Self Rehabilitation Combined With BTI on Upper LimbArmautotoxNCT02699762
Upper Limb Botulinum Toxin Injection Combined With Self Rehabilitation
A study testing self rehabilitation of upper limb in experimental group in people with Self Rehabilitation Combined With BTI on Upper Limb, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
To show that the addition of a self-rehabilitation program to standard treatment, involving repeated BTI and usual physiotherapy, improves impairment and activity limitation of the paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a randomised controlled study of patients with spastic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Rehabilitation Combined With BTI on Upper Limb
- What is being tested?
- self rehabilitation of upper limb in experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Mar 2018
- 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
- Males and females aged from 18 to 75 years inclusive.
- Women at least 24 months post menopause, or having undergone surgical sterilisation or using an effective method of contraception (oral or injected contraception or patches or a double-barrier intrauterine device).
- Signing of the informed consent form indicating that the subject has understood the aim of the study as well as the procedures involved and that he/she accepts to participate and to comply with the demands and restrictions inherent to the study
- Affiliation to the French social security regime or a similar regime.
- Single stroke more than 6 months previously
- Capable of understanding instructions and to participate in the definition of a therapeutic goal
Show all 9Show fewer
- Voluntary movement of the shoulder and elbow
- Able to participate in a self-rehabilitation program
- Having previously undergone BTI. The last injection must be at least 4 months prior to inclusion.
Who cannot join
- Subjects who are unlikely to adhere to the study and/or poor adherence anticipated by the investigator
- Patient with no medical insurance
- Pregnant woman
- Uncontrolled progressive pathology
- Comprehension deficit (Boston Diagnostic Aphasia Examination(BDAE) <3)
- Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study
Show all 9Show fewer
- Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.)
- Surgery to the paretic limb treated in the study less than 6 months previously
- Contra-indications to botulinum toxin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Upper Limb Function in Stroke
To show that the addition of a self-rehabilitation program to standard treatment, involving repeated BTI and usual physiotherapy, improves impairment and activity limitation of the paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a randomised controlled study of patients with spastic hemiparesis following stroke.
Read the detailed description
Following stroke, 30% of patients are left with a "hemiplegic" upper limb meaning that they are unable to carry out any movements with the limb and are thus partially or totally dependent for all activities of daily living (dressing, washing, feeding etc). Another 40% have some proximal recovery. These patients are able to carry out some movement of the shoulder and sometimes the elbow. They can use the limb for some activities of daily living such as carrying a bag or stabilising paper while writing. The last 30% recover a certain degree of prehension, however their motor control is altered and they have impairments of both the reaching and grasping phases.
Treatment for chronic stroke symptoms (more than 6 months post-onset) including impairments and activity limitations is mostly based on physiotherapy and botulinum toxin injections (BTI).
Physiotherapy : This treatment has been shown to be effective, and is essential to reduce impairments and improve function in patients with hemiparesis following stroke (Robertson et al, 2008 ; Bourgeais et al, 2010). Different methods exist, and comparative studies of the most common ones have shown a similar effectiveness (Adal et al, 2006 ; Flansbjer et al, 2008 ; Brazzelli et al, 2011, Durstine et al 2009). No conventional treatment has been shown to be more effective than another. However, it has been demonstrated that the intensity and specificity of rehabilitation techniques are positively correlated with motor recovery (Gordon et al, 2004).
Intensity of rehabilitation: In 2006, a meta-analysis of 21 studies on the effect of muscle strengthening post stroke showed that it improved active function and activities of daily living (measured on different scales) following acute and chronic stroke (Ada et al, 2006). Currently, a meta-analysis by Brazzelli et al. (2011) contains the largest collection of data, with 32 studies and a total of 1414 participants. The studies included were on the subject of cardiovascular training, muscle strengthening and mixed training (cardiovascular+strength). The main outcome measures were the incidence of mortality and the degree of dependence and disability. The results showed improvements following cardiovascular training and mixed training. Strength training alone did not significantly improve mobility. These results lead the American College of Sport and Medicine to recommend endurance and strength training coupled with stretching for stroke patients.
