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 Bern

Status: Completed

Conditions: Stroke

Treatments: Device: Elasticated worn orthotic-garment; Device: Cane

Study type: Interventional

Funder types: Other

Identifiers

NCT03642444

TUBern

Details and patient eligibility

About

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.

Full 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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Phase A cane walking (assistive walking-device a cane)

Active Comparator group

Description:

9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane.

Treatment:

Device: Cane

Phase B elasticated orthotic-garment - TheraTogs

Active Comparator group

Description:

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.

Treatment:

Device: Elasticated worn orthotic-garment

Phase C follow-Up

No Intervention group

Description:

9-10 weeks individually determined follow-up: subjects determine whether they walk independently (without assistive device) or with the elasticated orthotic-garment (TheraTogs) or with a cane.