Motor ImpairmentsNCT01631604
Gait Characteristics Following a Fall
A study testing Walking aids and devices, Muscle/nerve injection and Corrective surgery in people with Motor Impairments and Orthopaedic Injuries, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motor Impairments, Orthopaedic Injuries, Neurological Conditions
- What is being tested?
- Walking aids and devices, Muscle/nerve injection and Corrective surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Jun 2017
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.
Who cannot join
- Subjects who are unable to understand and independently sign a consent form
- Subjects who are wheelchair bound.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Gait Parameters and Muscle Activation Patterns Following a Fall
The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.
Read the detailed description
In this study, patients suffering from motor disabilities as a result of orthopedic or neurologic impairments will be tested at the gait and motion laboratory. Each patient will be secured with a ceiling-mounted safety harness and will walk on the path wearing passive light-reflecting markers and surface electrodes. High-speed cameras will record the subject's movements and the markers will be tracked to produce data of joint angles, velocities and accelerations. Dynamic EMG will be recorded from various muscles.
During the examination, the gait of the subjects will be disturb by either (i) a visual or sound signal that requires the subject to stop immediately, or (ii) walking different terrains, or (iii) tying a string to the foot and pulling it shortly to induce a trip.
- Being tested
- Walking aids and devices, Muscle/nerve injection, Corrective surgery, Physical therapy treatment
- Keywords
- risk of falling, gait patterns, muscle activity, fall prevention, motor impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking aids and devicesDevice
Walking aids, e.g. braces, canes,orthoses, prosthetics, etc.
Muscle/nerve injectionDrug
Also called Botulinum toxin, Marcaine
Injection to muscle or nerve
Corrective surgeryProcedure or surgery
Also called Knee arthroscopy, meniscectomy and chondroplasty, Anterior cruciate ligament reconstruction, Knee replacement, Repair of femoral neck fracture
correction of spinal and bony deformities, muscle transfer, tendon elongation etc.
Physical therapy treatmentOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait kinematics
Joint angles, velocities and accelerations
Secondary outcomes (1)
Muscle activation patterns
Dynamic EMG of various muscles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ImpairmentsStudies 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
- Intervention model
- Factorial
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631604
- Sponsor's protocol ID
- Fall-HMO-CTIL
- Status last verified
- Jun 2012
- First submitted
- 28 Jun 2012
- Last updated
- 27 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Gait Parameters and Muscle Activation Patterns Following a Fall
- ClinicalTrials.gov ID
- NCT01631604
- Acronym / sponsor ID
- Fall-HMO-CTIL
- Keywords
- risk of falling, gait patterns, muscle activity, fall prevention, motor impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Jun 2012 (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 purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.
Detailed description
In this study, patients suffering from motor disabilities as a result of orthopedic or neurologic impairments will be tested at the gait and motion laboratory. Each patient will be secured with a ceiling-mounted safety harness and will walk on the path wearing passive light-reflecting markers and surface electrodes. High-speed cameras will record the subject's movements and the markers will be tracked to produce data of joint angles, velocities and accelerations. Dynamic EMG will be recorded from various muscles.
During the examination, the gait of the subjects will be disturb by either (i) a visual or sound signal that requires the subject to stop immediately, or (ii) walking different terrains, or (iii) tying a string to the foot and pulling it shortly to induce a trip.
Study design
- Primary purpose
- Treatment
- Intervention model
- Factorial
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.
Key exclusion criteria (3 listed)
- Subjects who are unable to understand and independently sign a consent form
- Subjects who are wheelchair bound.
- Pregnant women.
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 |
|---|---|---|
| Walking aids and devicesWalking aids, e.g. braces, canes,orthoses, prosthetics, etc. | Device | – |
| Muscle/nerve injectionAlso: Botulinum toxin, MarcaineInjection to muscle or nerve | Drug | – |
| Corrective surgeryAlso: Knee arthroscopy, meniscectomy and chondroplasty, Anterior cruciate ligament reconstruction, Knee replacement, Repair of femoral neck fracturecorrection of spinal and bony deformities, muscle transfer, tendon elongation etc. | Procedure or surgery | – |
| Physical therapy treatment | Other | – |
Primary outcome
Gait kinematics
Joint angles, velocities and accelerations
1 secondary outcome
Muscle activation patterns
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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 study testing Walking aids and devices, Muscle/nerve injection and Corrective surgery in people with Motor Impairments and Orthopaedic Injuries, 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 1 inclusion and 3 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 27 Apr 2017. 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.
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?
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?
Gait kinematics. 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 27 Apr 2017.