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

Technical University of Bern4 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

CaneDEVICE

Assistive walking device

Elasticated worn orthotic-garmentDEVICE

Assistive walking device -elasticated worn orthotic garment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Post intervention up to 28 weeks (on average 21.5 weeks)

Secondary Outcomes

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)

Time frame: Post intervention up to 28 weeks (on average 21.5 weeks)

Data from ClinicalTrials.gov

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