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

NCT02969967 | Completed

• 1 other identifier: H2016:285
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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. 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. 2.to explore the relationship between the participants' level of self-efficacy and use of the SaeboFlex orthosis in the home environment
3. 3.to explore the participants' experience of use of the SaeboFlex orthosis in the home environment.

Conditions

Stroke

Keywords

rehabilitation; upper extremity; orthosis; SaeboFlex

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Individual interviews

  8 weeks

Study Arms (1)

SaeboFlex

EXPERIMENTAL

Use of the SaeboFlex orthosis for a set protocol of grasp-release activities

Device: SaeboFlex

Interventions

SaeboFlex DEVICE

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.

Also known as: functional dynamic orthosis

SaeboFlex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (4)

• 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.

  PMID: 20424192 BACKGROUND

• 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.

  PMID: 25005508 BACKGROUND

• 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.

  PMID: 17029658 BACKGROUND

• 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.

  PMID: 15070563 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brenda L Semenko, BMR (OT)

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)