NCT05321290|Completed
Robotic Therapy Program for the Arm After Stroke
Evaluation of an Outpatient Upper Limb Robotic Therapy Program for Older Adult Chronic Stroke Survivors
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Evaluation of an Outpatient Upper Limb Robotic Therapy Program for Older Adult Chronic Stroke Survivors
Sponsor study identifier
interventional
9
0 countries
N/A
Study Start
October 15, 2015
Actual (reported)Primary Completion
November 11, 2016
Actual (reported)Study Completion
November 11, 2016
Actual (reported)The aim of this study is to evaluate an outpatient stroke rehabilitation program that uses therapy goal setting and a newly developed, low cost robot for upper limb therapy. The prototype robot has been developed by Toronto Rehab and University of Toronto along with an industry Partner, Quanser Inc. As a prototype, the robot is undergoing research for its effectiveness and feasibility and not currently used in usual therapy. Participants in this study will receive assessments, set their own therapy goals, and work with the robot. Therapy program outcomes for each participant will be evaluated in several ways. These will include comparing changes in values recorded directly from the robot (e.g. speed of movement), clinical assessments of upper limb abilities, and achievement of therapy goals. Program satisfaction will be recorded using questionnaires, surveys, and interviews. Feasibility of and requirements for delivering the program will be examined through participant enrollment, hours in the therapy program, hours of robot use, travel time and distances, and other participant factors, and staffing needs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 11, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2015
Actual (reported)November 11, 2016
Actual (reported)November 11, 2016
Actual (reported)February 1, 2022
Actual (reported)April 11, 2022
Actual (reported)Change from baseline mean movement velocity of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
The robotic system automatically and continuously collects data from sensors when the robot end effector is moved by the participant's arm while using the robot. Robotic data on arm movement are collected at the start of each assessment and therapy session during calibration exercises. Data for the mean movement velocity metric were extracted from each movement and averaged over each session (day). Each session's mean movement velocity over the course of the participant's program was plotted and the mean movement velocity was analyzed for changes from the baseline.
A Phase (4 times a week in weeks 1-2), B Phase (during each therapy session [3 times a week] and each evaluation session [1 time every 2 weeks] over 8 weeks [total 28 times]), A Phase (3 times a week in weeks 11-12), follow-up (1 time in week 16)
Change from baseline movement smoothness of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
The robotic system automatically and continuously collects data from sensors when the robot end effector is moved by the participant's arm while using the robot. Robotic data on arm movement are collected at the start of each assessment and therapy session during calibration exercises. Data for the movement smoothness metric were extracted from each movement and averaged over each session (day). Movement smoothness was determined using root mean square (RMS) jerk (normalized by movement duration). Each session's movement smoothness over the course of the participant's program was plotted and the movement smoothness was analyzed for changes from the baseline.
A Phase (4 times a week in weeks 1-2), B Phase (during each therapy session [3 times a week] and each evaluation session [1 time every 2 weeks] over 8 weeks [total 28 times]), A Phase (3 times a week in weeks 11-12), follow-up (1 time in week 16)
Change from baseline movement error of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
Fugl-Meyer Assessment - Upper Extremity (FMA - UE)
A Phase (weekly in 1st and 2nd weeks), B Phase (every 2 weeks during 8-week intervention phase), A Phase (weekly in 11-12th weeks), and follow-up (once at 16 weeks)
Action Arm Research Test (ARAT)
A Phase (weekly in 1st and 2nd weeks), B Phase (every 2 weeks during 8-week intervention phase), A Phase (weekly in 11-12th weeks), and follow-up (once at 16 weeks)
Goal Attainment Scaling (GAS)
Identify therapy goals at baseline (once in week 1), evaluate progress at end of program (once at end of 2nd A phase week 12), and at follow-up (once at week 16), reassessment may occur, as needed (e.g. participant achieves goal during B phase)
Motor Activity Log (MAL)
A Phase (twice in week 1, once in week 2), B Phase (once a week during 8-week intervention phase), A Phase (once a week in 11-12th weeks), and follow-up (once at 16 weeks)
Quebec User Evaluation of Satisfaction with Technology (QUEST) 2.0 Scale
Administered in last visit of 2nd A Phase (12th week)
Open-ended interview questions
Administered in last visit of 2nd A phase (12th week)
Summative evaluation of program feasibility (yes/no)
Data recorded throughout the entire study, and through study completion for each participant (16 weeks/participant).
