StrokePhase 4NCT02114736
Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
A Phase 4 study testing Tenotomy of the proximal rectus femoris tendon and Botulinum Toxin injection in the rectus femoris muscle in people with Stroke and Spasticity, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Spasticity
- What is being tested?
- Tenotomy of the proximal rectus femoris tendon and Botulinum Toxin injection in the rectus femoris muscle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to Dec 2017
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke lasting for more than 6 months
- stiff knee gait
- rectus femoris spasticity (> Ashworth 2)
- transient improvement with previous botulinum toxine A injection in the rectus femoris
- stiff knee gait improved after rectus femoris diagnostic motor nere block
- able to walk on treadmill
Who cannot join
- pregnant women
- botulinum toxin A injections in the rectus femoris < 6 months
- previous surgery for stiff knee gait
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Mont-Godinne
Yvoir, 5530
Thierry Deltombe, M.D., + 32 81 42 37 72, thierry.deltombe@uclouvain.be
About this study
Official title: A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. However, the botulinum toxin A effect is transient necessitating repeated injections.
The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison with botulinum toxin A injections according to the 3 domains of the International Classification of Functioning Disability and Health of the World Health Organisation
Read the detailed description
INTRODUCTION
Stroke is the third cause of death and the leading cause of handicap among industrialized countries. Spasticity and co-contraction of the rectus femoris muscle following stroke is responsible for a lack of knee flexion in the swing phase of gait named stiff knee gait.
The rectus femoris spasticity is usually treated by oral medications, physical therapy and botulinum toxin A injections (1,2). As botulinum toxin A has a transient effect, injections must be repeated supporting to promote a permanent surgical treatment such as the rectus femoris tenotomy (3). However, no study has evaluate neither compare the effect of the rectus femoris tenotomy on gait and on the 3 domains of the International Classification of Functioning Disability and Health .
OBJECTIVE
To compare the effect of the rectus femoris tenotomy and of the botulinum toxin A injections for stiff knee gait after stroke according to the 3 domains of the International Classification of Functioning Disability and Health
METHODS
The investigators will recruited 20 chronic stroke patients presenting with stiff knee gait. The patients will be randomly assigned to a surgical group treated by rectus femoris tenotomy (10 patients) and to a medical group treated by rectus femoris botulinum toxin A injections.
Patients will be assessed before treatment, 2 months and 6 months after treatment by an assessor blinded therapist among the 3 domains of the International Classification of Functioning Disability and Health
PERSPECTIVE
The investigator hope to demonstrate the effectiveness of the rectus femoris tenotomy as a treatment of stiff knee gait after stroke
- Conditions
- Stroke, Spasticity
- Being tested
- Tenotomy of the proximal rectus femoris tendon, Botulinum Toxin injection in the rectus femoris muscle
- Keywords
- Stroke, Muscle spasticity, Stiff knee gait, Botulinum toxin, Tenotomy
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenotomy of the proximal rectus femoris tendonProcedure or surgery
Also called Rectus femoris tenotomy
Surgical release of the proximal tendon of the rectus femoris
Botulinum Toxin injection in the rectus femoris muscleDrug
Also called Rectus femoris botulinum toxin A injections
Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution
| Study group | Role | What they receive |
|---|---|---|
| Rectus femoris tenotomy | Experimental | Surgical release of the proximal tendon of the rectus femoris Receives: Procedure: Tenotomy of the proximal rectus femoris tendon |
| Botulinum toxin in the rectus femoris muscle | Active comparator | Botulinum toxin (200U Botox) injection in the rectus femoris muscle Receives: Drug: Botulinum Toxin injection in the rectus femoris muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ashworth scale at the rectus femoris
Spasticity assessment scale
Measured: 6 months
Secondary outcomes (8)
Stroke impairment assessment set (SIAS
Body function and structure scale for stroke patients
Measured: 6 months
Tardieu scale
Spasiticty assessment scale
Measured: 6 months
MRC (Medical research Council) scale
Muscle strength scale
Measured: 6 months
Isometric muscle strenght assessment
Objective muscle strenght with isometric dynamometer
Measured: 6 months
10 meter walking test
Gait speed assessment scale
Measured: 6 months
Instrumented gait analysis
Kinetic and kinematic gait assessment in gait laboratory
Measured: 6 months
ABILOCO scale
Activity level scale for gait validated according to Rasch model
Measured: 6 months
EQ-5D-5L scale
Health quality of life scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deltombe Thierry, University Hospital of Mont-Godinne
- Investigators
- Thierry Deltombe, M.D., Principal investigator, University Hospital of Mont-Godinne, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114736
- Sponsor's protocol ID
- MG-SKG-57/2013
- Status last verified
- Apr 2014
- First submitted
- 19 Mar 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
PubMed 18164331Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
PubMed 18635841Namdari S, Pill SG, Makani A, Keenan MA. Rectus femoris to gracilis muscle transfer with fractional lengthening of the vastus muscles: a treatment for adults with stiff knee gait. Phys Ther. 2010 Feb;90(2):261-8. doi: 10.2522/ptj.20090151. Epub 2009 Dec 18.
