StrokeNCT05321290
Robotic Therapy Program for the Arm After Stroke
A study testing Robotic Therapy Program in people with Stroke, run by University Health Network, Toronto.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2015to 11 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke survivor (at least 6 months post stroke)
- Completed all outpatient stroke rehabilitation
- Upper limb recovery between stage 3 to 5 (out of 7) in the arm on the Chedoke McMaster Stroke Assessment (CMSA) Stages of Motor Impairment (Gowland et. al, 1993)
- Able to attend 3 - 4 visits per week at the clinic for 12 weeks with a 4 week follow up
- Able to tolerate up to 1 hour of activity in seated position
- Able to speak English
- Able to give informed consent and sign consent form
Who cannot join
- Significant upper limb neurological or musculoskeletal condition other than stroke
- Shoulder subluxation or significant pain that limits active mobility treatment
About this study
Official title: Evaluation of an Outpatient Upper Limb Robotic Therapy Program for Older Adult Chronic Stroke Survivors
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.
Read the detailed description
This study evaluates an outpatient stroke rehabilitation program that applies therapy goal setting and a newly developed, low cost robotic system for upper limb therapy. The specific objectives of the study include the following:
- To evaluate the efficacy of the program in improving upper limb movement function and goal achievement in older adult chronic stroke survivors
- To evaluate older adult chronic stroke survivor satisfaction with the rehabilitation program (e.g. overall therapy program, robotic system, service delivery)
- To determine the feasibility of and requirements to deliver an outpatient upper limb robotic therapy program in a drop-in clinic setting for older adult chronic stroke survivors
The study uses a multiple single subject research design (SSRD) with 3 study phases and a follow-up. The phases include:
A - Baseline (no intervention, assessment only, 2 weeks) B - Intervention (therapy program, assessment and therapy, 8 weeks) A - Baseline (maintenance with no intervention, assessment only, 2 weeks) A follow-up assessment will be conducted 4 weeks after the phases are completed.
With this study design, each participant's progress can be examined on a person by person basis.
Baseline information collected from participants will include demographics (e.g. age, sex, hand dominance), medical history including type and location of stroke, cognition (screened using the Mini Mental State Exam), communication, vision, hearing, pain (Borg CR10 Scale), fatigue (Fatigue Severity Scale), depression (using Beck's Depression Inventory), functional abilities (Functional Independence Measure), performance of daily activities, treatment precautions, and therapy goals (Goal Attainment Scaling, GAS).
During each of the study phases, robotic and upper limb function assessments will be carried out as described in the Outcomes section. The therapy program will be carried out as described in the Intervention section. At the end of the 3 phases, therapy goals identified in the GAS will be reviewed and the Functional Independence Measure will be re-evaluated. Participants will be asked about their satisfaction with the program using the outcome measures and methods described in the Outcomes section. Participants will be asked to return for a follow up assessment 4 weeks later. If sessions are missed (e.g. owing to illness), attempts will be made to reschedule missed sessions, in which case the total duration of the study will be extended. If participants are unable to attend or miss multiple sessions, participation in the program will be reevaluated and negotiated with the participant. Researchers will keep continuous records of information for program feasibility and requirements.
- Conditions
- Stroke
- Being tested
- Robotic Therapy Program
- Keywords
- Rehabilitation, Upper limb, Chronic stroke, Robotics, Older adult, Goal setting
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Therapy ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| Robotic Therapy Program | Experimental | 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. Receives: Other: Robotic Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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)
Secondary outcomes (6)
Fugl-Meyer Assessment - Upper Extremity (FMA - UE)
The Fugl-Meyer Assessment - Upper Extremity (FMA - UE) (Fugl-Meyer et. al, 1975) will be used to evaluate changes in motor impairment or recovery. The FMA assesses motor functioning, balance, sensation and joint functioning in stroke survivors with upper and lower extremity hemiplegia. The assessment has been widely used to describe motor recovery and assess treatment outcomes (Fugl-Meyer et. al, 1975, Gladstone et. al 2002). It has been used with stroke survivors in the acute and chronic stages of recovery in hospital settings and community settings (Wood-Dauphinee et al, 1990). The sections of the FMA may be used separately, and in this study only the UE section will be used. It is estimated to take approximately 20 minutes to complete.
