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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Technological Rehabilitation
Control Rehabilitation
Sponsored by
Giovanni Taveggia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Exercise Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Habilta ZingoniaRecruiting
  • Habilita SarnicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technological Rehabilitation

Control Rehabilitation

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Functional outcomes
Functional Ambulation Category (FAC)
Functional outcomes
Ashworth Scale
Functional outcomes
Functional Independence Measure (FIM)
Functional outcomes
Motricity Index Right
Functional outcomes
Motricity Index Left
Functional outcomes
National Institute of Health Stroke Scale (NIHSS)
Functional outcomes
Numerical Rating Pain Scale
Functional outcomes
Quality of Life (SF36)
Functional outcomes
Tinetti Gait Test
Functional outcomes
Tinetti Balance Test
Functional outcomes
Functional Ambulation Category (FAC)
Functional outcomes
Functional Ambulation Category (FAC)
Functional outcomes
Ashworth Scale
Functional outcomes
Ashworth Scale
Functional outcomes
Functional Independence Measure (FIM)
Functional outcomes
Functional Independence Measure (FIM)
Functional outcomes
Motricity Index Right
Functional outcomes
Motricity Index Right
Functional outcomes
Motricity Index Left
Functional outcomes
Motricity Index Left
Functional outcomes
National Institute of Health Stroke Scale (NIHSS)
Functional outcomes
National Institute of Health Stroke Scale (NIHSS)
Functional outcomes
Numerical Rating Pain Scale
Functional outcomes
Numerical Rating Pain Scale
Functional outcomes
Quality of Life (SF36)
Functional outcomes
Quality of Life (SF36)
Functional outcomes
Tinetti Gait Test
Functional outcomes
Tinetti Gait Test
Functional outcomes
Tinetti Balance Test
Functional outcomes
Tinetti Balance Test

Full Information

First Posted
February 27, 2014
Last Updated
March 28, 2014
Sponsor
Giovanni Taveggia
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1. Study Identification

Unique Protocol Identification Number
NCT02095795
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Giovanni Taveggia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technological Rehabilitation
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Technological Rehabilitation
Other Intervention Name(s)
Lokomat
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Rehabilitation
Other Intervention Name(s)
Manual rehabilitation with the therapist.
Intervention Description
When needed, more than one therapist are employed in the intervention for safety reasons.
Primary Outcome Measure Information:
Title
Gait performances
Description
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.
Time Frame
1 day before the treatment
Title
Gait performances
Description
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.
Time Frame
1 day after the treatment
Title
Gait performances
Description
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.
Time Frame
60 days after the treatment
Secondary Outcome Measure Information:
Title
Functional outcomes
Description
Functional Ambulation Category (FAC)
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Ashworth Scale
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Functional Independence Measure (FIM)
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Motricity Index Right
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Motricity Index Left
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
National Institute of Health Stroke Scale (NIHSS)
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Numerical Rating Pain Scale
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Quality of Life (SF36)
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Tinetti Gait Test
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Tinetti Balance Test
Time Frame
1 day before the treatment
Title
Functional outcomes
Description
Functional Ambulation Category (FAC)
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Functional Ambulation Category (FAC)
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Ashworth Scale
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Ashworth Scale
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Functional Independence Measure (FIM)
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Functional Independence Measure (FIM)
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Motricity Index Right
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Motricity Index Right
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Motricity Index Left
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Motricity Index Left
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
National Institute of Health Stroke Scale (NIHSS)
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
National Institute of Health Stroke Scale (NIHSS)
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Numerical Rating Pain Scale
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Numerical Rating Pain Scale
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Quality of Life (SF36)
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Quality of Life (SF36)
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Tinetti Gait Test
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Tinetti Gait Test
Time Frame
60 days after the treatment
Title
Functional outcomes
Description
Tinetti Balance Test
Time Frame
1 day after the treatment
Title
Functional outcomes
Description
Tinetti Balance Test
Time Frame
60 days after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefania Fogliaresi, Coordinator
Phone
+39035918
Ext
293
Email
stefaniafogliaresi@habilitasarnico.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Sabattini, Coordinator
Phone
+39035481
Ext
507
Email
paolasabattini@habilita.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Taveggia, Physician
Organizational Affiliation
Habilita, Ospedale di Sarnico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Habilta Zingonia
City
Ciserano
State/Province
BG
ZIP/Postal Code
24040
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umberto Bonassi, Physician
Phone
+390354815
Ext
662
Email
umbertobonassi@habilita.it
First Name & Middle Initial & Last Name & Degree
Salvatore Missud, MD
Facility Name
Habilita Sarnico
City
Sarnico
State/Province
BG
ZIP/Postal Code
24067
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Taveggia, Physician
Phone
+39035918
Ext
234
Email
giovannitaveggia@habilitasarnico.it
First Name & Middle Initial & Last Name & Degree
Chiara Mulé, MD

12. IPD Sharing Statement

Learn more about this trial

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

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