Gait Disorder, SensorimotorNCT02310841
Pilot Study for Patient-cooperative Control Strategies for Actuated Transfemoral Prostheses
A study testing ANGELAA in people with Gait Disorder, Sensorimotor, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
This pilot study investigates the feasibility of novel control strategies for actuated transfemoral prostheses. Several parameters from gait analysis (including motion-capture and ground reaction force measurements) are analyzed. The subjective perception of prosthetic functionality is captured with a questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait Disorder, Sensorimotor
- What is being tested?
- ANGELAA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Feb 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Written consent of participant
- For amputees: regular use of a transfemoral prosthesis
- For amputees: transfemoral amputation
Who cannot join
- Bodymass > 100 kg
- For amputees: mobility class 1
- For amputees: no stable residual leg volume
- For amputees: constrictive contractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilotstudie zu Patientenkooperativen Regelungsstrategien für Aktuierte Oberschenkelexoprothesen
This pilot study investigates the feasibility of novel control strategies for actuated transfemoral prostheses. Several parameters from gait analysis (including motion-capture and ground reaction force measurements) are analyzed. The subjective perception of prosthetic functionality is captured with a questionnaire.
Read the detailed description
Setting of the study: Conventional prostheses for transfemoral amputees are mostly simple mechanic joints, or have micro-processor-controlled damping. The prototype tested in this study is equipped with a motor that can actively move the knee joint. Therefore, movements like, for example, alternating stair climbing, are possible that cannot be realized with pure mechanical and actively damped prostheses. During level-ground walking, it is hypothesized that less compensatory movements are needed. We have developed an actuated prototypical prosthesis and new control strategies which should facilitate both level-ground walking and stair climbing. Parts of the control strategies have been tested in able-bodied subjects [1]. This control strategy has been extended such that only biological stiffness modulation can be rendered [2].
Hypothesis: Subjects can use our transfemoral prosthesis to walk on level-ground, to climb several steps and to overcome small obstacles without prior training. The user-cooperative control is intuitive and easily learnable.
Objective of the study: This pilot study is meant to investigate the general feasibility of novel control strategies for actuated transfemoral prostheses. Parameters of a standard gait analysis, like ground reaction forces and kinematics (using a motion capture system), will be recorded. From this data, gait symmetry, step length, walking speed, and other measures can be calculated. The subjective impression of the user will be evaluated with a questionnaire.
- Conditions
- Gait Disorder, Sensorimotor
- Being tested
- ANGELAA
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANGELAADevice
Different control strategies with transfemoral prosthesis prototype ANGELAA, developed at the Sensory-Motor Systems Lab, ETH Zurich, not commercially available, only 1 device exists
| Study group | Role | What they receive |
|---|---|---|
| unilateral transfemoral amputees | Experimental | Not described Receives: Device: ANGELAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gait pattern using an actuated transfemoral prosthesis compared to a passive prosthesis
Measured: Subjects will come to the gait lab for two days. The experiment itself lasts about 1.5 hours per day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorder, SensorimotorStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist University Hospital
- Responsible party
- Principal investigator, Verena Klamroth, Swiss Federal Institute of Technology
- Investigators
- Robert Riener, Prof. Dr, Principal investigator, Sensory Motor Systems Lab, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310841
- Sponsor's protocol ID
- KEK-ZH-2013-0034
- Other IDs
- 2013-MD-0004
- Status last verified
- Dec 2014
- First submitted
- 29 Oct 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilotstudie zu Patientenkooperativen Regelungsstrategien für Aktuierte Oberschenkelexoprothesen
- ClinicalTrials.gov ID
- NCT02310841
- Acronym / sponsor ID
- KEK-ZH-2013-0034
- Conditions
- Gait Disorder, Sensorimotor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Balgrist University Hospital
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Dec 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.
This pilot study investigates the feasibility of novel control strategies for actuated transfemoral prostheses. Several parameters from gait analysis (including motion-capture and ground reaction force measurements) are analyzed. The subjective perception of prosthetic functionality is captured with a questionnaire.
Detailed description
Setting of the study: Conventional prostheses for transfemoral amputees are mostly simple mechanic joints, or have micro-processor-controlled damping. The prototype tested in this study is equipped with a motor that can actively move the knee joint. Therefore, movements like, for example, alternating stair climbing, are possible that cannot be realized with pure mechanical and actively damped prostheses. During level-ground walking, it is hypothesized that less compensatory movements are needed. We have developed an actuated prototypical prosthesis and new control strategies which should facilitate both level-ground walking and stair climbing. Parts of the control strategies have been tested in able-bodied subjects [1]. This control strategy has been extended such that only biological stiffness modulation can be rendered [2].
Hypothesis: Subjects can use our transfemoral prosthesis to walk on level-ground, to climb several steps and to overcome small obstacles without prior training. The user-cooperative control is intuitive and easily learnable.
Objective of the study: This pilot study is meant to investigate the general feasibility of novel control strategies for actuated transfemoral prostheses. Parameters of a standard gait analysis, like ground reaction forces and kinematics (using a motion capture system), will be recorded. From this data, gait symmetry, step length, walking speed, and other measures can be calculated. The subjective impression of the user will be evaluated with a questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unilateral transfemoral amputees | Experimental | Device: ANGELAA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Written consent of participant
- For amputees: regular use of a transfemoral prosthesis
- For amputees: transfemoral amputation
Key exclusion criteria (4 listed)
- Bodymass > 100 kg
- For amputees: mobility class 1
- For amputees: no stable residual leg volume
- For amputees: constrictive contractures
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 |
|---|---|---|
| ANGELAADifferent control strategies with transfemoral prosthesis prototype ANGELAA, developed at the Sensory-Motor Systems Lab, ETH Zurich, not commercially available, only 1 device exists | Device | unilateral transfemoral amputees |
Primary outcome
Change of gait pattern using an actuated transfemoral prosthesis compared to a passive prosthesis
Time frame: Subjects will come to the gait lab for two days. The experiment itself lasts about 1.5 hours per day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
Robert Riener, Prof. Dr principal investigator
Sensory Motor Systems Lab, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANGELAA in people with Gait Disorder, Sensorimotor, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 28 Apr 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of gait pattern using an actuated transfemoral prosthesis compared to a passive prosthesis (time frame: Subjects will come to the gait lab for two days. The experiment itself lasts about 1.5 hours per day.). 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 28 Apr 2015.