Clinical trial NCT05321290: Robotic Therapy Program for the Arm After Stroke
Official title: Evaluation of an Outpatient Upper Limb Robotic Therapy Program for Older Adult Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Upper limb
Chronic stroke
Robotics
Older adult
Goal setting
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Drummond Foundation
First posted: 2022-04-11
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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:

1. To evaluate the efficacy of the program in improving upper limb movement function and goal achievement in older adult chronic stroke survivors
2. To evaluate older adult chronic stroke survivor satisfaction with the rehabilitation program (e.g. overall therapy program, robotic system, service delivery)
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Significant upper limb neurological or musculoskeletal condition other than stroke
* Shoulder subluxation or significant pain that limits active mobility treatment

Primary outcomes:
measure: Change from baseline mean movement velocity of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
timeFrame: 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)
measure: Change from baseline movement smoothness of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
timeFrame: 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)
measure: Change from baseline movement error of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
timeFrame: 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)
measure: Change from baseline range of motion of affected arm after 8 weeks of therapy as assessed by metric derived from robot sensor data
timeFrame: 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:
measure: Fugl-Meyer Assessment - Upper Extremity (FMA - UE)
timeFrame: 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)
measure: Action Arm Research Test (ARAT)
timeFrame: 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)
measure: Goal Attainment Scaling (GAS)
timeFrame: 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)
measure: Motor Activity Log (MAL)
timeFrame: 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)
measure: Quebec User Evaluation of Satisfaction with Technology (QUEST) 2.0 Scale
timeFrame: Administered in last visit of 2nd A Phase (12th week)
measure: Outpatient Service Satisfaction Survey
timeFrame: Administered in last visit of 2nd A Phase (12th week)
Other outcomes:
measure: Open-ended interview questions
timeFrame: Administered in last visit of 2nd A phase (12th week)
measure: Summative evaluation of program feasibility (yes/no)
timeFrame: Data recorded throughout the entire study, and through study completion for each participant (16 weeks/participant).
Locations:
Study officials:
affiliation: University Health Network/University of Toronto
name: Rosalie H Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: Barlow, DH and Hersen, M. Single case experimental designs: Strategies for studying behaviour change. New York: Pergamon Press, 1984.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.