Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
1 other identifier
interventional
4
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2015
CompletedFirst Submitted
Initial submission to the registry
August 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedAugust 22, 2018
August 1, 2018
9 months
August 11, 2018
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)
Post intervention up to 28 weeks (on average 21.5 weeks)
Study Arms (3)
Phase A cane walking (assistive walking-device a cane)
ACTIVE COMPARATOR9-12 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 COMPARATOR9-19 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 INTERVENTION9-10 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.
Interventions
Assistive walking device -elasticated worn orthotic garment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients at risk of falling identified as a Berg Balance Score ≤42/56
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technical University of Bernlead
- Bildungszentrum Gesundheit Basel-Stadtcollaborator
- Rehab Baselcollaborator
Related Publications (1)
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.
PMID: 33218513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 11, 2018
First Posted
August 22, 2018
Study Start
January 8, 2014
Primary Completion
October 15, 2014
Study Completion
January 30, 2015
Last Updated
August 22, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share