Measured: 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)
The Action Research Arm Test (ARAT) will be used as a measure for arm function and activity limitation. The ARAT was designed to be used with individuals with hemiplegia following cortical damage (Lyle, 1981). There are four subscales including grasp, grip, pinch and gross movement and 19 items within all the subscales. As an assessment to measure upper extremity activity limitation, it examines the abilities to manipulate everyday objects with varying size, weight, and shape (Platz et al, 2005). Equipment for the procedures is standardized.
Measured: 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)
Goal Attainment Scaling (GAS) is used to facilitate the collaborative development and evaluation of goals used in the therapy program (Turner-Stokes, 2009). GAS enables quantification of goal achievement using a 5-point scale that ranges from -2 to +2. The scoring approach used for GAS is taken from Turner-Stokes (2009). The approach includes a method for producing an aggregated goal attainment score.
Measured: 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)
The Motor Activity Log (MAL) (Taub et al, 1993) will be used as a measure of affected upper limb use in daily activities. The MAL-14 consists of a semi-structured interview identifying 14 functional tasks that asks participants to report on a 6-point scale, how often and how well he/she performs the tasks, over the past week. The MAL-14 is a standardized version (Uswatte et al 2005). Scores for amount of use and quality of movement are scored separately.
Measured: 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
The QUEST 2.0 will be completed by participants to assess their satisfaction with the therapy program using the robotic device (Demers et al, 2000). The items collectively form a satisfaction evaluation of interest in this study. The tool has 12 items, rated on a 6-point scale: Dimensions, Weight, Adjustments, Safety, Durability, Easy to use, Comfort, Effectiveness, Service delivery, Repairs/servicing, Professional service, and Follow-up services. Eight items will be scored in this study as they are the most relevant (Dimensions, Weight, Adjustments, Safety, Easy to use, Comfort, Effectiveness, Service delivery). The QUEST 2.0 score is calculated by averaging the results for all scored items.
Measured: Administered in last visit of 2nd A Phase (12th week)
Outpatient Service Satisfaction Survey
The Toronto Rehabilitation Institute - University Health Network survey will help to evaluate participant satisfaction with the therapy program (e.g. overall therapy program, robotic therapy system, service delivery). It has a scale to indicate satisfaction (Excellent, Very good, Good, Fair, Poor) with additional opportunities to comment on each survey item.
Measured: Administered in last visit of 2nd A Phase (12th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Oct 2015
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A multiple SSRD study using an ABA design and follow-up will be conducted with up to 10 participants. This study design focuses on within-participant comparisons of repeated performance outcome measurements over time, which will be critical for determining the clinical efficacy of the therapy program for individual participants (Graham et al, 2012). The SSRD will be supplemented with questionnaires, and survey and open-ended interview questions.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Drummond Foundation
- Responsible party
- Principal investigator, Rosalie Wang, University Health Network, Toronto
- Investigators
- Rosalie H Wang, PhD, Principal investigator, University Health Network/University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321290
- Sponsor's protocol ID
- 14-8702
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22580169Barlow, DH and Hersen, M. Single case experimental designs: Strategies for studying behaviour change. New York: Pergamon Press, 1984.
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.
PubMed 19179355Gowland 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.
PubMed 8418551Fugl-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.
PubMed 1135616Gladstone 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.
PubMed 12234086Wood-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.
PubMed 2339453Lyle 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.
PubMed 7333761Platz 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.
PubMed 15929509Taub 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.
PubMed 8466415Uswatte 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.
