Stroke Gait RehabilitationNCT01366729
Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs
A study testing TheraTogs and Cane walking in people with Stroke Gait Rehabilitation, run by Technical University of Bern at 3 sites in Switzerland.
Trial summary
Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Gait Rehabilitation
- What is being tested?
- TheraTogs and Cane walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Nov 2011to Aug 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
- patients with hemiplegia following a first unilateral stroke
- will score at least level 3 on the Functional Ambulation Category (FAC) (able to walk unaided on even ground but requiring verbal prompts and stand-by help without body contact)
- must have been independent walkers prior to insult without walking aids
- Subjects will have a Mini Mental State score of 22 or above
Who cannot join
- orthopaedic or other neurological conditions that could limit walking ability
- no gross visuospatial or visual field deficits
- no medical contraindications to walking
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
RehaClinic Bad Zurzach
Bad Zurzach, Canton of Aargau
Felix Platterspital
Basel, Canton of Basel-City, 4012
Kantonsspital Luzern
Lucerne
About this study
Official title: How to Improve Walking, Balance and Social Participation Following Stroke: a Comparison of Cane Walking to an Orthosis TheraTogs in Early Post-stroke Gait Rehabilitation. A Multi-centred, Single Blind,Randomized Control Trial.
Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability.
Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side influence ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" ( elastic corset supporting hemiplegic side) significantly increases hemiplegic muscle activity during gait.
Read more
To date no clinical studies have investigated the long term effects of these techniques on gait recovery following stroke.
This study aims to determine if advances in the understanding of cortical plasticity and its relation to functional recovery following stroke can be applied to clinical gait rehabilitation to improve long term outcomes.
Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and inhibit balance reactions. In the long term this causes poorer walking ability and balance and consequently reduced social participation.
Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and facilitate balance reactions. In the long term this improves walking ability and balance leading to increased social independence and participation.
Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke patients Intervention When subjects can walk unaided on even ground whilst requiring verbal prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure. Cane walking with cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented.The intervention will continue for five weeks or until patients have reached FAC 5 (independent walkers on all surfaces).
Measures: the day before intervention begin, the day after intervention completion (max 5 weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed "up and go" test Secondary outcomes surface EMG of hemiplegic lower extremity musculature, temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.
Results Significance levels will be 5% with 95% CI's. ITT analyses will be performed. Descriptive statistics will be presented. Relevant co-variables will be identified and analysed. Discussion This study could have significant implications for the clinical practice of gait rehabilitation after stroke in particular the effect and appropriate use of walking aids
- Conditions
- Stroke Gait Rehabilitation
- Being tested
- TheraTogs, Cane walking
- Keywords
- hemiplegia, walking, canes, TheraTogs, EMG, balance, Timed up and go
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraTogsDevice
Orthosis facilitating hemiplegic hip extensor and abductor activity. Worn daily from dressing in the morning to undressing at night. May be removed during therapy or afternoon sleep.
Cane walkingDevice
All walking activities must take place with cane from waking until sleeping
| Study group | Role | What they receive |
|---|---|---|
| TheraTogs | Experimental | Not described Receives: Device: TheraTogs |
| Cane walking | Active comparator | Not described Receives: Device: Cane walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed "up and go" test
Measured: the day after intervention completion (max 5 weeks)
Secondary outcomes (7)
surface EMG of hemiplegic lower extremity musculature
peak surface EMG of gluteus maximus and medius
Measured: the day after intervention completion (max 5 weeks)
temporo-spatial gait parameters
Measured: the day after intervention completion (max 5 weeks)
hip kinematics
hemiplegic hip kinematic measurements in sagital and frontal planes
Measured: the day after intervention completion (max 5 weeks)
Dynamic balance
Sway Star
Measured: the day after intervention completion (max 5 weeks)
The Stroke Impact Scale
Measured: the day after intervention completion (max 5 weeks)
EMG activation patterns of hemiplegic leg musculature
EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior
Measured: 1 day post intervention completion (max 5 weeks)
Accelerometer Activity Monitoring
The accelerometer (Aipermon® GmbH, Germany) will be attached to the patient's belt and positioned above the left hip. Patients will wear the device during waking hours during intervention time. The accelerometer will be attached after dressing in the morning and only taken off for showering, bathing and sleeping. In the statistical analysis a day starts at 24.00 o'clock and ends at 23.59 o'clock the same day. Mean activity per day will be calculated
Measured: Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Unable to recruite enough subjects to reach statistical power
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 Stroke Gait RehabilitationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Clare Maguire, Technical University of Bern
- Investigators
- Clare C Maguire, MSc PT, Principal investigator, Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366729
- Sponsor's protocol ID
- TTvS_13DPD6_134993_BFHBZG
- Status last verified
- Dec 2022
- First submitted
- 2 Jun 2011
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Maguire C, Sieben JM, Erzer F, Goepfert B, Frank M, Ferber G, Jehn M, Schmidt-Trucksass A, de Bie RA. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial. BMC Neurol. 2012 Mar 30;12:18. doi: 10.1186/1471-2377-12-18.
