StrokeEarly Phase 1GTSNCT00612300
Gait Training for Persons With Stroke
A Early Phase 1 study testing Lokomat - Physical therapy and Physical therapy - Lokomat in people with Stroke and Middle Cerebral Artery Infarction, run by University of Aarhus at 1 site in Denmark.
Trial summary
The objective of this study is to investigate the effects of an automatic gait trainer (Lokomat) handled by physical therapists compared with categorized gait training by physical therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are used to evaluate study effects. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Middle Cerebral Artery Infarction
- What is being tested?
- Lokomat - Physical therapy and Physical therapy - Lokomat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2007to Jun 2009
- Phase
- Early Phase 1
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time Stroke
- Middle cerebral artery infarction
- Less than three month from stroke onset
- Able to walk with or without a stick at gait speed less than 0.5 m/s
- Participants are able to cope with the Lokomat
Who cannot join
- Co-morbidity which impedes study participations
- Language deficits which makes it impossible to understand oral or written study instructions
- More than 190 cm tall and 135 kg in weight
- Pregnancy
- No gait function prior stroke
- Skin sore or eruption on lower extremity or trunk, differences in lower extremity length of more than 2 cm or contracture of lower extremity which impedes gait training in the Lokomat -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke
The objective of this study is to investigate the effects of an automatic gait trainer (Lokomat) handled by physical therapists compared with categorized gait training by physical therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are used to evaluate study effects.
Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more than categorized gait training.
- Conditions
- Stroke, Middle Cerebral Artery Infarction
- Being tested
- Lokomat - Physical therapy, Physical therapy - Lokomat
- Keywords
- Ambulatory stroke patients, Gait training, Lokomat, Physical therapy
- Medical subject headings
- Stroke, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat - Physical therapyBehavioural
A: Lokomat training, 30 minutes per day for 3 weeks, 5 days per week. B: Categorized gait training by physical therapist, 30 minutes per day for 3 weeks, 5 days per week
Physical therapy - LokomatBehavioural
B: Daily 30 minutes of gait training with a physical therapist, 5 days per week for 3 weeks.
A: Daily 30 minutes of Lokomat training, 5 days per week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A-B | Experimental | Gait training by an automatic gait trainer (Lokomat) for 3 weeks followed by 3 weeks of categorized gait training by a physical therapist Receives: Behavioral: Lokomat - Physical therapy |
| B-A | Experimental | Categorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training Receives: Behavioral: Physical therapy - Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters walking test (gait speed)
Measured: at inclusion, week 3 and week 6
Secondary outcomes (3)
Six minutes walking test
Measured: Inclusion, wek 3 and week 6
Gait symmetry index
Measured: Inclusion, week 3 and week 6
Timed Up And Go
Measured: Inclusion, Week 3 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 2009
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jørgen F Nielsen, Professor, Study chair, Hammel Neurorehabilitation and Research Center, DenmarkCarsten Kock-Jensen, MD, Study director, Hammel Neurorehabilitation and Research Center, DenmarkJohn Brincks, PhD student, Principal investigator, Hammel Neurorehabilitation and Reseach Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612300
- Sponsor's protocol ID
- 2
- Acronym
- GTS
- Status last verified
- Feb 2010
- First submitted
- 28 Jan 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke
- ClinicalTrials.gov ID
- NCT00612300
- Acronym / sponsor ID
- GTS / 2
- Conditions
- Stroke, Middle Cerebral Artery Infarction
- Keywords
- Ambulatory stroke patients, Gait training, Lokomat, Physical therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Feb 2008 (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 objective of this study is to investigate the effects of an automatic gait trainer (Lokomat) handled by physical therapists compared with categorized gait training by physical therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are used to evaluate study effects.
Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more than categorized gait training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-B | Experimental | Behavioral: Lokomat - Physical therapyGait training by an automatic gait trainer (Lokomat) for 3 weeks followed by 3 weeks of categorized gait training by a physical therapist |
| B-A | Experimental | Behavioral: Physical therapy - LokomatCategorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First time Stroke
- Middle cerebral artery infarction
- Less than three month from stroke onset
- Able to walk with or without a stick at gait speed less than 0.5 m/s
- Participants are able to cope with the Lokomat
Key exclusion criteria (6 listed)
- Co-morbidity which impedes study participations
- Language deficits which makes it impossible to understand oral or written study instructions
- More than 190 cm tall and 135 kg in weight
- Pregnancy
- No gait function prior stroke
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 |
|---|---|---|
| Lokomat - Physical therapyA: Lokomat training, 30 minutes per day for 3 weeks, 5 days per week. B: Categorized gait training by physical therapist, 30 minutes per day for 3 weeks, 5 days per week | Behavioural | A-B |
| Physical therapy - LokomatB: Daily 30 minutes of gait training with a physical therapist, 5 days per week for 3 weeks. A: Daily 30 minutes of Lokomat training, 5 days per week for 3 weeks. | Behavioural | B-A |
Primary outcome
10 meters walking test (gait speed)
Time frame: at inclusion, week 3 and week 6
3 secondary outcomes
Six minutes walking test
Time frame: Inclusion, wek 3 and week 6
Gait symmetry index
Time frame: Inclusion, week 3 and week 6
Timed Up And Go
Time frame: Inclusion, Week 3 and Week 6
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 Feb 2010.
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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.
Jørgen F Nielsen, Professor study chair
Hammel Neurorehabilitation and Research Center, Denmark
Carsten Kock-Jensen, MD study director
Hammel Neurorehabilitation and Research Center, Denmark
John Brincks, PhD student principal investigator
Hammel Neurorehabilitation and Reseach Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lokomat - Physical therapy and Physical therapy - Lokomat in people with Stroke and Middle Cerebral Artery Infarction, run by University of Aarhus at 1 site in Denmark.
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 Feb 2010. 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 Denmark. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
10 meters walking test (gait speed) (time frame: at inclusion, week 3 and week 6). 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 17 Feb 2010.