StrokePhase 2NCT01395576
Evaluation of the Genu Neurexa Orthosis in Post Stroke Patients
A Phase 2 study testing Genu Neurexa orthosis in people with Stroke, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Post stroke patients often suffer from decrease in strength, loss of balance and gait asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury. The presence of spastic or retracted muscles, e.g. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Genu Neurexa orthosis
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Apr 2014
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering a first stro(at least 3 months post stroke)
- Cognitive and cooperative ability to follo instructions.
- Patients suffering from paresis of leg muscles resulting in knee hyperextension.
- Ability to walk with or without a walking aid (cane, walker) independently
Who cannot join
- Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
- Skin disease or wounds at the paretic knee
- Ankle or foot contructure or limited range of motion
- Orthopaedic injury to the paretic or non-paretic limbs
Trial locations and contacts
1 site in 1 country.
About this study
Post stroke patients often suffer from decrease in strength, loss of balance and gait asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury. The presence of spastic or retracted muscles, e.g. the ankle plantar flexors or the quadriceps in combination with hamstrings weakness, causes knee hyperextension, which increases the stance phase duration and makes it difficult to achieve symmetrical gait. Additionally, this gait disorder can be painful as a result of stress to the ligaments and tendons at the posterior aspect of the knee.
The Genu Neurexa orthosis is designed to stabilize the knee, enable balance control and prevent hyperextension. In order to assess the effect of the orthosis on the gait and balance characteristics of stroke patients the investigators will conduct subjective patient's satisfactory questionnaire, complete physical and functional evaluation and gait analysis, as well as dynamic electromyography (EMG) muscle activation patterns. These examinations will be performed 3 times: at the beginning of the trial, after one month and after two months. The trial design is explained in the following paragraph.
The investigators hypothesize that the gait pattern will be improved while using the knee orthosis,as will be expressed by smaller base width and faster walking velocity etc.
Read the detailed description
The 8-week prospective, randomized controlled study design is depicted in Figure 1. The subjects will be randomly divided into two groups: group A (n=30) or group B (n=30). The patients will be randomly assigned to the study groups , using a block sampling method. The gait pattern, symmetry, and balance of each subject will be evaluated according to the tests described below. After the initial evaluation, group A will be fitted with the Genu Neurexa orthosis for the first four weeks of the study. Group B will not receive treatment for the first four weeks of the study. The subjects will be retested after 4 weeks. Then, group A will ambulate without the Genu Neurexa orthosis for the last 4 weeks. Group B will receive the Genu Neurexa orthosis for the last 4 weeks of the study. Both groups will be retested after 8 weeks for the time of enrollment. This design will provide intra-subject and inter-subject comparison.
The evaluation protocol:
The evaluation tools include subjective patient's satisfactory questionnaire, complete physical and functional evaluation and gait analysis (spatio-temporal parameters and paretic knee angle in the sagittal plane), as well as dynamic electromyography (EMG) muscle activation patterns. The evaluation tools are detailed below.
Gait analysis will be performed while subjects walk on a 6m-long walking path. First, video-recorded observational analysis through the coronal and sagittal planes will be performed in order to register the overall walking pattern and compensation mechanisms.
The main outcome measures will be spatiotemporal parameters (stride time, step time, stance duration, swing duration, double support duration, stride length, step length, base width, toe out angle, cadence and velocity) acquired using 4 markers.
Two-dimensional kinematics examination will be conducted using three markers, located on the paretic limb, in order to measure exact knee angle in the sagittal plane.
The subjects will be instructed to walk several times at their chosen speed on the path, while 4 cameras record the location of the markers. Post analyses, composed of marker identification and tracking (using commercial software by Simi Reality Motion Systems, Germany) and calculations of spatiotemporal parameters, will not be performed in the presence of the subject.
Finally, surface EMG electrodes will be attached to 3 muscles on each leg for dynamic evaluation of dynamic muscle activation pattern during gait. Specifically, we will monitor the gastrocnemius, soleus, and rectus femoris in each leg.
Complete physical evaluation will be conducted to assess range of motion of the joints and muscle tonus.
Functional evaluation of each subject will be accomplished using the Six-Minute Walk Test (6MWT), 10-meter walk test, timed-up-and-go test (TUG) and Berg balance scale (BBS). The BBS is a 14-item scale, designed to measure balance in the clinical setting.
- Conditions
- Stroke
- Being tested
- Genu Neurexa orthosis
- Keywords
- Genu recurvatum, Knee hyper extension, Orthosis, Gait analysis, Post stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genu Neurexa orthosisDevice
Knee orthosis for the prevention of knee hyper extension
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal parameters
stride time, step time, stance duration, swing duration, double support duration, stride length, step length, base width, toe out angle, cadence and velocity
Measured: Up to 3 months
Secondary outcomes (3)
Dynamic EMG recordings
Surface EMG electrodes will be attached to 3 muscles on each leg for dynamic evaluation of dynamic muscle activation pattern during gait. Specifically, we will monitor the gastrocnemius, soleus, and rectus femoris in each leg
Measured: Up to 3 months
Sagittal angle of the paretic knee
Sagittal angle of the paretic knee
Measured: Up to 3 months
Functional evaluation
Functional evaluation of each subject will be accomplished using the Six-Minute Walk Test (6MWT), 10-meter walk test, timed-up-and-go test (TUG) and Berg balance scale (BBS). The BBS is a 14-item scale, designed to measure balance in the clinical setting
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: statistical significance of the results was reached for the 34 subjects who participated in teh study.
