StrokeLokomatNCT03659266
Effects of Combined Treatment by Botulinum Toxin and Lokomat® on Walking Ability in Chronic Stroke
A study testing Robotic walking rehabilitation by Lokomat® and Conventional walking rehabilitation in people with Stroke, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic walking rehabilitation by Lokomat® and Conventional walking rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2019to 2 Jul 2021
- 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
- Age between 18 and 80 years
- Left or right spastic hemiparesia after a single unilateral hemorrhagic or ischemic stroke, in chronic phase (at least 6 months after stroke)
- Functional hindrance in walking
- Spasticity of paretic triceps surae allowing for focal treatment by Botulinum toxin injection
Who cannot join
- Inability to walk with or without technical aids >5min
- Cognitive disorders disallowing informed consent
- Spasticity equal or superior to 4 on the triceps surae (On the Modified Ashworth Scale)
- Physical exercise not allowed: non stable cardiovascular or pulmonary disease in particular
- Lokomat® use not allowed: cutaneous lesions that could come in contact with the straps, non consolidated recent fracture (<3months), severe disability in controlling trunk balance disallowing correct posture in Lokomat®, intra-abdominal cranial flap, weight>135kg
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
About this study
Official title: Effects of Combined Treatment by Botulinum Toxin A and Robot-Assisted Gait Training (Lokomat®) on Walking Ability in Patients With Chronic Stroke: a Prospective, Controlled, Randomized Study
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.
To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature.
Read more
In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated.
Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy.
The aim of this study was to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase.
Outcome:
-Primary: distance walked (meters) in the six-minute walk test (SMWT)
Prospective, randomized, controlled, opened, monocentric study with a crossover design.
Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.
Assessment at Day one (D0), Week four (W4) and Week eight (W8).
Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy.
The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.
Read the detailed description
Introduction :
75% patients in the chronic phase of a stroke (>6 months) keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.
To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature.
In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated.
Materials and Methods:
Tested hypothesis:
Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy.
Aims:
- Primary: to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase.
- Secondary: to determine the optimal time between the toxin injection and the start of robotic rehabilitation; to evaluate the effects of the combined treatment on the balance and spasticity.
Outcome:
- Primary: distance walked (meters) in the six-minute walk test (SMWT)
- Secondary: walking speed (meters/seconds), balance (Timed Up and Go Test, Berg Balance Scale), spasticity (score on the Modified Ashworth Scale and joint range of motion)
Study Design:
Prospective, randomized, controlled, opened, monocentric study with a crossover design.
Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.
Assessment at Day one (D0), Week four (W4) and Week eight (W8).
- st Group D0: Injection of Botulinum toxin A in triceps surae, according to pre-established modalities (no influence of the experimental protocol on this stage) W2-W4: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization)
- nd Group: D0: Injection of Botulinum toxin A in triceps surae W2-W4: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization)
Expected results:
Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy.
The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.
- Conditions
- Stroke
- Being tested
- Robotic walking rehabilitation by Lokomat®, Conventional walking rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic walking rehabilitation by Lokomat®Other
Lokomat sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of effective work of the march and 15 minutes of setting up.
Conventional walking rehabilitationOther
5 physiotherapy sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of walking and 15 minutes of stretching
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | D0: Injection of Botulinum toxin A in triceps surae, according to pre-established modalities (no influence of the experimental protocol on this stage) W2-W4: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) Receives: Other: Robotic walking rehabilitation by Lokomat®; Other: Conventional walking rehabilitation |
| group 2 | Active comparator | D0: Injection of Botulinum toxin A in triceps surae W2-W4: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) Receives: Other: Robotic walking rehabilitation by Lokomat®; Other: Conventional walking rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Ten-meter walk test
Time is measure while the individual walks the set distance (10 meters). the distance covered is divided by the time it took the individual to walk that distance
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start7 Mar 2019
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659266
- Sponsor's protocol ID
- 2017-69
- Acronym
- Lokomat
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2018
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Treatment by Botulinum Toxin A and Robot-Assisted Gait Training (Lokomat®) on Walking Ability in Patients With Chronic Stroke: a Prospective, Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT03659266
- Acronym / sponsor ID
- Lokomat / 2017-69
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 6 Sep 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.
