NCT02969967|Completed
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Sponsor study identifier
interventional
2
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
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.
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
November 10, 2016
Actual (reported)November 21, 2016
Actual (reported)June 2017
Actual (reported)June 2017
Actual (reported)Arm Activity Measure (ArmA)
The Arm Activity Measure (ArmA) is a self-report tool designed for use with upper extremity spasticity management interventions. The ArmA was chosen because it provides a comprehensive assessment at the activity level of both active and passive upper extremity function; it is comprised of an 8 item passive function subscale and a 13 item active function subscale. Both subscales have been found to have high internal consistency and test-retest reliability.
Change from baseline upper extremity function to 4 and 8 weeks
Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7)
The Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7) is a commonly used upper extremity functional assessment post stroke. It is comprised of seven bilateral functional tasks and has been found to have excellent test-retest and inter-rater reliability as well as internal consistency.
Change from baseline upper extremity function to 4 and 8 weeks
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Change from baseline upper extremity impairment to 4 and 8 weeks
Stroke Impact Scale (SIS)
Change from baseline perception of recovery to 4 and 8 weeks
Modified Ashworth Scale (MAS)
Change from baseline spasticity to 4 and 8 weeks
Hand Grip Strength (measured using dynamometry)
Change from baseline grip strength to 4 and 8 weeks
Stroke Self-Efficacy Questionnaire (SSEQ)
Change from baseline self-efficacy to 4 and 8 weeks
Individual interviews
8 weeks
Use of the SaeboFlex orthosis for a set protocol of grasp-release activities
Use of the SaeboFlex orthosis for a set protocol of grasp-release activities for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis for 8 weeks. Will occur in participants' homes after discharge from inpatient rehabilitation with visit from principal investigator to progress program for 1 hour 3 times a week for the first 2 weeks and then once a week for 6 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
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.
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.
Brenda L Semenko, BMR (OT)
University of Manitoba
2 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2016
First Posted
November 21, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Reaching in Stroke 3rd Phase
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)Last Updated
December 2, 2017
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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