), modified Barthel Index (MBI), kinematic metrics assessed by inertial measurement unit (IMU), resting motor threshold (rMT), motor evoked potentials (MEP), functional magnetic resonance imaging (fMRI) and safety outcomes. Discussion This trial will provide evidence regarding the feasibility and efficacy of the action observation treatment-based exoskeleton (AOT-EXO) for post-stroke upper extremity rehabilitation and elucidate the potential underlying kinematic and neurological mechanisms. Trial registration Chinese Clinical Trial Registry ChiCTR1900026656. Registered on 17 October 2019.

scholarly journals Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS

2009 ◽  
Vol 23 (8) ◽  
pp. 775-783 ◽  
Author(s):  
Albert C. Lo ◽  
Peter Guarino ◽  
Hermano I. Krebs ◽  
Bruce T. Volpe ◽  
Christopher T. Bever ◽  
...  
Keyword(s):  
Upper Extremity ◽  
Motor Function ◽  
Controlled Trial ◽  
Chronic Stroke ◽  
Robot Assisted ◽  
Anterior Circulation ◽  
Multicenter Randomized Controlled Trial ◽  
Index Stroke ◽  
Wolf Motor Function Test ◽  
Upper Extremity Impairment

Background. Chronic upper extremity impairment due to stroke has significant medical, psychosocial, and financial consequences, but few studies have examined the effectiveness of rehabilitation therapy during the chronic stroke period. Objective. To test the safety and efficacy of the MIT-Manus robotic device for chronic upper extremity impairment following stroke. Methods. The VA Cooperative Studies Program initiated a multicenter, randomized, controlled trial in November 2006 (VA ROBOTICS). Participants with upper extremity impairment ≥6 months poststroke were randomized to robot-assisted therapy (RT), intensive comparison therapy (ICT), or usual care (UC). RT and ICT consisted of three 1-hour treatment sessions per week for 12 weeks. The primary outcome was change in the Fugl-Meyer Assessment upper extremity motor function score at 12 weeks relative to baseline. Secondary outcomes included the Wolf Motor Function Test and the Stroke Impact Scale. Results. A total of 127 participants were randomized: 49 to RT, 50 to ICT, and 28 to UC. The majority of participants were male (96%), with a mean age of 65 years. The primary stroke type was ischemic (85%), and 58% of strokes occurred in the anterior circulation. Twenty percent of the participants reported a stroke in addition to their index stroke. The average time from the index stroke to enrollment was 56 months (range, 6 months to 24 years). The mean Fugl-Meyer score at entry was 18.9. Conclusions. VA ROBOTICS demonstrates the feasibility of conducting multicenter clinical trials to rigorously test new rehabilitative devices before their introduction to clinical practice. The results are expected in early 2010.

scholarly journals Proprioceptive Training with Visual Feedback Improves Upper Limb Function in Stroke Patients: A Pilot Study

2022 ◽  
Vol 2022 ◽  
pp. 1-10
Author(s):  
Jieying He ◽  
Chong Li ◽  
Jiali Lin ◽  
Beibei Shu ◽  
Bin Ye ◽  
...  
Keyword(s):  
Upper Extremity ◽  
Motor Function ◽  
Visual Feedback ◽  
Upper Limb ◽  
Negative Impact ◽  
Controlled Trial ◽  
Sensory Stimulation ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Proprioceptive Training

Proprioceptive deficit is one of the common sensory impairments following stroke and has a negative impact on motor performance. However, evidence-based training procedures and cost-efficient training setups for patients with poststroke are still limited. We compared the effects of proprioceptive training versus nonspecific sensory stimulation on upper limb proprioception and motor function rehabilitation. In this multicenter, single-blind, randomized controlled trial, 40 participants with poststroke hemiparesis were enrolled from 3 hospitals in China. Participants were assigned randomly to receive proprioceptive training involving passive and active movements with visual feedback (proprioceptive training group [PG]; n = 20 ) or nonspecific sensory stimulation (control group [CG]; n = 20 ) 20 times in four weeks. Each session lasted 30 minutes. A clinical assessor blinded to group assignment evaluated patients before and after the intervention. The primary outcome was the change in the motor subscale of the Fugl-Meyer assessment for upper extremity (FMA-UE-M). Secondary outcomes were changes in box and block test (BBT), thumb localization test (TLT), the sensory subscale of the Fugl-Meyer assessment for upper extremity (FMA-UE-S), and Barthel Index (BI). The results showed that the mean change scores of FMA-UE were significantly greater in the PG than in the CG ( p = 0.010 for FMA-UE-M, p = 0.033 for FMA-UE-S). The PG group was improved significantly in TLT ( p = 0.010 ) and BBT ( p = 0.027 ), while there was no significant improvement in TLT ( p = 0.083 ) and BBT ( p = 0.107 ) for the CG group. The results showed that proprioceptive training was effective in improving proprioception and motor function of the upper extremity in patients with poststroke. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2000037808).

Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit

2019 ◽  
Vol 34 (4) ◽  
pp. 268-279 ◽  
Author(s):  
David M. Morris ◽  
Edward Taub ◽  
Victor W. Mark ◽  
Wei Liu ◽  
Lisa Brenner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Upper Extremity ◽  
Controlled Trial ◽  
Motor Deficit ◽  
Randomized Controlled ◽  
Ci Therapy

scholarly journals Running barefoot leads to lower running stability compared to shod running - results from a randomized controlled study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Karsten Hollander ◽  
Daniel Hamacher ◽  
Astrid Zech
Keyword(s):  
Controlled Trial ◽  
Drop Out ◽  
Treadmill Running ◽  
Measurement Unit ◽  
Controlled Study ◽  
Local Dynamic ◽  
Long Term Effects ◽  
Barefoot Running ◽  
Random Intercept ◽  
Short Time

AbstractLocal dynamic running stability is the ability of a dynamic system to compensate for small perturbations during running. While the immediate effects of footwear on running biomechanics are frequently investigated, no research has studied the long-term effects of barefoot vs. shod running on local dynamic running stability. In this randomized single-blinded controlled trial, young adults novice to barefoot running were randomly allocated to a barefoot or a cushioned footwear running group. Over an 8-week-period, both groups performed a weekly 15-min treadmill running intervention in the allocated condition at 70% of their VO2 max velocity. During each session, an inertial measurement unit on the tibia recorded kinematic data (angular velocity) which was used to determine the short-time largest Lyapunov exponents as a measure of local dynamic running stability. One hundred running gait cycles at the beginning, middle, and end of each running session were analysed using one mixed linear multilevel random intercept model. Of the 41 included participants (48.8% females), 37 completed the study (drop-out = 9.7%). Participants in the barefoot running group exhibited lower running stability than in the shod running group (p = 0.037) with no changes during the intervention period (p = 0.997). Within a single session, running stability decreased over the course of the 15-min run (p = 0.012) without differences between both groups (p = 0.060). Changing from shod to barefoot running reduces running stability not only in the acute phase but also in the longer term. While running stability is a relatively new concept, it enables further insight into the biomechanical influence of footwear.

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