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

NCT ID: NCT03642444

Last Updated: 2018-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-08

Study Completion Date

2015-01-30

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

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

N-of-1 series
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Cane

Intervention Type DEVICE

Assistive walking device

Phase B elasticated orthotic-garment - TheraTogs

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.

Group Type ACTIVE_COMPARATOR

Elasticated worn orthotic-garment

Intervention Type DEVICE

Assistive walking device -elasticated worn orthotic garment

Phase C follow-Up

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cane

Assistive walking device

Intervention Type DEVICE

Elasticated worn orthotic-garment

Assistive walking device -elasticated worn orthotic garment

Intervention Type DEVICE

Other Intervention Names

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TheraTogs (product name)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bildungszentrum Gesundheit Basel-Stadt

UNKNOWN

Sponsor Role collaborator

Rehab Basel

OTHER

Sponsor Role collaborator

Technical University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Clare Maguire

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33218513 (View on PubMed)

Other Identifiers

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TUBern

Identifier Type: -

Identifier Source: org_study_id

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