StrokePhase 3BB200810NCT01187277
Robotic Versus Conventional Training on Hemiplegic Gait.
A Phase 3 study testing conventional therapy and conventional plus robotic gait assisted therapy in people with Stroke, run by Prasat Neurological Institute at 1 site in Thailand.
Trial summary
The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- conventional therapy and conventional plus robotic gait assisted therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2011to Jul 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacute first-time stroke patients(hemorrhage and ischemic)
- Age 18-80 years.
- Impaired Functional Ambulation Category at initial score 0-2
- Cardiovascular stable
- Given signed inform consent
Who cannot join
- Unstable general medical condition
- Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
- Any functional impairment prior to stroke
- Can not adequately cooperate in training
- Severe communication problems
- Severe cognitive - perceptual deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.
The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.
- Conditions
- Stroke
- Being tested
- conventional therapy, conventional plus robotic gait assisted therapy
- Keywords
- stroke, rehabilitation, gait training, robot-assisted therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyBehavioural
conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
conventional plus robotic gait assisted therapyDevice
Also called Gait trainer GT1
individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks Receives: Behavioral: conventional therapy |
| Group B | Active comparator | Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks Receives: Device: conventional plus robotic gait assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Categories (FAC, 0-5)
Description of ambulation level of the individual patient, whether and if, how much support is needed.
Measured: 4 weeks
Barthel index (BI, 0-100)
Assesses independence in activity of daily living
Measured: 4 weeks
Secondary outcomes (2)
Berg Balance Scale (BBS, 0-56
Assesses balance abilities.
Measured: 4 weeks
REPAS -Muscle tone (REPAS, 0-52)
Sum score to assess muscle tone for the major joints of the upper and lower extremities.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prasat Neurological Institute
- Sponsor type
- Other government
- Collaborators
- Mahidol University, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Ratanapat Chanubol, Prasat Neurological Institute
- Investigators
- Ratanapat Chanubol, M.D., Principal investigator, Rehabilitation department, Prasat Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187277
- Sponsor's protocol ID
- BB200810
- Acronym
- BB200810
- Status last verified
- Jul 2012
- First submitted
- 20 Aug 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwartz I, Sajin A, Fisher I, Neeb M, Shochina M, Katz-Leurer M, Meiner Z. The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. PM R. 2009 Jun;1(6):516-23. doi: 10.1016/j.pmrj.2009.03.009.
PubMed 19627940Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8.
PubMed 18467648Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632.
PubMed 19109447Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
PubMed 17213237
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.
- ClinicalTrials.gov ID
- NCT01187277
- Acronym / sponsor ID
- BB200810 / BB200810
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, gait training, robot-assisted therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prasat Neurological InstituteOther government
- Collaborators
- Mahidol University, Charite University, Berlin, Germany
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Aug 2010 (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 incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions 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 |
|---|---|---|
| Group A | Experimental | Behavioral: conventional therapyGroup A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks |
| Group B | Active comparator | Device: conventional plus robotic gait assisted therapyGroup B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subacute first-time stroke patients(hemorrhage and ischemic)
- Age 18-80 years.
- Impaired Functional Ambulation Category at initial score 0-2
- Cardiovascular stable
- Given signed inform consent
Key exclusion criteria (6 listed)
- Unstable general medical condition
- Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
- Any functional impairment prior to stroke
- Can not adequately cooperate in training
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 |
|---|---|---|
| conventional therapyconventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks | Behavioural | Group A |
| conventional plus robotic gait assisted therapyAlso: Gait trainer GT1individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy | Device | Group B |
Primary outcome
Functional Ambulation Categories (FAC, 0-5)
Time frame: 4 weeks
Description of ambulation level of the individual patient, whether and if, how much support is needed.
Barthel index (BI, 0-100)
Time frame: 4 weeks
Assesses independence in activity of daily living
2 secondary outcomes
Berg Balance Scale (BBS, 0-56
Time frame: 4 weeks
REPAS -Muscle tone (REPAS, 0-52)
Time frame: 4 weeks
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 17 Jul 2012.
- Results publication: PubMed 19627940Schwartz I, Sajin A, Fisher I, Neeb M, Shochina M, Katz-Leurer M, Meiner Z. The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. PM R. 2009 Jun;1(6):516-23. doi: 10.1016/j.pmrj.2009.03.009.
- Results publication: PubMed 18467648Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8.
- Results publication: PubMed 19109447Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632.
- Results publication: PubMed 17213237Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
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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.
Ratanapat Chanubol, M.D. principal investigator
Rehabilitation department, Prasat Neurological Institute
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 conventional therapy and conventional plus robotic gait assisted therapy in people with Stroke, run by Prasat Neurological Institute at 1 site in Thailand.
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 5 inclusion and 6 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 17 Jul 2012. 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 Thailand. 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?
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?
Functional Ambulation Categories (FAC, 0-5) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01187277, which also lists 4 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 17 Jul 2012.