Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System

Post Stroke Gait Training Clinical Trial

— LOKOMAT  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02189551
• Other study ID #: EKNZ: 2014-052
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2018
• Source: Cereneo AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Lower extremity weakness due to stroke

• minor functional impairment (MRC < 5)

• ability and willingness to participate

Exclusion Criteria:

• severe spasticity of the lower extremities

• severe dementia

• severe depression

• any other contraindications against Lokomat training

• body weight > 135 kg

Related Conditions & MeSH terms

• Post Stroke Gait Training

Intervention

Behavioral:
• Gait training with Lokomat Pro

• Gait training with Lokomat Pro FreeD

Locations

Country	Name	City	State
Switzerland	Cereneo, Center For Rehabilitation and Neurology	Vitznau	LU

Sponsors (5)

Lead Sponsor	Collaborator
Cereneo AG	Hocoma AG, Swiss Commission for Technology and Innovation, Swiss Federal Institute of Technology, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateral hip movement	during 30 min training with each device, lateral hip movements will be assessed	30 min training during day 1 (next session after inclusion)
Secondary	Patient satisfaction	Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).	day 2 and 3
Secondary	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).	day 2 and 3