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Integrated, Practice-oriented Electromechanical-assisted Gait Training in Subacute Stroke Patients

NCT03463746 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-03-13

No results posted yet for this study

Summary

Background and Rationale:

Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious rehabilitation programs 70% of those stroke patients still show limited gait ability after three months.

Numerous RCTs have shown the superiority of over ground gait training and electromechanical-assisted gait devices in comparison with conventional over ground gait training alone. (Jan Mehrholz, Elsner, Werner, Kugler, \& Pohl, 2013) However, most of these trials used the electromechanical-assisted gait devices in a very high frequency which is almost impossible to achieve in daily clinical routine. Therefore, the effect of a practice-oriented physical therapy protocol including electromechanical-assisted gait training remains unclear.

Objective(s):

The aim of this clinical trial is to investigate the effects of an integrated, practice-orientated individual physical therapy protocol with or without electromechanical-assisted gait training in subacute stroke patients, respectively.

The effects of both physical therapy protocols will be compared with validated assessments covering the different components of the ICF framework: function, activity and participation.

Primary objectives: Effects on gait ability and on basic activities of daily living (ADL).

Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle force, spasticity and reintegration to normal living (RNLI).

Furthermore, different training-related data are recorded to capture the efficiency (intensity and hassle) of both physical therapy protocols.

Conditions

Interventions

DEVICE

LYRA® gait trainer

The EG will get standard individual physical therapy (5x/week, 45min) whereby three sessions of electromechanical-assisted gait training on LYRA® gait trainer.

DEVICE

Standard individual physical therapy

The CG will get standard individual physical therapy (5x/week, 45min) without any instrument-based locomotion therapy (i.e. treadmill training, electromechanical/robot-assisted gait training).

Sponsors & Collaborators

  • Zürcher RehaZentrum Wald

    lead OTHER

Principal Investigators

  • Antonella Palla, MD · Züricher RehaZentrum Wald

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-13
Primary Completion
2020-03-31
Completion
2020-06-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463746 on ClinicalTrials.gov