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Search / Trial NCT02969967

Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke

Launched by UNIVERSITY OF MANITOBA · Nov 17, 2016

Trial Information

Current as of May 05, 2025

Completed

Keywords

Rehabilitation Upper Extremity Orthosis Saebo Flex

ClinConnect Summary

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 other...

Gender

ALL

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

About University Of Manitoba

The University of Manitoba, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive expertise in medical research, public health, and community engagement to conduct rigorous and ethical clinical studies. The institution aims to translate scientific findings into practical applications that enhance patient care and improve health outcomes. Committed to fostering a culture of excellence and integrity, the University of Manitoba prioritizes participant safety and scientific validity in all its clinical research endeavors.

Locations

Winnipeg, Manitoba, Canada

Patients applied

0 patients applied

Trial Officials

Brenda L Semenko, BMR (OT)

Principal Investigator

University of Manitoba

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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