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

August 21, 2018 updated by: Clare Maguire, Technical University of Bern

Replacing Canes With an Elasticated Orthotic-garment 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Device: Cane
Assistive walking device
ACTIVE_COMPARATOR: 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.
Device: Elasticated worn orthotic-garment
Assistive walking device -elasticated worn orthotic garment
Other Names:
  • TheraTogs (product name)
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Post intervention up to 28 weeks (on average 21.5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Bern

Collaborators

Rehab Basel
Bildungszentrum Gesundheit Basel-Stadt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2014

Primary Completion (ACTUAL)

October 15, 2014

Study Completion (ACTUAL)

January 30, 2015

Study Registration Dates

First Submitted

August 11, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUBern

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Cane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe