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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642444
• Other study ID #: TUBern
• Status: Completed
• Phase: N/A
• Start date: January 8, 2014
• Est. completion date: January 30, 2015

Study information

• Verified date: August 2018
• Source: Technical University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 30, 2015
• Est. primary completion date: October 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Cane
Assistive walking device
• Elasticated worn orthotic-garment
Assistive walking device -elasticated worn orthotic garment

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Technical University of Bern	Bildungszentrum Gesundheit Basel-Stadt, Rehab Basel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Post intervention up to 28 weeks (on average 21.5 weeks)
Secondary	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)	Post intervention up to 28 weeks (on average 21.5 weeks)