PubMed 20023004
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Rectus Femoris Tenotomy Versus Botulinum Toxin A for Stiff Knee Gait After Stroke
- ClinicalTrials.gov ID
- NCT02114736
- Acronym / sponsor ID
- MG-SKG-57/2013
- Conditions
- Stroke, Spasticity
- Keywords
- Stroke, Muscle spasticity, Stiff knee gait, Botulinum toxin, Tenotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Apr 2014 (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.
Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee gait is a frequent condition among stroke patients leading to reduce gait speed and increase energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the rectus femoris is recommended. However, the botulinum toxin A effect is transient necessitating repeated injections.
The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison with botulinum toxin A injections according to the 3 domains of the International Classification of Functioning Disability and Health of the World Health Organisation
Detailed description
INTRODUCTION
Stroke is the third cause of death and the leading cause of handicap among industrialized countries. Spasticity and co-contraction of the rectus femoris muscle following stroke is responsible for a lack of knee flexion in the swing phase of gait named stiff knee gait.
The rectus femoris spasticity is usually treated by oral medications, physical therapy and botulinum toxin A injections (1,2). As botulinum toxin A has a transient effect, injections must be repeated supporting to promote a permanent surgical treatment such as the rectus femoris tenotomy (3). However, no study has evaluate neither compare the effect of the rectus femoris tenotomy on gait and on the 3 domains of the International Classification of Functioning Disability and Health .
OBJECTIVE
To compare the effect of the rectus femoris tenotomy and of the botulinum toxin A injections for stiff knee gait after stroke according to the 3 domains of the International Classification of Functioning Disability and Health
METHODS
The investigators will recruited 20 chronic stroke patients presenting with stiff knee gait. The patients will be randomly assigned to a surgical group treated by rectus femoris tenotomy (10 patients) and to a medical group treated by rectus femoris botulinum toxin A injections.
Patients will be assessed before treatment, 2 months and 6 months after treatment by an assessor blinded therapist among the 3 domains of the International Classification of Functioning Disability and Health
PERSPECTIVE
The investigator hope to demonstrate the effectiveness of the rectus femoris tenotomy as a treatment of stiff knee gait after stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus femoris tenotomy | Experimental | Procedure: Tenotomy of the proximal rectus femoris tendonSurgical release of the proximal tendon of the rectus femoris |
| Botulinum toxin in the rectus femoris muscle | Active comparator | Drug: Botulinum Toxin injection in the rectus femoris muscleBotulinum toxin (200U Botox) injection in the rectus femoris muscle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- stroke lasting for more than 6 months
- stiff knee gait
- rectus femoris spasticity (> Ashworth 2)
- transient improvement with previous botulinum toxine A injection in the rectus femoris
- stiff knee gait improved after rectus femoris diagnostic motor nere block
Key exclusion criteria (3 listed)
- pregnant women
- botulinum toxin A injections in the rectus femoris < 6 months
- previous surgery for stiff knee gait
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 |
|---|---|---|
| Tenotomy of the proximal rectus femoris tendonAlso: Rectus femoris tenotomySurgical release of the proximal tendon of the rectus femoris | Procedure or surgery | Rectus femoris tenotomy |
| Botulinum Toxin injection in the rectus femoris muscleAlso: Rectus femoris botulinum toxin A injectionsInjections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution | Drug | Botulinum toxin in the rectus femoris muscle |
Primary outcome
Ashworth scale at the rectus femoris
Time frame: 6 months
Spasticity assessment scale
8 secondary outcomes
Stroke impairment assessment set (SIAS
Time frame: 6 months
Tardieu scale
Time frame: 6 months
MRC (Medical research Council) scale
Time frame: 6 months
Isometric muscle strenght assessment
Time frame: 6 months
10 meter walking test
Time frame: 6 months
Instrumented gait analysis
Time frame: 6 months
ABILOCO scale
Time frame: 6 months
EQ-5D-5L scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Background: PubMed 18164331Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131.
- Background: PubMed 18635841Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of simultaneous botulinum toxin injections into several muscles on impairment, activity, participation, and quality of life among stroke patients presenting with a stiff knee gait. Stroke. 2008 Oct;39(10):2803-8. doi: 10.1161/STROKEAHA.108.516153. Epub 2008 Jul 17.
- Background: PubMed 20023004Namdari S, Pill SG, Makani A, Keenan MA. Rectus femoris to gracilis muscle transfer with fractional lengthening of the vastus muscles: a treatment for adults with stiff knee gait. Phys Ther. 2010 Feb;90(2):261-8. doi: 10.2522/ptj.20090151. Epub 2009 Dec 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.
Thierry Deltombe, M.D. principal investigator
University Hospital of Mont-Godinne, Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenotomy of the proximal rectus femoris tendon and Botulinum Toxin injection in the rectus femoris muscle in people with Stroke and Spasticity, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ashworth scale at the rectus femoris (time frame: 6 months). 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 NCT02114736, which also lists 3 linked publications.
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 15 Apr 2014.