Task-oriented training : Carr et Shepherd (1998) were the first to promote task oriented training. More recently, Van de port et al, (2009-2012) evaluated 250 patients following 12 weeks of task-oriented circuit training (126 patients) or conventional physiotherapy (124 patients). All the patients were at least 6 months post stroke. The training consisted of 6-minute work stations with 8 different exercises, such as rising from a chair to reach different targets, picking up objects from the floor while walking, kicking a ball, crossing obstacles, ascending and descending stairs etc. Greater improvements occurred in the task-oriented group for the six-minute walk test and the Stair test (time to ascend and descend a flight of 10 stairs. Another meta-analysis (including 307 participants) demonstrated that task-oriented training improves distance walked, gait speed and the Timed Up and Go test (rising from a chair, walking 3 metres, turning and returning to sit) (Wevers et al, 2009). These results show that training should involve practice of the specific function to be improved.
Botulinum toxin injections : Botulinum toxin is a neurotoxin produced by the clostridium botulinum bacteria. Seven different serotypes exist but only the A and B serotypes are used in clinical practice. Botulinum toxin blocks the presynaptic release of neurotransmitter at the neuromuscular junction. Focal transitory paralysis thus occurs in the injected muscle. Its action lasts on average 3 months in striated skeletal muscle. The effect of BTI in the upper limb depends on the parameters studied. A meta-analysis carried out by Foley et al, 2013 showed a relatively large effect size for the reduction of impairment and the improvement of passive function. However, there was only a small effect size for the improvement of functions such as prehension. This confirms the results of a previous study (Sheean et al, 2010) which showed that the effect of BTI in the upper limb was only significant for the reduction of impairment or the improvement of passive function, but not active function.
These results were further confirmed in a study which used goal attainment scaling as an outcome measure (Turner Stokes et al, 2010). Following BTI in the upper limb of hemiparetic patients, there was a significant improvement in the goal attainment scaling score which was, moreover, strongly correlated with the reduction in spasticity evaluated with the Ashworth scale (most widely used scale for the evaluation of spasticity). The results also showed that the goal was more often attained when it involved the improvement of a passive function than an active function. The only study to have shown an improvement in prehension following BTI involved combined treatment with constraint induced therapy (Sun et al, 2010).
Self-rehabilitation Two recent studies have shown that rehabilitation coupled with BTI could have a significant effect on activity limitation: A pilot randomised controlled trial of 35 patients with spastic hemiparesis by Roche et al (2014) showed that a 30-minute, daily self-rehabilitation program coupled with a single session of BTI in the lower limb significantly improved several gait-related activities. The self-rehabilitation program was developed to combine different types of exercises including: i) strengthening of the hip flexors and extensors and the triceps sural; ii) stretching of the rectus femoris, hamstrings and triceps sural and iii) task-oriented gait-related exercises including obstacle crossing and slaloming. They showed significantly greater improvements in the experimental group than the control group for maximal gait speed in the 10-metre walk test, distance walked in the 6-minute walk test and the time to ascend and descend a flight of stairs. Sun et al (2010) carried out a randomised controlled trial which included 32 patients with stroke. They showed that constraint-induced therapy in the paretic upper limb coupled with BTI significantly improved prehension and reduced spasticity in the finger and wrist flexors more than BTI coupled with standard therapy.
In summary Together, these results indicate that the addition of a self-rehabilitation program to botulinum toxin injections is the most pertinent method to optimise the effects of BTI and usual therapy. However, no study has yet evaluated the effects of the addition of a self-rehabilitation program to treatment by BTI and usual therapy.
Moreover, this corresponds to a public health issue which is to provide a greater intensity of rehabilitation within the constraints of the health system, including lack of funding and lack of physiotherapists trained in this type of specialised rehabilitation.
- Being tested
- self rehabilitation of upper limb in experimental group
- Keywords
- self rehabilitation, stroke, botulinum toxin injection, arm functions
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self rehabilitation of upper limb in experimental groupOther
The patients in the self-rehabilitation group will be taught the self-rehabilitation program by a physiotherapist who is not involved in the patient follow-up. They will receive a log book which will be used to evaluate compliance and tolerance to the program. They will be instructed to carry out the exercises 7 days per week for the whole duration of the study and to record which exercises they carried out and for how long, after each exercise session.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | self rehabilitation of upper limb in experimental group + BTI + usual physiotherapy Receives: Other: self rehabilitation of upper limb in experimental group |
| control group | No intervention | BTI + usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
wolf-motor functional test (WMFT)
functional hemiplegic's arm evaluation
Measured: 1h
Secondary outcomes (1)
modified Ashworth scale
spasticity evaluation
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionMar 2018
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 Self Rehabilitation Combined With BTI on Upper LimbStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD PhD, Principal investigator, Raymond Poincare HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699762
- Sponsor's protocol ID
- 2015-A01677-42
- Acronym
- Armautotox
- Status last verified
- Jan 2018
- First submitted
- 1 Mar 2016
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maulet T, Pouplin S, Bensmail D, Zory R, Roche N, Bonnyaud C. Self-rehabilitation combined with botulinum toxin to improve arm function in people with chronic stroke. A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101450. doi: 10.1016/j.rehab.2020.10.004. Epub 2020 Dec 17.
