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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

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ClinicalTrials.gov Identifier: NCT03642444
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Bildungszentrum Gesundheit Basel-Stadt
Rehab Basel
Information provided by (Responsible Party):
Clare Maguire, Technical University of Bern

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: Cane Device: Elasticated worn orthotic-garment Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: N-of-1 series
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 8, 2014
Actual Primary Completion Date : October 15, 2014
Actual Study Completion Date : January 30, 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: Cane
Assistive walking device
Active Comparator: 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.
 Device: Elasticated worn orthotic-garment
Assistive walking device -elasticated worn orthotic garment
Other Name: TheraTogs (product name)
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks) [ Time Frame: Post intervention up to 28 weeks (on average 21.5 weeks) ]
    Change of gait function between phases A (baseline) and Phase B (Intervention)


Secondary Outcome Measures :
  1. Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks) [ Time Frame: Post intervention up to 28 weeks (on average 21.5 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clare Maguire, Principle Investigator, Technical University of Bern
ClinicalTrials.gov Identifier: NCT03642444    
Other Study ID Numbers: TUBern
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Clare Maguire, Technical University of Bern:
stroke
hemiplegia
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases