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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Cane
* Device: Elasticated worn orthotic-garment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: N-of-1 series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phase A cane walking (assistive walking-device a cane)<br>9-12 weeks usual cane-walking to establish baseline values. Patients walk with their usual assistive-walking device - a cane. | Device: Cane<br>* Assistive walking device<br>|
| Active Comparator: Phase B elasticated orthotic-garment - TheraTogs<br>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. | Device: Elasticated worn orthotic-garment<br>* Assistive walking device -elasticated worn orthotic garment<br>* Other names: TheraTogs (product name);|
| No Intervention: Phase C follow-Up<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, hemiplegia