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

Cereneo

Status: Terminated

Conditions: Post Stroke Gait Training

Treatments: Behavioral: Gait training with Lokomat Pro; Behavioral: Gait training with Lokomat Pro FreeD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02189551

EKNZ: 2014-052

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Lokomat Pro

Active Comparator group

Description:

gait robot established on the market

Treatment:

Behavioral: Gait training with Lokomat Pro

Lokomat Pro FreeD

Experimental group

Description:

gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market

Treatment:

Behavioral: Gait training with Lokomat Pro FreeD