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

Not Applicable

Terminated

• Conditions: Post Stroke Gait Training

• Registration Number: NCT02189551
• Lead Sponsor: Cereneo AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lateral hip movement	30 min training during day 1 (next session after inclusion)	during 30 min training with each device, lateral hip movements will be assessed

Secondary Outcome Measures

Name	Time	Method
Patient motivation	day 2 and 3	Patient motivation, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).
Patient satisfaction	day 2 and 3	Satisfaction, based on questionnaires, will be assessed after training with the experimental and the standard device in two consecutive sessions (randomized order).

Trial Locations

Locations (1)

Cereneo, Center For Rehabilitation and Neurology; 🇨🇭 Vitznau, LU, Switzerland