StrokeNCT02095795
Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.
A study testing Technological Rehabilitation in people with Stroke, run by Giovanni Taveggia at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Technological Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2014to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiparesis at least six months from stroke.
Who cannot join
- 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)
Show all 10Show fewer
- Cutaneous lesions at lower limbs
- Weight > 135 kg
- Height > 200 cm
- Dysmetria of lower limbs more than 2 cm
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Habilta Zingonia
Ciserano, BG, 24040
Umberto Bonassi, Physician, +390354815 ext. 662, umbertobonassi@habilita.it
Salvatore Missud, MD
- Recruiting
Habilita Sarnico
Sarnico, BG, 24067
Giovanni Taveggia, Physician, +39035918 ext. 234, giovannitaveggia@habilitasarnico.it
Chiara Mulé, MD
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Technological Rehabilitation, Control Rehabilitation
- Keywords
- Exercise Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological RehabilitationDevice
Also called Lokomat
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.
Control RehabilitationOther
Also called Manual rehabilitation with the therapist.
When needed, more than one therapist are employed in the intervention for safety reasons.
| Study group | Role | What they receive |
|---|---|---|
| Technological Rehabilitation | Experimental | 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). Receives: Device: Technological Rehabilitation |
| Control Rehabilitation | Active comparator | 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. Receives: Other: Control Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day before the treatment
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.
Measured: 1 day after the treatment
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.
Measured: 60 days after the treatment
Secondary outcomes (30)
Functional outcomes
Functional Ambulation Category (FAC)
Measured: 1 day before the treatment
Functional outcomes
Ashworth Scale
Measured: 1 day before the treatment
Functional outcomes
Functional Independence Measure (FIM)
Measured: 1 day before the treatment
Functional outcomes
Motricity Index Right
Measured: 1 day before the treatment
Functional outcomes
Motricity Index Left
Measured: 1 day before the treatment
Functional outcomes
National Institute of Health Stroke Scale (NIHSS)
Measured: 1 day before the treatment
Functional outcomes
Numerical Rating Pain Scale
Measured: 1 day before the treatment
Functional outcomes
Quality of Life (SF36)
Measured: 1 day before the treatment
Functional outcomes
Tinetti Gait Test
Measured: 1 day before the treatment
Functional outcomes
Tinetti Balance Test
Measured: 1 day before the treatment
Functional outcomes
Functional Ambulation Category (FAC)
Measured: 1 day after the treatment
Functional outcomes
Functional Ambulation Category (FAC)
Measured: 60 days after the treatment
Functional outcomes
Ashworth Scale
Measured: 1 day after the treatment
Functional outcomes
Ashworth Scale
Measured: 60 days after the treatment
Functional outcomes
Functional Independence Measure (FIM)
Measured: 1 day after the treatment
Functional outcomes
Functional Independence Measure (FIM)
Measured: 60 days after the treatment
Functional outcomes
Motricity Index Right
Measured: 1 day after the treatment
Functional outcomes
Motricity Index Right
Measured: 60 days after the treatment
Functional outcomes
Motricity Index Left
Measured: 1 day after the treatment
Functional outcomes
Motricity Index Left
Measured: 60 days after the treatment
Functional outcomes
National Institute of Health Stroke Scale (NIHSS)
Measured: 1 day after the treatment
Functional outcomes
National Institute of Health Stroke Scale (NIHSS)
Measured: 60 days after the treatment
Functional outcomes
Numerical Rating Pain Scale
Measured: 1 day after the treatment
Functional outcomes
Numerical Rating Pain Scale
Measured: 60 days after the treatment
Functional outcomes
Quality of Life (SF36)
Measured: 1 day after the treatment
Functional outcomes
Quality of Life (SF36)
Measured: 60 days after the treatment
Functional outcomes
Tinetti Gait Test
Measured: 1 day after the treatment
Functional outcomes
Tinetti Gait Test
Measured: 60 days after the treatment
Functional outcomes
Tinetti Balance Test
Measured: 1 day after the treatment
Functional outcomes
Tinetti Balance Test
Measured: 60 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giovanni Taveggia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giovanni Taveggia, Habilita, Ospedale di Sarnico
- Investigators
- Giovanni Taveggia, Physician, Principal investigator, Habilita, Ospedale di Sarnico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095795
- Sponsor's protocol ID
- Habilita-RAR-05
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exoskeleton Gait Training Versus Manual Therapy in Subacute Post Stroke Patients.
- ClinicalTrials.gov ID
- NCT02095795
- Acronym / sponsor ID
- Habilita-RAR-05
- Conditions
- Stroke
- Keywords
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Giovanni TaveggiaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technological Rehabilitation | Experimental | Device: Technological RehabilitationPatients 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). |
| Control Rehabilitation | Active comparator | Other: Control RehabilitationPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemiparesis at least six months from stroke.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technological RehabilitationAlso: LokomatThe 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. | Device | Technological Rehabilitation |
| Control RehabilitationAlso: Manual rehabilitation with the therapist.When needed, more than one therapist are employed in the intervention for safety reasons. | Other | Control Rehabilitation |
Primary outcome
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.
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.
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.
30 secondary outcomes
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day before the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Functional outcomes
Time frame: 1 day after the treatment
Functional outcomes
Time frame: 60 days after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Taveggia, Physician principal investigator
Habilita, Ospedale di Sarnico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological Rehabilitation in people with Stroke, run by Giovanni Taveggia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Fogliaresi, Coordinator (+39035918 ext. 293, stefaniafogliaresi@habilitasarnico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait performances (time frame: 1 day before the treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.