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

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ClinicalTrials.gov Identifier: NCT02095795
Recruitment Status : Unknown
Verified March 2014 by Giovanni Taveggia, Habilita, Ospedale di Sarnico.
Recruitment status was:  Recruiting
First Posted : March 26, 2014
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Giovanni Taveggia, Habilita, Ospedale di Sarnico

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.


Condition or disease Intervention/treatment Phase
Stroke Device: Technological Rehabilitation Other: Control Rehabilitation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.
Study Start Date : March 2014
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Technological Rehabilitation
Patients in the experimental group received a multimodal treatment intervention consisting of 60 minutes of conventional treatment according to the Bobath approach (Bobath B. Adult hemiplegia: evaluation and treatment. Oxford: Butterworth-Heineman, 1990) followed by 30 minutes of robotic gait training on the Lokomat robotic system with the supervision of an expert rehabilitator. Patients started the first session with 50% weight unload and 1.5 Km/h gait speed, performances increments are allowed only in the following sessions. Each patient received 20 sessions over a period of 4 weeks (5 sessions per week).
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 Name: Lokomat

Active Comparator: Control Rehabilitation
Patients in the control group received the same number of treatment sessions of a similar duration as those in the experimental group but they received activities of overground walking exercises targeted to improve walking in substitution of the robotic gait trainer.
Other: Control Rehabilitation
When needed, more than one therapist are employed in the intervention for safety reasons.
Other Name: Manual rehabilitation with the therapist.




Primary Outcome Measures :
  1. Gait performances [ Time Frame: 1 day before the treatment ]

    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.


  2. Gait performances [ Time Frame: 1 day after the treatment ]

    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.


  3. Gait performances [ Time Frame: 60 days after the treatment ]

    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.



Secondary Outcome Measures :
  1. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Functional Ambulation Category (FAC)

  2. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Ashworth Scale

  3. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Functional Independence Measure (FIM)

  4. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Motricity Index Right

  5. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Motricity Index Left

  6. Functional outcomes [ Time Frame: 1 day before the treatment ]
    National Institute of Health Stroke Scale (NIHSS)

  7. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Numerical Rating Pain Scale

  8. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Quality of Life (SF36)

  9. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Tinetti Gait Test

  10. Functional outcomes [ Time Frame: 1 day before the treatment ]
    Tinetti Balance Test

  11. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Functional Ambulation Category (FAC)

  12. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Functional Ambulation Category (FAC)

  13. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Ashworth Scale

  14. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Ashworth Scale

  15. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Functional Independence Measure (FIM)

  16. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Functional Independence Measure (FIM)

  17. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Motricity Index Right

  18. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Motricity Index Right

  19. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Motricity Index Left

  20. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Motricity Index Left

  21. Functional outcomes [ Time Frame: 1 day after the treatment ]
    National Institute of Health Stroke Scale (NIHSS)

  22. Functional outcomes [ Time Frame: 60 days after the treatment ]
    National Institute of Health Stroke Scale (NIHSS)

  23. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Numerical Rating Pain Scale

  24. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Numerical Rating Pain Scale

  25. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Quality of Life (SF36)

  26. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Quality of Life (SF36)

  27. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Tinetti Gait Test

  28. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Tinetti Gait Test

  29. Functional outcomes [ Time Frame: 1 day after the treatment ]
    Tinetti Balance Test

  30. Functional outcomes [ Time Frame: 60 days after the treatment ]
    Tinetti Balance Test



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095795


Contacts
Contact: Stefania Fogliaresi, Coordinator +39035918 ext 293 stefaniafogliaresi@habilitasarnico.it
Contact: Paola Sabattini, Coordinator +39035481 ext 507 paolasabattini@habilita.it

Locations
Italy
Habilta Zingonia Recruiting
Ciserano, BG, Italy, 24040
Contact: Umberto Bonassi, Physician    +390354815 ext 662    umbertobonassi@habilita.it   
Sub-Investigator: Salvatore Missud, MD         
Habilita Sarnico Recruiting
Sarnico, BG, Italy, 24067
Contact: Giovanni Taveggia, Physician    +39035918 ext 234    giovannitaveggia@habilitasarnico.it   
Sub-Investigator: Chiara Mulé, MD         
Sponsors and Collaborators
Giovanni Taveggia
Investigators
Principal Investigator: Giovanni Taveggia, Physician Habilita, Ospedale di Sarnico

Responsible Party: Giovanni Taveggia, Medical Director, Habilita, Ospedale di Sarnico
ClinicalTrials.gov Identifier: NCT02095795     History of Changes
Other Study ID Numbers: Habilita-RAR-05
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Giovanni Taveggia, Habilita, Ospedale di Sarnico:
Exercise Therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases