Robotic Therapy Program for the Arm After Stroke

University Health Network, Toronto

Status: Completed

Conditions: Stroke

Treatments: Other: Robotic Therapy Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05321290

14-8702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Robotic Therapy Program

Experimental group

Description:

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.

Treatment:

Other: Robotic Therapy Program