Clinical trial NCT02969967: Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke
Official title: Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke: a Multiple Single Subject Design Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
upper extremity
orthosis
SaeboFlex
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity recovery for people in the early phases of rehabilitation post stroke. The objectives of the study are:

1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity function, strength, movement, spasticity and self-perceived occupational performance, in addition to conventional therapy, with continued use immediately after discharge from inpatient stroke rehabilitation and while waiting for outpatient occupational therapy services
2. to explore the relationship between the participants' level of self-efficacy and use of the SaeboFlex orthosis in the home environment
3. to explore the participants' experience of use of the SaeboFlex orthosis in the home environment.

Detailed description: Although intensive and repetitive use of the paretic upper extremity has been shown to improve upper extremity outcomes post stroke, few therapeutic approaches allow those with moderate to severe upper extremity impairment to independently participate in repetitive grasp and release activities. The SaeboFlex orthosis is a dynamic wrist-hand orthosis that assists with finger and thumb extension after functional grasping with the paretic hand and therefore may allow those with more affected upper extremities post stroke to participate in repetitive grasp and release activities that they otherwise would be unable to do. More research is required on the effectiveness of this orthosis in improving upper extremity recovery post stroke especially when used at home as a continuation of therapy received during inpatient rehabilitation. It has been suggested that guided home rehabilitation programs can improve the ability of stroke survivors to be more independent in their activities of daily living. This study is a mixed methods study combining a quantitative single subject ABA design and qualitative post study individual interviews to first capture quantitative information on the effectiveness of the SaeboFlex intervention and then qualitative information that will build on and further explain the quantitative data. Three participants who are using a SaeboFlex orthosis as part of their upper extremity rehabilitation program will be recruited from an inpatient stroke rehabilitation unit as they are being discharged from inpatient rehabilitation and will be seen by the principal investigator in their homes for 1 hour 3 times a week for 2 weeks and then once a week for 6 weeks while they are on the waiting list for outpatient occupational therapy services. The intervention will follow a set protocol of grasp-release activities using the SaeboFlex orthosis for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis, both of which will be graded to provide optimal upper extremity challenge throughout the intervention period. Repeated baseline assessments will be completed by a trained research assistant, in the participants' homes, within one week of discharge from inpatient stroke rehabilitation and will be repeated after 4 and 8 weeks of intervention, followed by individual interviews in the participants' homes.

Eligibility criteria: Inclusion Criteria:

* adults aged 18 or over who have had a first stroke within the past 6 months
* admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and are being discharged to home locations within the city of Winnipeg
* fit with and started using a custom SaeboFlex orthosis as an inpatient at Riverview Health Centre after having met the active and passive movement criteria required to use the SaeboFlex orthosis
* referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg, Canada) for ongoing upper extremity rehabilitation using a SaeboFlex orthosis
* able to commit to the time requirements of the study
* have a premorbid fully functional upper extremity
* able to speak and understand English
* able to follow multistep commands and understand the purpose and required use of the orthosis
* able to stand for at least 10 minutes
* have 3 times per week access to a caregiver to assist with donning the orthosis at home if required

Exclusion Criteria:

* Chedoke McMaster Stroke Assessment, Impairment Inventory (Shoulder Pain section) score of 1-3
* score of 3 or more on the Modified Ashworth Scale for elbow, wrist or finger flexors
* swan neck deformities or contractures of the fingers or wrist of the paretic upper extremity
* history of skin breakdown on the paretic upper extremity or a score of less than 6 out of 12 on the Sensation Section of the Fugl-Meyer Upper Extremity Assessment
* significant cognitive impairment as determined by a score of 21 or less on the Montreal Cognitive Assessment
* able to fully extend fingers 10 times in a position of maximal shoulder flexion and elbow extension with a neutral wrist

Primary outcomes:
measure: Arm Activity Measure (ArmA)
timeFrame: Change from baseline upper extremity function to 4 and 8 weeks
measure: Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7)
timeFrame: Change from baseline upper extremity function to 4 and 8 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
timeFrame: Change from baseline upper extremity impairment to 4 and 8 weeks
measure: Stroke Impact Scale (SIS)
timeFrame: Change from baseline perception of recovery to 4 and 8 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from baseline spasticity to 4 and 8 weeks
measure: Hand Grip Strength (measured using dynamometry)
timeFrame: Change from baseline grip strength to 4 and 8 weeks
measure: Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: Change from baseline self-efficacy to 4 and 8 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline perception of occupational performance to 4 and 8 weeks
Other outcomes:
measure: Individual interviews
timeFrame: 8 weeks
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Brenda L Semenko, BMR (OT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
citation: Waddell KJ, Birkenmeier RL, Moore JL, Hornby TG, Lang CE. Feasibility of high-repetition, task-specific training for individuals with upper-extremity paresis. Am J Occup Ther. 2014 Jul-Aug;68(4):444-53. doi: 10.5014/ajot.2014.011619.
citation: Butler A, Blanton S, Rowe V, Wolf S. Attempting to improve function and quality of life using the FTM Protocol: case report. J Neurol Phys Ther. 2006 Sep;30(3):148-56. doi: 10.1097/01.npt.0000281952.93934.6b.
citation: Legg L, Langhorne P; Outpatient Service Trialists. Rehabilitation therapy services for stroke patients living at home: systematic review of randomised trials. Lancet. 2004 Jan 31;363(9406):352-6. doi: 10.1016/S0140-6736(04)15434-2.