Spastic HemiparesisPhase 3ADJU-TOXNCT02944929
The Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke
A Phase 3 study testing Self-rehabilitation program in people with Spastic Hemiparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spastic Hemiparesis
- What is being tested?
- Self-rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 3 Jan 2021
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged between 18 to 75 years.
- Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
- Single stroke having occurred more than 6 months before (previous TIA is accepted).
- Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) < 3).
- Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
- Affiliation to the French social security regime or a similar regime.
- Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form.
Who cannot join
- Patients who are unwilling to participate in the study. For the one under guardianship, the refusal of the patient will be the final decision even if the guardian is willing to participate.
- Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
- Un-controlled progressive pathology.
- Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
- Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
- Surgery to the treated limb less than 6 months previously.
- Pregnant woman.
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 (Repeated Botulinum Toxin Injections and Physiotherapy) on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke
The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.
Read the detailed description
Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced.
The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI).
BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy.
Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010).
The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke.
- Conditions
- Spastic Hemiparesis
- Being tested
- Self-rehabilitation program
- Keywords
- Spastic hemiparesis, Stroke, Self-rehabilitation, Botulinum Toxin Injections
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-rehabilitation programOther
The self-rehabilitation program will be based on muscle stretching, strengthening and task oriented exercises. For each patient, two exercises will be selected by the therapist for each of these 3 domains (total of 6 exercises) from a list of 50 exercises.
| Study group | Role | What they receive |
|---|---|---|
| Self-rehabilitation program | Experimental | Self-rehabilitation program + standard medical care (BTI + conventional physiotherapy) Receives: Other: Self-rehabilitation program |
| Control arm | No intervention | Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Goal Attainment Scaling (GAS).
The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups.
Measured: 6 months
Secondary outcomes (4)
Assessment of the Functional Independence Measure (FIM)
Measured: 6 months
Assessment of Hemispatial neglect
Measured: 6 months
Quality of life questionnaire
Measured: 6 months
Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment)
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 posted26 Oct 2016 (estimated)
- Study start1 Jan 2018
- Primary completionDec 2020 (estimated)
- Study completion3 Jan 2021 (estimated)
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 Spastic HemiparesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Roche, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944929
- Sponsor's protocol ID
- P150907
- Acronym
- ADJU-TOX
- Status last verified
- Mar 2020
- First submitted
- 14 Sep 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonnyaud C, Gallien P, Decavel P, Marque P, Aymard C, Pellas F, Isner ME, Boyer FC, Muller F, Daviet JC, Dehail P, Perrouin-Verbe B, Bayle N, Coudeyre E, Perennou D, Laffont I, Ropers J, Domingo-Saidji NY, Bensmail D, Roche N; ADJU-TOX Study Group. Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study. BMJ Open. 2018 Aug 30;8(8):e020915. doi: 10.1136/bmjopen-2017-020915.
PubMed 30166290
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. 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 (Repeated Botulinum Toxin Injections and Physiotherapy) on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke
- ClinicalTrials.gov ID
- NCT02944929
- Acronym / sponsor ID
- ADJU-TOX / P150907
- Conditions
- Spastic Hemiparesis
- Keywords
- Spastic hemiparesis, Stroke, Self-rehabilitation, Botulinum Toxin Injections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 3 Jan 2021 (estimated)
- First posted
- 26 Oct 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.
The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.
Detailed description
Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced.
The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI).
BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy.
Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010).
The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-rehabilitation program | Experimental | Other: Self-rehabilitation programSelf-rehabilitation program + standard medical care (BTI + conventional physiotherapy) |
| Control arm | No intervention | –Arm with standard medical care ( BTI + conventional physiotherapy) without self-rehabilitation program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged between 18 to 75 years.
- Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
- Single stroke having occurred more than 6 months before (previous TIA is accepted).
- Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) < 3).
- Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
Key exclusion criteria (7 listed)
- Patients who are unwilling to participate in the study. For the one under guardianship, the refusal of the patient will be the final decision even if the guardian is willing to participate.
- Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
- Un-controlled progressive pathology.
- Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
- Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
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 programThe self-rehabilitation program will be based on muscle stretching, strengthening and task oriented exercises. For each patient, two exercises will be selected by the therapist for each of these 3 domains (total of 6 exercises) from a list of 50 exercises. | Other | Self-rehabilitation program |
Primary outcome
Assessment of Goal Attainment Scaling (GAS).
Time frame: 6 months
The percentage of patients who attain their Primary Treatment Goal determined using Goal Attainment Scaling (GAS) at each visits and in both groups.
4 secondary outcomes
Assessment of the Functional Independence Measure (FIM)
Time frame: 6 months
Assessment of Hemispatial neglect
Time frame: 6 months
Quality of life questionnaire
Time frame: 6 months
Assessment of slight deficits according MOCA scale (Montréal Cognitive Assessment)
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 27 Mar 2020.
- Derived from this study: PubMed 30166290Bonnyaud C, Gallien P, Decavel P, Marque P, Aymard C, Pellas F, Isner ME, Boyer FC, Muller F, Daviet JC, Dehail P, Perrouin-Verbe B, Bayle N, Coudeyre E, Perennou D, Laffont I, Ropers J, Domingo-Saidji NY, Bensmail D, Roche N; ADJU-TOX Study Group. Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study. BMJ Open. 2018 Aug 30;8(8):e020915. doi: 10.1136/bmjopen-2017-020915.
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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.
Nicolas Roche, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-rehabilitation program in people with Spastic Hemiparesis, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 7 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 27 Mar 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Nicolas Roche, MD (+ 33(1) 47 10 54 09, roche.nicolas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Goal Attainment Scaling (GAS). (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 NCT02944929, 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 27 Mar 2020.