PubMed 33152520
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Upper Limb Function in Stroke
- ClinicalTrials.gov ID
- NCT02699762
- Acronym / sponsor ID
- Armautotox / 2015-A01677-42
- Keywords
- self rehabilitation, stroke, botulinum toxin injection, arm functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Mar 2016 (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.
To show that the addition of a self-rehabilitation program to standard treatment, involving repeated BTI and usual physiotherapy, improves impairment and activity limitation of the paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a randomised controlled study of patients with spastic hemiparesis following stroke.
Detailed description
Following stroke, 30% of patients are left with a "hemiplegic" upper limb meaning that they are unable to carry out any movements with the limb and are thus partially or totally dependent for all activities of daily living (dressing, washing, feeding etc). Another 40% have some proximal recovery. These patients are able to carry out some movement of the shoulder and sometimes the elbow. They can use the limb for some activities of daily living such as carrying a bag or stabilising paper while writing. The last 30% recover a certain degree of prehension, however their motor control is altered and they have impairments of both the reaching and grasping phases.
Treatment for chronic stroke symptoms (more than 6 months post-onset) including impairments and activity limitations is mostly based on physiotherapy and botulinum toxin injections (BTI).
Physiotherapy : This treatment has been shown to be effective, and is essential to reduce impairments and improve function in patients with hemiparesis following stroke (Robertson et al, 2008 ; Bourgeais et al, 2010). Different methods exist, and comparative studies of the most common ones have shown a similar effectiveness (Adal et al, 2006 ; Flansbjer et al, 2008 ; Brazzelli et al, 2011, Durstine et al 2009). No conventional treatment has been shown to be more effective than another. However, it has been demonstrated that the intensity and specificity of rehabilitation techniques are positively correlated with motor recovery (Gordon et al, 2004).
Intensity of rehabilitation: In 2006, a meta-analysis of 21 studies on the effect of muscle strengthening post stroke showed that it improved active function and activities of daily living (measured on different scales) following acute and chronic stroke (Ada et al, 2006). Currently, a meta-analysis by Brazzelli et al. (2011) contains the largest collection of data, with 32 studies and a total of 1414 participants. The studies included were on the subject of cardiovascular training, muscle strengthening and mixed training (cardiovascular+strength). The main outcome measures were the incidence of mortality and the degree of dependence and disability. The results showed improvements following cardiovascular training and mixed training. Strength training alone did not significantly improve mobility. These results lead the American College of Sport and Medicine to recommend endurance and strength training coupled with stretching for stroke patients.
Task-oriented training : Carr et Shepherd (1998) were the first to promote task oriented training. More recently, Van de port et al, (2009-2012) evaluated 250 patients following 12 weeks of task-oriented circuit training (126 patients) or conventional physiotherapy (124 patients). All the patients were at least 6 months post stroke. The training consisted of 6-minute work stations with 8 different exercises, such as rising from a chair to reach different targets, picking up objects from the floor while walking, kicking a ball, crossing obstacles, ascending and descending stairs etc. Greater improvements occurred in the task-oriented group for the six-minute walk test and the Stair test (time to ascend and descend a flight of 10 stairs. Another meta-analysis (including 307 participants) demonstrated that task-oriented training improves distance walked, gait speed and the Timed Up and Go test (rising from a chair, walking 3 metres, turning and returning to sit) (Wevers et al, 2009). These results show that training should involve practice of the specific function to be improved.
Botulinum toxin injections : Botulinum toxin is a neurotoxin produced by the clostridium botulinum bacteria. Seven different serotypes exist but only the A and B serotypes are used in clinical practice. Botulinum toxin blocks the presynaptic release of neurotransmitter at the neuromuscular junction. Focal transitory paralysis thus occurs in the injected muscle. Its action lasts on average 3 months in striated skeletal muscle. The effect of BTI in the upper limb depends on the parameters studied. A meta-analysis carried out by Foley et al, 2013 showed a relatively large effect size for the reduction of impairment and the improvement of passive function. However, there was only a small effect size for the improvement of functions such as prehension. This confirms the results of a previous study (Sheean et al, 2010) which showed that the effect of BTI in the upper limb was only significant for the reduction of impairment or the improvement of passive function, but not active function.
