Clinical trial NCT02095795: Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.
Official title: Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Exercise Therapy
Lead sponsor: Habilita, Ospedale di Sarnico
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* hemiparesis at least six months from stroke.

Exclusion Criteria:

* Ashworth scale \>3
* Bone instability (unconsolidated fractures, vertebral instability, severe osteoporosis),
* Articular ankyloses, contractures
* Spasms with locomotion effects
* Mini Mental State Examination (MMSE) \[???\] \< 22 points and behavioral diseases involving aggressivity or psychotic disorders
* Clinicopathological conditions contraindicating the rehabilitation treatment (respiratory insufficiency, cardiac/circulatory failure, osteomyelitis, phlebitis and other conditions)
* Cutaneous lesions at lower limbs
* Weight \> 135 kg
* Height \> 200 cm
* Dysmetria of lower limbs more than 2 cm

Primary outcomes:
measure: Gait performances
timeFrame: 1 day before the treatment
measure: Gait performances
timeFrame: 1 day after the treatment
measure: Gait performances
timeFrame: 60 days after the treatment
Secondary outcomes:
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day before the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
measure: Functional outcomes
timeFrame: 1 day after the treatment
measure: Functional outcomes
timeFrame: 60 days after the treatment
Other outcomes:
Locations:
city: Ciserano
country: Italy
facility: Habilta Zingonia
state: BG
city: Sarnico
country: Italy
facility: Habilita Sarnico
state: BG
Study officials:
affiliation: Habilita, Ospedale di Sarnico
name: Giovanni Taveggia, Physician
role: PRINCIPAL_INVESTIGATOR
References: