StrokeNCT03642444
Replacing Canes With an Elasticated Orthosis in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
A study testing Cane and Elasticated worn orthotic-garment in people with Stroke, run by Technical University of Bern.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cane and Elasticated worn orthotic-garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2014to 30 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients at risk of falling identified as a Berg Balance Score ≤42/56
About this study
Official 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
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.
Read the 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
- Conditions
- Stroke
- Being tested
- Cane, Elasticated worn orthotic-garment
- Keywords
- stroke, hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaneDevice
Assistive walking device
Elasticated worn orthotic-garmentDevice
Also called TheraTogs (product name)
Assistive walking device -elasticated worn orthotic garment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 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. Receives: Device: Elasticated worn orthotic-garment |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: Post intervention up to 28 weeks (on average 21.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start8 Jan 2014
- Primary completion15 Oct 2014
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- N-of-1 series
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bildungszentrum Gesundheit Basel-Stadt, Rehab Basel
- Responsible party
- Principal investigator, Clare Maguire, Technical University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642444
- Sponsor's protocol ID
- TUBern
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33218513
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03642444
- Acronym / sponsor ID
- TUBern
- Conditions
- Stroke
- Keywords
- stroke, hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Technical University of BernUniversity, hospital or other
- Collaborators
- Bildungszentrum Gesundheit Basel-Stadt, Rehab Basel
- Study start
- 8 Jan 2014 (actual)
- Primary completion
- 15 Oct 2014 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- N-of-1 series
| Arm | Type | Receives |
|---|---|---|
| Phase A cane walking (assistive walking-device a cane) | Active comparator | Device: Cane9-12 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 | Device: Elasticated worn orthotic-garment9-19 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients at risk of falling identified as a Berg Balance Score ≤42/56
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaneAssistive walking device | Device | Phase A cane walking (assistive walking-device a cane) |
| Elasticated worn orthotic-garmentAlso: TheraTogs (product name)Assistive walking device -elasticated worn orthotic garment | Device | Phase B elasticated orthotic-garment - TheraTogs |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 33218513Maguire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cane and Elasticated worn orthotic-garment in people with Stroke, run by Technical University of Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03642444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.