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Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cane
Elasticated worn orthotic-garment
Sponsored by
Technical University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic stroke (> six months since last stroke)
  • 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:

  • Patients at risk of falling identified as a Berg Balance Score ≤42/56

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Phase A cane walking (assistive walking-device a cane)

    Phase B elasticated orthotic-garment - TheraTogs

    Phase C follow-Up

    Arm Description

    9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
    Change of gait function between phases A (baseline) and Phase B (Intervention)

    Secondary Outcome Measures

    Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)
    Change of trunk-sway at body center-of-mass during walking measured as Total-Angle-Area(TAA°) in frontal and sagittal-planes measured with a gyroscope "Sway Star" between phases A (baseline) and Phase B (Intervention)

    Full Information

    First Posted
    August 11, 2018
    Last Updated
    August 21, 2018
    Sponsor
    Technical University of Bern
    Collaborators
    Bildungszentrum Gesundheit Basel-Stadt, Rehab Basel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03642444
    Brief Title
    Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
    Official Title
    Replacing Canes With an Elasticated Orthotic-garment in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 8, 2014 (Actual)
    Primary Completion Date
    October 15, 2014 (Actual)
    Study Completion Date
    January 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Technical University of Bern
    Collaborators
    Bildungszentrum Gesundheit Basel-Stadt, Rehab Basel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to investigate the effect of an elasticated orthotic garment "Thera Togs" on walking ability and balance in currently cane using chronic stroke subjects (minimum 6 months post stroke) using a series of N-of-1 Trials.
    Detailed Description
    Aim: To investigate the effect of replacing canes with an elasticated orthotic-garment on gait and balance in chronic stroke subjects. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    stroke, hemiplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    N-of-1 series
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase A cane walking (assistive walking-device a cane)
    Arm Type
    Active Comparator
    Arm Description
    9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane.
    Arm Title
    Phase B elasticated orthotic-garment - TheraTogs
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Phase C follow-Up
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Cane
    Intervention Description
    Assistive walking device
    Intervention Type
    Device
    Intervention Name(s)
    Elasticated worn orthotic-garment
    Other Intervention Name(s)
    TheraTogs (product name)
    Intervention Description
    Assistive walking device -elasticated worn orthotic garment
    Primary Outcome Measure Information:
    Title
    Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
    Description
    Change of gait function between phases A (baseline) and Phase B (Intervention)
    Time Frame
    Post intervention up to 28 weeks (on average 21.5 weeks)
    Secondary Outcome Measure Information:
    Title
    Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)
    Description
    Change of trunk-sway at body center-of-mass during walking measured as Total-Angle-Area(TAA°) in frontal and sagittal-planes measured with a gyroscope "Sway Star" between phases A (baseline) and Phase B (Intervention)
    Time Frame
    Post intervention up to 28 weeks (on average 21.5 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic stroke (> six months since last stroke) 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: Patients at risk of falling identified as a Berg Balance Score ≤42/56

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33218513
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials

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