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| Name | Class |
|---|---|
| Bildungszentrum Gesundheit Basel-Stadt | UNKNOWN |
| Rehab Basel | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A cane walking (assistive walking-device a cane) | Active Comparator | 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 | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cane | Device | Assistive walking device |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33218513 | Derived | Maguire CC, Sieben JM, Lutz N, van der Wijden G, Scheidhauer H, de Bie R. Replacing canes with an elasticated orthotic-garment in chronic stroke patients - The influence on gait and balance. A series of N-of-1 trials. J Bodyw Mov Ther. 2020 Oct;24(4):203-214. doi: 10.1016/j.jbmt.2020.06.006. Epub 2020 Jul 30. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002183 | Canes |
| ID | Term |
|---|---|
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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N-of-1 series
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| Elasticated worn orthotic-garment |
| Device |
Assistive walking device -elasticated worn orthotic garment |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |