Replacing Canes With an Elasticated Orthotic-garment in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
| Registry | NCT03642444 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, sequential, masking: none, treatment |
| Enrollment | 4 (Actual) |
| Sponsor | Technical University of Bern (Other); collaborators: Bildungszentrum Gesundheit Basel-Stadt, Rehab Basel |
| Conditions | Stroke |
| Interventions | Cane, Elasticated worn orthotic-garment (Device) |
| Dates | start 2014-01-08, primary completion 2014-10-15, completion 2015-01-30, first posted 2018-08-22, last updated 2018-08-22 |
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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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Phase A cane walking (assistive walking-device a cane) | Active comparator | Device: 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 | Active comparator | Device: 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. |
| Phase C follow-Up | No intervention | 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. |
Sex: All, ages: 18 Years to any
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