PubMed 16224078Demers 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 at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Outpatient Upper Limb Robotic Therapy Program for Older Adult Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT05321290
- Acronym / sponsor ID
- 14-8702
- Conditions
- Stroke
- Keywords
- Rehabilitation, Upper limb, Chronic stroke, Robotics, Older adult, Goal setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Drummond Foundation
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates an outpatient stroke rehabilitation program that applies therapy goal setting and a newly developed, low cost robotic system for upper limb therapy. The specific objectives of the study include the following:
- To evaluate the efficacy of the program in improving upper limb movement function and goal achievement in older adult chronic stroke survivors
- To evaluate older adult chronic stroke survivor satisfaction with the rehabilitation program (e.g. overall therapy program, robotic system, service delivery)
- To determine the feasibility of and requirements to deliver an outpatient upper limb robotic therapy program in a drop-in clinic setting for older adult chronic stroke survivors
The study uses a multiple single subject research design (SSRD) with 3 study phases and a follow-up. The phases include:
A - Baseline (no intervention, assessment only, 2 weeks) B - Intervention (therapy program, assessment and therapy, 8 weeks) A - Baseline (maintenance with no intervention, assessment only, 2 weeks) A follow-up assessment will be conducted 4 weeks after the phases are completed.
With this study design, each participant's progress can be examined on a person by person basis.
Baseline information collected from participants will include demographics (e.g. age, sex, hand dominance), medical history including type and location of stroke, cognition (screened using the Mini Mental State Exam), communication, vision, hearing, pain (Borg CR10 Scale), fatigue (Fatigue Severity Scale), depression (using Beck's Depression Inventory), functional abilities (Functional Independence Measure), performance of daily activities, treatment precautions, and therapy goals (Goal Attainment Scaling, GAS).
During each of the study phases, robotic and upper limb function assessments will be carried out as described in the Outcomes section. The therapy program will be carried out as described in the Intervention section. At the end of the 3 phases, therapy goals identified in the GAS will be reviewed and the Functional Independence Measure will be re-evaluated. Participants will be asked about their satisfaction with the program using the outcome measures and methods described in the Outcomes section. Participants will be asked to return for a follow up assessment 4 weeks later. If sessions are missed (e.g. owing to illness), attempts will be made to reschedule missed sessions, in which case the total duration of the study will be extended. If participants are unable to attend or miss multiple sessions, participation in the program will be reevaluated and negotiated with the participant. Researchers will keep continuous records of information for program feasibility and requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multiple SSRD study using an ABA design and follow-up will be conducted with up to 10 participants. This study design focuses on within-participant comparisons of repeated performance outcome measurements over time, which will be critical for determining the clinical efficacy of the therapy program for individual participants (Graham et al, 2012). The SSRD will be supplemented with questionnaires, and survey and open-ended interview questions.
| Arm | Type | Receives |
|---|---|---|
| Robotic Therapy Program | Experimental | Other: Robotic Therapy ProgramThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic stroke survivor (at least 6 months post stroke)
- Completed all outpatient stroke rehabilitation
- Upper limb recovery between stage 3 to 5 (out of 7) in the arm on the Chedoke McMaster Stroke Assessment (CMSA) Stages of Motor Impairment (Gowland et. al, 1993)
- Able to attend 3 - 4 visits per week at the clinic for 12 weeks with a 4 week follow up
- Able to tolerate up to 1 hour of activity in seated position
Key exclusion criteria (2 listed)
- Significant upper limb neurological or musculoskeletal condition other than stroke
- Shoulder subluxation or significant pain that limits active mobility treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Therapy Program | Other | Robotic Therapy Program |
Primary outcome
Change from baseline mean movement velocity of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
Time frame: 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)
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.
Change from baseline movement smoothness of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
Time frame: 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)
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.
Change from baseline movement error of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
Time frame: 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)
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.
Change from baseline range of motion of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
Time frame: 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)
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.
6 secondary outcomes
Fugl-Meyer Assessment - Upper Extremity (FMA - UE)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Administered in last visit of 2nd A Phase (12th week)
Outpatient Service Satisfaction Survey
Time frame: Administered in last visit of 2nd A Phase (12th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- BackgroundLu 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
- Background: PubMed 22580169Graham 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.
- BackgroundBarlow, DH and Hersen, M. Single case experimental designs: Strategies for studying behaviour change. New York: Pergamon Press, 1984.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalie H Wang, PhD principal investigator
University Health Network/University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Therapy Program in people with Stroke, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline mean movement velocity of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321290, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.