Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
NCT ID: NCT03642444
Last Updated: 2018-08-22
Study Results
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Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2014-01-08
2015-01-30
Brief Summary
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Detailed Description
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Design Experimental, multiple baseline N-of-1 series with an ABC design with randomised period duration.
Participants Four cane using chronic stroke subjects. Interventions Phase A (9-12 weeks) usual cane-walking to establish baseline values; Phase B (9-19 weeks) intervention: orthotic-garment worn throughout the day with maximal cane reduction; Phase C (9-10 weeks) individually determined follow-up: either no walking-aid, orthotic-garment or cane.
Weekly measurement of Outcome Measures for gait and balance function
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase A cane walking (assistive walking-device a cane)
9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane.
Cane
Assistive walking device
Phase B elasticated orthotic-garment - TheraTogs
9-19 weeks : assistive walking-device which is an elasticated orthotic-garment worn throughout the day (product name TheraTogs). Cane use maximally reduced during his period.
Elasticated worn orthotic-garment
Assistive walking device -elasticated worn orthotic garment
Phase C follow-Up
9-10 weeks individually determined follow-up: subjects determine whether they walk independently (without assistive device) or with the elasticated orthotic-garment (TheraTogs) or with a cane.
No interventions assigned to this group
Interventions
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Cane
Assistive walking device
Elasticated worn orthotic-garment
Assistive walking device -elasticated worn orthotic garment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Independent cane walkers. Subjects usually use canes to walk inside (this could be intermittent changing from cane to holding furniture etc.) and always when outside
* A Mini Mental Score of 22 or above.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bildungszentrum Gesundheit Basel-Stadt
UNKNOWN
Rehab Basel
OTHER
Technical University of Bern
OTHER
Responsible Party
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Clare Maguire
Principle Investigator
References
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Maguire CC, Sieben JM, Lutz N, van der Wijden G, Scheidhauer H, de Bie R. Replacing canes with an elasticated orthotic-garment in chronic stroke patients - The influence on gait and balance. A series of N-of-1 trials. J Bodyw Mov Ther. 2020 Oct;24(4):203-214. doi: 10.1016/j.jbmt.2020.06.006. Epub 2020 Jul 30.
Other Identifiers
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TUBern
Identifier Type: -
Identifier Source: org_study_id
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