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.
To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature.
In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated.
Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy.
The aim of this study was to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase.
Outcome:
-Primary: distance walked (meters) in the six-minute walk test (SMWT)
Prospective, randomized, controlled, opened, monocentric study with a crossover design.
Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.
Assessment at Day one (D0), Week four (W4) and Week eight (W8).
Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy.
The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.
Detailed description
Introduction :
75% patients in the chronic phase of a stroke (>6 months) keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.
To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature.
In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated.
Materials and Methods:
Tested hypothesis:
Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy.
Aims:
- Primary: to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase.
- Secondary: to determine the optimal time between the toxin injection and the start of robotic rehabilitation; to evaluate the effects of the combined treatment on the balance and spasticity.
Outcome:
- Primary: distance walked (meters) in the six-minute walk test (SMWT)
- Secondary: walking speed (meters/seconds), balance (Timed Up and Go Test, Berg Balance Scale), spasticity (score on the Modified Ashworth Scale and joint range of motion)
Study Design:
Prospective, randomized, controlled, opened, monocentric study with a crossover design.
Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.
Assessment at Day one (D0), Week four (W4) and Week eight (W8).
- st Group D0: Injection of Botulinum toxin A in triceps surae, according to pre-established modalities (no influence of the experimental protocol on this stage) W2-W4: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization)
- nd Group: D0: Injection of Botulinum toxin A in triceps surae W2-W4: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization)
Expected results:
Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy.
The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Robotic walking rehabilitation by Lokomat®, Other: Conventional walking rehabilitationD0: Injection of Botulinum toxin A in triceps surae, according to pre-established modalities (no influence of the experimental protocol on this stage) W2-W4: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) |
| group 2 | Active comparator | Other: Robotic walking rehabilitation by Lokomat®, Other: Conventional walking rehabilitationD0: Injection of Botulinum toxin A in triceps surae W2-W4: Conventional walking rehabilitation in the functional rehabilitation department (conventional hospitalization) W4-W6: Return to home, "wash-out"period W6-W8: Robotic walking rehabilitation by Lokomat® in the functional rehabilitation department (conventional hospitalization) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- Left or right spastic hemiparesia after a single unilateral hemorrhagic or ischemic stroke, in chronic phase (at least 6 months after stroke)
- Functional hindrance in walking
- Spasticity of paretic triceps surae allowing for focal treatment by Botulinum toxin injection
Key exclusion criteria (5 listed)
- Inability to walk with or without technical aids >5min
- Cognitive disorders disallowing informed consent
- Spasticity equal or superior to 4 on the triceps surae (On the Modified Ashworth Scale)
- Physical exercise not allowed: non stable cardiovascular or pulmonary disease in particular
- Lokomat® use not allowed: cutaneous lesions that could come in contact with the straps, non consolidated recent fracture (<3months), severe disability in controlling trunk balance disallowing correct posture in Lokomat®, intra-abdominal cranial flap, weight>135kg
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 |
|---|---|---|
| Robotic walking rehabilitation by Lokomat®Lokomat sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of effective work of the march and 15 minutes of setting up. | Other | Group 1, group 2 |
| Conventional walking rehabilitation5 physiotherapy sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of walking and 15 minutes of stretching | Other | Group 1, group 2 |
Primary outcome
Time of Ten-meter walk test
Time frame: 20 minutes
Time is measure while the individual walks the set distance (10 meters). the distance covered is divided by the time it took the individual to walk that distance
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 14 Jun 2024.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic walking rehabilitation by Lokomat® and Conventional walking rehabilitation in people with Stroke, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 5 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 14 Jun 2024. 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?
Time of Ten-meter walk test (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.