PubMed 22462692
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Improve Walking, Balance and Social Participation Following Stroke: a Comparison of Cane Walking to an Orthosis TheraTogs in Early Post-stroke Gait Rehabilitation. A Multi-centred, Single Blind,Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01366729
- Acronym / sponsor ID
- TTvS_13DPD6_134993_BFHBZG
- Conditions
- Stroke Gait Rehabilitation
- Keywords
- hemiplegia, walking, canes, TheraTogs, EMG, balance, Timed up and go
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruite enough subjects to reach statistical power
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Technical University of BernUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Nov 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Jun 2011 (estimated)
- 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.
Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability.
Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side influence ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" ( elastic corset supporting hemiplegic side) significantly increases hemiplegic muscle activity during gait.
To date no clinical studies have investigated the long term effects of these techniques on gait recovery following stroke.
This study aims to determine if advances in the understanding of cortical plasticity and its relation to functional recovery following stroke can be applied to clinical gait rehabilitation to improve long term outcomes.
Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and inhibit balance reactions. In the long term this causes poorer walking ability and balance and consequently reduced social participation.
Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and facilitate balance reactions. In the long term this improves walking ability and balance leading to increased social independence and participation.
Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke patients Intervention When subjects can walk unaided on even ground whilst requiring verbal prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure. Cane walking with cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented.The intervention will continue for five weeks or until patients have reached FAC 5 (independent walkers on all surfaces).
Measures: the day before intervention begin, the day after intervention completion (max 5 weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed "up and go" test Secondary outcomes surface EMG of hemiplegic lower extremity musculature, temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.
Results Significance levels will be 5% with 95% CI's. ITT analyses will be performed. Descriptive statistics will be presented. Relevant co-variables will be identified and analysed. Discussion This study could have significant implications for the clinical practice of gait rehabilitation after stroke in particular the effect and appropriate use of walking aids
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TheraTogs | Experimental | Device: TheraTogs |
| Cane walking | Active comparator | Device: Cane walking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with hemiplegia following a first unilateral stroke
- will score at least level 3 on the Functional Ambulation Category (FAC) (able to walk unaided on even ground but requiring verbal prompts and stand-by help without body contact)
- must have been independent walkers prior to insult without walking aids
- Subjects will have a Mini Mental State score of 22 or above
Key exclusion criteria (3 listed)
- orthopaedic or other neurological conditions that could limit walking ability
- no gross visuospatial or visual field deficits
- no medical contraindications to walking
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 |
|---|---|---|
| TheraTogsOrthosis facilitating hemiplegic hip extensor and abductor activity. Worn daily from dressing in the morning to undressing at night. May be removed during therapy or afternoon sleep. | Device | TheraTogs |
| Cane walkingAll walking activities must take place with cane from waking until sleeping | Device | Cane walking |
Primary outcome
Timed "up and go" test
Time frame: the day after intervention completion (max 5 weeks)
7 secondary outcomes
surface EMG of hemiplegic lower extremity musculature
Time frame: the day after intervention completion (max 5 weeks)
temporo-spatial gait parameters
Time frame: the day after intervention completion (max 5 weeks)
hip kinematics
Time frame: the day after intervention completion (max 5 weeks)
Dynamic balance
Time frame: the day after intervention completion (max 5 weeks)
The Stroke Impact Scale
Time frame: the day after intervention completion (max 5 weeks)
EMG activation patterns of hemiplegic leg musculature
Time frame: 1 day post intervention completion (max 5 weeks)
Accelerometer Activity Monitoring
Time frame: Immediately post intervention
Results and safety
The study was stopped early (reason given: Unable to recruite enough subjects to reach statistical power). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 22462692Maguire C, Sieben JM, Erzer F, Goepfert B, Frank M, Ferber G, Jehn M, Schmidt-Trucksass A, de Bie RA. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial. BMC Neurol. 2012 Mar 30;12:18. doi: 10.1186/1471-2377-12-18.
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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.
Clare C Maguire, MSc PT principal investigator
Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraTogs and Cane walking in people with Stroke Gait Rehabilitation, run by Technical University of Bern at 3 sites in Switzerland.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Unable to recruite enough subjects to reach statistical power). Results are not available in the source record.
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?
Timed "up and go" test (time frame: the day after intervention completion (max 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 NCT01366729, 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 29 Dec 2022.