The intervention will consist of identification of 3-5 therapy goals using GAS (Turner-Stoke, 2009), joint planning with a therapist to achieve these goals during the program, and a robotic therapy plan. The robotic therapy plan will be negotiated with participants and consist of 3 sessions (about 1 h) per week for 8 weeks. The plan will detail the types of robotic activities (e.g. selection of interactive activities and games) to be completed by the participant. Homework relevant to participants' therapy goals will also be developed after each session. The intervention for each participant will be 24 robotic therapy sessions and 10 progress review sessions. The robotic system includes a tabletop 2-degree of freedom haptic robot that provides assisted and resisted shoulder and elbow movement therapy (Lu et. al, 2012). Interactive games are used with the system to engage and motivate participants to continue therapy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lu E, Wang R, Huq R, Gardner D, Karam P, Zabjek K, Hebert D, Boger J, Mihailidis A. Development of a robotic device for upper limb stroke rehabilitation: A user-centered design approach. Paladyn, Journal of Behavioral Robotics. 2011;2(4): 176-184. https://doi.org/10.2478/s13230-012-0009-0
Graham JE, Karmarkar AM, Ottenbacher KJ. Small sample research designs for evidence-based rehabilitation: issues and methods. Arch Phys Med Rehabil. 2012 Aug;93(8 Suppl):S111-6. doi: 10.1016/j.apmr.2011.12.017. Epub 2012 May 8.
Barlow, DH and Hersen, M. Single case experimental designs: Strategies for studying behaviour change. New York: Pergamon Press, 1984.
Rosalie H Wang, PhD
University Health Network/University of Toronto
9 participants (actual enrollment reported by the registry).
First Submitted
February 1, 2022
First Posted
April 11, 2022
Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
The robotic system automatically and continuously collects data from sensors when the robot end effector is moved by the participant's arm while using the robot. Robotic data on arm movement are collected at the start of each assessment and therapy session during calibration exercises. Data for the movement error metric were extracted from each movement and averaged over each session (day). Movement error was determined using the shortest path length divided by actual path length. Each session's movement error over the course of the participant's program was plotted and the movement error was analyzed for changes from the baseline.
A Phase (4 times a week in weeks 1-2), B Phase (during each therapy session [3 times a week] and each evaluation session [1 time every 2 weeks] over 8 weeks [total 28 times]), A Phase (3 times a week in weeks 11-12), follow-up (1 time in week 16)
Change from baseline range of motion of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
The robotic system automatically and continuously collects data from sensors when the robot end effector is moved by the participant's arm while using the robot. Robotic data on arm movement are collected at the start of each assessment and therapy session during calibration exercises. Data for the range of motion metric were extracted (X and Y range) and averaged over each session (day). Each session's range of motion (total reachable area) over the course of the participant's program was plotted and the range of motion was analyzed for changes from the baseline.
A Phase (4 times a week in weeks 1-2), B Phase (during each therapy session [3 times a week] and each evaluation session [1 time every 2 weeks] over 8 weeks [total 28 times]), A Phase (3 times a week in weeks 11-12), follow-up (1 time in week 16)
Contact the study team to confirm eligibility.
Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009 Apr;23(4):362-70. doi: 10.1177/0269215508101742. Epub 2009 Jan 29.
Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993 Jan;24(1):58-63. doi: 10.1161/01.str.24.1.58.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
Wood-Dauphinee SL, Williams JI, Shapiro SH. Examining outcome measures in a clinical study of stroke. Stroke. 1990 May;21(5):731-9. doi: 10.1161/01.str.21.5.731.
Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.
Platz T, Pinkowski C, van Wijck F, Kim IH, di Bella P, Johnson G. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil. 2005 Jun;19(4):404-11. doi: 10.1191/0269215505cr832oa.
Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
Uswatte G, Taub E, Morris D, Vignolo M, McCulloch K. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005 Nov;36(11):2493-6. doi: 10.1161/01.STR.0000185928.90848.2e. Epub 2005 Oct 13.
Demers L, et al. Quebec User Evaluation of Satisfaction with Assistive Technology QUEST 2.0. New York (NY): Marcia J. Scherer PhD Institute for Matching Person and Technology, 2000.
Study Start
October 15, 2015
Actual (reported)Primary Completion
November 11, 2016
Actual (reported)Study Completion
November 11, 2016
Actual (reported)Last Updated
April 29, 2022
Record last verified: 2022-04
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