These results were further confirmed in a study which used goal attainment scaling as an outcome measure (Turner Stokes et al, 2010). Following BTI in the upper limb of hemiparetic patients, there was a significant improvement in the goal attainment scaling score which was, moreover, strongly correlated with the reduction in spasticity evaluated with the Ashworth scale (most widely used scale for the evaluation of spasticity). The results also showed that the goal was more often attained when it involved the improvement of a passive function than an active function. The only study to have shown an improvement in prehension following BTI involved combined treatment with constraint induced therapy (Sun et al, 2010).
Self-rehabilitation Two recent studies have shown that rehabilitation coupled with BTI could have a significant effect on activity limitation: A pilot randomised controlled trial of 35 patients with spastic hemiparesis by Roche et al (2014) showed that a 30-minute, daily self-rehabilitation program coupled with a single session of BTI in the lower limb significantly improved several gait-related activities. The self-rehabilitation program was developed to combine different types of exercises including: i) strengthening of the hip flexors and extensors and the triceps sural; ii) stretching of the rectus femoris, hamstrings and triceps sural and iii) task-oriented gait-related exercises including obstacle crossing and slaloming. They showed significantly greater improvements in the experimental group than the control group for maximal gait speed in the 10-metre walk test, distance walked in the 6-minute walk test and the time to ascend and descend a flight of stairs. Sun et al (2010) carried out a randomised controlled trial which included 32 patients with stroke. They showed that constraint-induced therapy in the paretic upper limb coupled with BTI significantly improved prehension and reduced spasticity in the finger and wrist flexors more than BTI coupled with standard therapy.
In summary Together, these results indicate that the addition of a self-rehabilitation program to botulinum toxin injections is the most pertinent method to optimise the effects of BTI and usual therapy. However, no study has yet evaluated the effects of the addition of a self-rehabilitation program to treatment by BTI and usual therapy.
Moreover, this corresponds to a public health issue which is to provide a greater intensity of rehabilitation within the constraints of the health system, including lack of funding and lack of physiotherapists trained in this type of specialised rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: self rehabilitation of upper limb in experimental groupself rehabilitation of upper limb in experimental group + BTI + usual physiotherapy |
| control group | No intervention | –BTI + usual physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females aged from 18 to 75 years inclusive.
- Women at least 24 months post menopause, or having undergone surgical sterilisation or using an effective method of contraception (oral or injected contraception or patches or a double-barrier intrauterine device).
- Signing of the informed consent form indicating that the subject has understood the aim of the study as well as the procedures involved and that he/she accepts to participate and to comply with the demands and restrictions inherent to the study
- Affiliation to the French social security regime or a similar regime.
- Single stroke more than 6 months previously
Key exclusion criteria (9 listed)
- Subjects who are unlikely to adhere to the study and/or poor adherence anticipated by the investigator
- Patient with no medical insurance
- Pregnant woman
- Uncontrolled progressive pathology
- Comprehension deficit (Boston Diagnostic Aphasia Examination(BDAE) <3)
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 |
|---|---|---|
| self rehabilitation of upper limb in experimental groupThe patients in the self-rehabilitation group will be taught the self-rehabilitation program by a physiotherapist who is not involved in the patient follow-up. They will receive a log book which will be used to evaluate compliance and tolerance to the program. They will be instructed to carry out the exercises 7 days per week for the whole duration of the study and to record which exercises they carried out and for how long, after each exercise session. | Other | experimental group |
Primary outcome
wolf-motor functional test (WMFT)
Time frame: 1h
functional hemiplegic's arm evaluation
1 secondary outcome
modified Ashworth scale
Time frame: 15 minutes
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 13 Apr 2018.
- Derived from this study: PubMed 33152520Maulet T, Pouplin S, Bensmail D, Zory R, Roche N, Bonnyaud C. Self-rehabilitation combined with botulinum toxin to improve arm function in people with chronic stroke. A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jul;64(4):101450. doi: 10.1016/j.rehab.2020.10.004. Epub 2020 Dec 17.
- Individual participant dataSharing planned: No
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.
Nicolas ROCHE, MD PhD principal investigator
Raymond Poincare HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self rehabilitation of upper limb in experimental group in people with Self Rehabilitation Combined With BTI on Upper Limb, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 9 inclusion and 9 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 13 Apr 2018. 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 France. 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 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?
wolf-motor functional test (WMFT) (time frame: 1h). 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 NCT02699762, 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 13 Apr 2018.