Post Stroke Gait TrainingLOKOMATNCT02189551
Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System
A study testing Gait training with Lokomat Pro and Gait training with Lokomat Pro FreeD in people with Post Stroke Gait Training, run by Cereneo AG at 1 site in Switzerland.
Trial summary
The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke Gait Training
- What is being tested?
- Gait training with Lokomat Pro and Gait training with Lokomat Pro FreeD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Feb 2015
- Phase
- Interventional
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
- Lower extremity weakness due to stroke
- minor functional impairment (MRC < 5)
- ability and willingness to participate
Who cannot join
- severe spasticity of the lower extremities
- severe dementia
- severe depression
- any other contraindications against Lokomat training
- body weight > 135 kg
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cereneo, Center For Rehabilitation and Neurology
Vitznau, Canton of Lucerne, 6354
About this study
The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective).
Primary study endpoints will be a significantly higher rated patient comfort and or patient satisfaction using the new versions, compared with the established Lokomat. Furthermore, muscle activity and kinematic movement patterns will be expected to show more involved muscle groups and a walking pattern involving more degrees of freedom during use of the new version compared with the established Lokomat.
Exploratory endpoints will be a significantly stronger involvement of muscles needed for balance, more physiological walking patterns and more change on the lateral positioning of the feet due to training with the new version, compared with the established Lokomat.
- Conditions
- Post Stroke Gait Training
- Being tested
- Gait training with Lokomat Pro, Gait training with Lokomat Pro FreeD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with Lokomat ProBehavioural
Gait training with Lokomat Pro FreeDBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lokomat Pro | Active comparator | gait robot established on the market Receives: Behavioral: Gait training with Lokomat Pro |
| Lokomat Pro FreeD | Experimental | gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market Receives: Behavioral: Gait training with Lokomat Pro FreeD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral hip movement
during 30 min training with each device, lateral hip movements will be assessed
Measured: 30 min training during day 1 (next session after inclusion)
Secondary outcomes (2)
Patient satisfaction
Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
Measured: day 2 and 3
Patient motivation
Patient motivation, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
Measured: day 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: an additional intervention, amendet to the study (3rd arm, not described here), has not received clearance by regulatory authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Gait TrainingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cereneo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swiss Commission for Technology and Innovation, Swiss Federal Institute of Technology, Hocoma AG, University of Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189551
- Sponsor's protocol ID
- EKNZ: 2014-052
- Acronym
- LOKOMAT
- Status last verified
- Aug 2018
- First submitted
- 30 Jun 2014
- Last updated
- 15 Aug 2018
- Results posted
- No