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NCT Number: NCT03642444

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cane

Device

Assistive walking device

Elasticated worn orthotic-garment

Device

Assistive walking device -elasticated worn orthotic garment

Other names: TheraTogs (product name)

Primary outcomes

  1. Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)

    Time frame: Post intervention up to 28 weeks (on average 21.5 weeks)

    Change of gait function between phases A (baseline) and Phase B (Intervention)

Secondary outcomes

  1. Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)

    Time frame: Post intervention up to 28 weeks (on average 21.5 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)

Sponsors and collaborators

Lead sponsor

Technical University of Bern

Other

Collaborators

  • Bildungszentrum Gesundheit Basel-Stadt
  • Rehab Basel

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 22, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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