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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03642444

Enrollment

Registered

2018-08-22

Start date

2014-01-08

Completion date

2015-01-30

Last updated

2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, hemiplegia

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

Interventions

DEVICECane

Assistive walking device

DEVICEElasticated worn orthotic-garment

Assistive walking device -elasticated worn orthotic garment

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

N-of-1 series

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)	Post intervention up to 28 weeks (on average 21.5 weeks)	Change of gait function between phases A (baseline) and Phase B (Intervention)

Secondary

Measure	Time frame	Description
Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)	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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026