NCT03642444

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Technical University of Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Cane	Assistive walking device
DEVICE	Elasticated worn orthotic-garment	Assistive walking device -elasticated worn orthotic garment

Timeline

• Start date: 2014-01-08
• Primary completion: 2014-10-15
• Completion: 2015-01-30
• First posted: 2018-08-22
• Last updated: 2018-08-22

Regulatory

• FDA-regulated device study