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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Cane; Device: Elasticated worn orthotic-garment

• Registration Number: NCT03642444
• Lead Sponsor: Technical University of Bern

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

Study Timeline

• Study Start: 2014-01-08
• Primary Completion: 2014-10-15
• Study Completion: 2015-01-30
• Status Verified: 2018-08
• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-21
• Last Update Submitted: 2018-08-21
• Study First Posted: 2018-08-22
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase A cane walking (assistive walking-device a cane)	Cane	9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane.
Phase B elasticated orthotic-garment - TheraTogs	Elasticated worn orthotic-garment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)