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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02095795
• Other study ID #: Habilita-RAR-05
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2014
• Last updated: March 28, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: March 2014
• Source: Habilita, Ospedale di Sarnico
• Contact: Stefania Fogliaresi, Coordinator
• Phone: +39035918
• Email: stefaniafogliaresi[@]habilitasarnico.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Intervention

Device:
• Technological Rehabilitation
The Lokomat (Hocoma, Zurich, Switzerland) is robotic device conformed as an exoskeleton on the lower limbs of the patient. Through active and passive actuators, it realize a proper trajectory with an associated motion profile of the involved limbs. The results are physically guide repetitive, rhythmic, bilateral lower extremity movements in order to simulate a physiological gait cycle.The system uses a dynamic body weight-support system to support the participant above a motorized treadmill synchronized with the Lokomat. Participants were provided verbal encouragement to actively step in conjunction with the movement presented by the Lokomat.

Other:
• Control Rehabilitation
When needed, more than one therapist are employed in the intervention for safety reasons.

Locations

Country	Name	City	State
Italy	Habilta Zingonia	Ciserano	BG
Italy	Habilita Sarnico	Sarnico	BG

Sponsors (1)

Lead Sponsor	Collaborator
Giovanni Taveggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait performances	All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated.; The 6-Minute Walk Test (6MWT) and 10 meters walking test are used to assess endurance and speed, respectively. The 6MWT quantifies functional mobility based on the distance in meters traveled in 6 minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of stroke patients and are relevant for an autonomous life.; The speed is quantified with the 10-meters Walk Test (TWT) over the ground. The gait speed measurement is performed over the middle six meters of the TWT and patients are asked to walk at their comfortable speed.	1 day before the treatment	No
Primary	Gait performances	All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated.; The 6-Minute Walk Test (6MWT) and 10 meters walking test are used to assess endurance and speed, respectively. The 6MWT quantifies functional mobility based on the distance in meters traveled in 6 minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of stroke patients and are relevant for an autonomous life.; The speed is quantified with the 10-meters Walk Test (TWT) over the ground. The gait speed measurement is performed over the middle six meters of the TWT and patients are asked to walk at their comfortable speed.	1 day after the treatment	No
Primary	Gait performances	All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated.; The 6-Minute Walk Test (6MWT) and 10 meters walking test are used to assess endurance and speed, respectively. The 6MWT quantifies functional mobility based on the distance in meters traveled in 6 minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of stroke patients and are relevant for an autonomous life.; The speed is quantified with the 10-meters Walk Test (TWT) over the ground. The gait speed measurement is performed over the middle six meters of the TWT and patients are asked to walk at their comfortable speed.	60 days after the treatment	No
Secondary	Functional outcomes	Functional Ambulation Category (FAC)	1 day before the treatment	No
Secondary	Functional outcomes	Ashworth Scale	1 day before the treatment	No
Secondary	Functional outcomes	Functional Independence Measure (FIM)	1 day before the treatment	No
Secondary	Functional outcomes	Motricity Index Right	1 day before the treatment	No
Secondary	Functional outcomes	Motricity Index Left	1 day before the treatment	No
Secondary	Functional outcomes	National Institute of Health Stroke Scale (NIHSS)	1 day before the treatment	No
Secondary	Functional outcomes	Numerical Rating Pain Scale	1 day before the treatment	No
Secondary	Functional outcomes	Quality of Life (SF36)	1 day before the treatment	No
Secondary	Functional outcomes	Tinetti Gait Test	1 day before the treatment	No
Secondary	Functional outcomes	Tinetti Balance Test	1 day before the treatment	No
Secondary	Functional outcomes	Functional Ambulation Category (FAC)	1 day after the treatment	No
Secondary	Functional outcomes	Functional Ambulation Category (FAC)	60 days after the treatment	No
Secondary	Functional outcomes	Ashworth Scale	1 day after the treatment	No
Secondary	Functional outcomes	Ashworth Scale	60 days after the treatment	No
Secondary	Functional outcomes	Functional Independence Measure (FIM)	1 day after the treatment	No
Secondary	Functional outcomes	Functional Independence Measure (FIM)	60 days after the treatment	No
Secondary	Functional outcomes	Motricity Index Right	1 day after the treatment	No
Secondary	Functional outcomes	Motricity Index Right	60 days after the treatment	No
Secondary	Functional outcomes	Motricity Index Left	1 day after the treatment	No
Secondary	Functional outcomes	Motricity Index Left	60 days after the treatment	No
Secondary	Functional outcomes	National Institute of Health Stroke Scale (NIHSS)	1 day after the treatment	No
Secondary	Functional outcomes	National Institute of Health Stroke Scale (NIHSS)	60 days after the treatment	No
Secondary	Functional outcomes	Numerical Rating Pain Scale	1 day after the treatment	No
Secondary	Functional outcomes	Numerical Rating Pain Scale	60 days after the treatment	No
Secondary	Functional outcomes	Quality of Life (SF36)	1 day after the treatment	No
Secondary	Functional outcomes	Quality of Life (SF36)	60 days after the treatment	No
Secondary	Functional outcomes	Tinetti Gait Test	1 day after the treatment	No
Secondary	Functional outcomes	Tinetti Gait Test	60 days after the treatment	No
Secondary	Functional outcomes	Tinetti Balance Test	1 day after the treatment	No
Secondary	Functional outcomes	Tinetti Balance Test	60 days after the treatment	No