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.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395576
- Sponsor's protocol ID
- GENU-HMO-CTIL
- Status last verified
- Oct 2012
- First submitted
- 3 Jul 2011
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Genu Neurexa Orthosis in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT01395576
- Acronym / sponsor ID
- GENU-HMO-CTIL
- Conditions
- Stroke
- Keywords
- Genu recurvatum, Knee hyper extension, Orthosis, Gait analysis, Post stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: statistical significance of the results was reached for the 34 subjects who participated in teh study.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Jul 2011 (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.
Post stroke patients often suffer from decrease in strength, loss of balance and gait asymmetry. Accordingly, these patients are at high risk for falls and fall-related injury. The presence of spastic or retracted muscles, e.g. the ankle plantar flexors or the quadriceps in combination with hamstrings weakness, causes knee hyperextension, which increases the stance phase duration and makes it difficult to achieve symmetrical gait. Additionally, this gait disorder can be painful as a result of stress to the ligaments and tendons at the posterior aspect of the knee.
The Genu Neurexa orthosis is designed to stabilize the knee, enable balance control and prevent hyperextension. In order to assess the effect of the orthosis on the gait and balance characteristics of stroke patients the investigators will conduct subjective patient's satisfactory questionnaire, complete physical and functional evaluation and gait analysis, as well as dynamic electromyography (EMG) muscle activation patterns. These examinations will be performed 3 times: at the beginning of the trial, after one month and after two months. The trial design is explained in the following paragraph.
The investigators hypothesize that the gait pattern will be improved while using the knee orthosis,as will be expressed by smaller base width and faster walking velocity etc.
Detailed description
The 8-week prospective, randomized controlled study design is depicted in Figure 1. The subjects will be randomly divided into two groups: group A (n=30) or group B (n=30). The patients will be randomly assigned to the study groups , using a block sampling method. The gait pattern, symmetry, and balance of each subject will be evaluated according to the tests described below. After the initial evaluation, group A will be fitted with the Genu Neurexa orthosis for the first four weeks of the study. Group B will not receive treatment for the first four weeks of the study. The subjects will be retested after 4 weeks. Then, group A will ambulate without the Genu Neurexa orthosis for the last 4 weeks. Group B will receive the Genu Neurexa orthosis for the last 4 weeks of the study. Both groups will be retested after 8 weeks for the time of enrollment. This design will provide intra-subject and inter-subject comparison.
The evaluation protocol:
The evaluation tools include subjective patient's satisfactory questionnaire, complete physical and functional evaluation and gait analysis (spatio-temporal parameters and paretic knee angle in the sagittal plane), as well as dynamic electromyography (EMG) muscle activation patterns. The evaluation tools are detailed below.
Gait analysis will be performed while subjects walk on a 6m-long walking path. First, video-recorded observational analysis through the coronal and sagittal planes will be performed in order to register the overall walking pattern and compensation mechanisms.
The main outcome measures will be spatiotemporal parameters (stride time, step time, stance duration, swing duration, double support duration, stride length, step length, base width, toe out angle, cadence and velocity) acquired using 4 markers.
Two-dimensional kinematics examination will be conducted using three markers, located on the paretic limb, in order to measure exact knee angle in the sagittal plane.
The subjects will be instructed to walk several times at their chosen speed on the path, while 4 cameras record the location of the markers. Post analyses, composed of marker identification and tracking (using commercial software by Simi Reality Motion Systems, Germany) and calculations of spatiotemporal parameters, will not be performed in the presence of the subject.
Finally, surface EMG electrodes will be attached to 3 muscles on each leg for dynamic evaluation of dynamic muscle activation pattern during gait. Specifically, we will monitor the gastrocnemius, soleus, and rectus femoris in each leg.
Complete physical evaluation will be conducted to assess range of motion of the joints and muscle tonus.
Functional evaluation of each subject will be accomplished using the Six-Minute Walk Test (6MWT), 10-meter walk test, timed-up-and-go test (TUG) and Berg balance scale (BBS). The BBS is a 14-item scale, designed to measure balance in the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering a first stro(at least 3 months post stroke)
- Cognitive and cooperative ability to follo instructions.
- Patients suffering from paresis of leg muscles resulting in knee hyperextension.
- Ability to walk with or without a walking aid (cane, walker) independently
Key exclusion criteria (4 listed)
- Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
- Skin disease or wounds at the paretic knee
- Ankle or foot contructure or limited range of motion
- Orthopaedic injury to the paretic or non-paretic limbs
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 |
|---|---|---|
| Genu Neurexa orthosisKnee orthosis for the prevention of knee hyper extension | Device | – |
Primary outcome
Spatiotemporal parameters
Time frame: Up to 3 months
stride time, step time, stance duration, swing duration, double support duration, stride length, step length, base width, toe out angle, cadence and velocity
3 secondary outcomes
Dynamic EMG recordings
Time frame: Up to 3 months
Sagittal angle of the paretic knee
Time frame: Up to 3 months
Functional evaluation
Time frame: Up to 3 months
Results and safety
The study was stopped early (reason given: statistical significance of the results was reached for the 34 subjects who participated in teh study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genu Neurexa orthosis in people with Stroke, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: statistical significance of the results was reached for the 34 subjects who participated in teh study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatiotemporal parameters (time frame: Up to 3 months). 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 20 May 2014.