Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.

Stroke Clinical Trial

Official title: Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.

Status Recruiting

Clinical Trial Summary

The main objective of the present study was to compare the effects of exoskeleton devices used in electromechanical-assisted gait training after stroke compared to over ground conventional physical therapy in a single blind research.

The second objective is to research when the devices can be used with the best chance of success in the functional recovery of gait in people who are unable to walk independently after stroke.

Clinical Trial Description

Stroke is the leading cause of death and of serious long term disability in adults, three mouths after stroke, 20% of people remain wheelchair bound, and 70% walk at reduced velocity and capacity.

People who suffer a stroke, when regain ambulatory function, walk with typically asymmetrical gait pattern, slow, and metabolically inefficient. These characteristics are associated with difficulty advancing and bearing weight though the more affected limb, leading to instability and increased risk of falls.

Manually-assisted body-weight supported Treadmill training (BWSTT) is a contemporary approach to gait rehabilitation after stroke, whereas an individual walks on a treadmill, the therapists manually facilitate hemiparetic limb and trunk control in an effort to normalize upright reciprocal stepping and dynamic postural control. Advantages of this approach are that little to no ambulatory function is required to initiate locomotion and early post stroke training effects are transferred of improvements in over ground gait including: symmetry, speed, and endurance as well as motor impairment and balance scores.

An example of electromechanical devices is Lokomat, a robotic gait orthosis combined with harness-supported body weight system is used together with a treadmill. However the main difference from treadmill training is that the patient's legs are guided by the robotic device according to a preprogrammed gait pattern. A computer-controlled robotic gait orthosis guides the patient, and the process of gait training in automated.

Lokomat can be used to give non ambulatory patients intensive practice in terms of high repetitions, of complex gait cycles with a reduced effort for therapists, as they no longer need to set the paretic limbs or assist trunk movements.

The main objective of the present study was to compare the effects of exoskeleton devices used in electromechanical-assisted gait training after stroke compared to over ground conventional physical therapy in a single blind research.

The second objective is to research when the devices can be used with the best chance of success in the functional recovery of gait in people who are unable to walk independently after stroke. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT02095795
• Study type: Interventional
• Source: Habilita, Ospedale di Sarnico
• Contact: Stefania Fogliaresi, Coordinator
• Phone: +39035918
• Email: stefaniafogliaresi@habilitasarnico.it
• Status: Recruiting
• Phase: N/A
• Start date: March 2014
• Completion date: May 2014