Walking Aided by a Leg Brace in Stroke SubjectsNCT02122783
Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients
A study testing ADR™ brace resistance and Conventional brace resistance (using hard stops) in people with Walking Aided by a Leg Brace in Stroke Subjects, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Walking Aided by a Leg Brace in Stroke Subjects
- What is being tested?
- ADR™ brace resistance and Conventional brace resistance (using hard stops)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 21 and 70 males and non-pregnant females
- Diagnosis of stroke more than 1 year ago
- Ambulatory at 0.5m/s or greater
- Require unilateral AFOs to ambulate
- Stable medical condition - no concomitant progressive diseases that could affect motor function
- Ability to comply with directions and cooperate with research team
Who cannot join
- Subjects who are currently receiving physical therapy for gait problems
- Anticipated surgical or pharmacologic intervention for tone/contractures during the study period
- Additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures)
- Recent cardiac or active pulmonary disease, liable blood pressure
- Recent back surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients
The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.
Read the detailed description
The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. Participants undergo testing in the gaitlab after using the new brace for a period of time. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.
- Being tested
- ADR™ brace resistance, Conventional brace resistance (using hard stops)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADR™ brace resistanceDevice
Conventional brace resistance (using hard stops)Device
Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs
| Study group | Role | What they receive |
|---|---|---|
| Conventional then Experimental brace resistance | Experimental | Participants received the Default intervention for a period of a month, were evaluated in the lab and then the novel intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention. Receives: Device: ADR™ brace resistance; Device: Conventional brace resistance (using hard stops) |
| Experimental then Conventional brace resistance | Experimental | Participants received the the novel elastomer to provide brace support intervention for a period of a month, were evaluated in the lab and then the conventional intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention. Receives: Device: ADR™ brace resistance; Device: Conventional brace resistance (using hard stops) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-selected Walking Velocity
walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
Measured: 8 weeks
Step Length Symmetry
step length symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step length on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, meters to meters).
Measured: 8 weeks
Step Time Symmetry
step time symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step time on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, seconds to seconds).
Measured: 8 weeks
Secondary outcomes (4)
Joint Kinematics
joint kinematics will be assessed using motion capture system
Measured: 8 weeks
Joint Kinetics
joint kinematics will be assessed using motion capture and biomechanical force measurement systems
Measured: 8 weeks
Activity (Step Count)
activity will be measured using accelerometer based step activity monitoring devices
Measured: 8 weeks
Subject Opinions
subject opinions will be measured using surveys and questionnaires
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Walking Aided by a Leg Brace in Stroke SubjectsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukul Talaty, Albert Einstein Healthcare Network
- Investigators
- Mukul Talaty, PhD, Principal investigator, Albert Einstein (MossRehab)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122783
- Sponsor's protocol ID
- HN 4422
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2014
- Last updated
- 4 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients
- ClinicalTrials.gov ID
- NCT02122783
- Acronym / sponsor ID
- HN 4422
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 1 May 2020
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 evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.
Detailed description
The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. Participants undergo testing in the gaitlab after using the new brace for a period of time. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional then Experimental brace resistance | Experimental | Device: ADR™ brace resistance, Device: Conventional brace resistance (using hard stops)Participants received the Default intervention for a period of a month, were evaluated in the lab and then the novel intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention. |
| Experimental then Conventional brace resistance | Experimental | Device: ADR™ brace resistance, Device: Conventional brace resistance (using hard stops)Participants received the the novel elastomer to provide brace support intervention for a period of a month, were evaluated in the lab and then the conventional intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 21 and 70 males and non-pregnant females
- Diagnosis of stroke more than 1 year ago
- Ambulatory at 0.5m/s or greater
- Require unilateral AFOs to ambulate
- Stable medical condition - no concomitant progressive diseases that could affect motor function
Key exclusion criteria (5 listed)
- Subjects who are currently receiving physical therapy for gait problems
- Anticipated surgical or pharmacologic intervention for tone/contractures during the study period
- Additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures)
- Recent cardiac or active pulmonary disease, liable blood pressure
- Recent back surgery
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 |
|---|---|---|
| ADR™ brace resistance | Device | Conventional then Experimental brace resistance, Experimental then Conventional brace resistance |
| Conventional brace resistance (using hard stops)Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs | Device | Conventional then Experimental brace resistance, Experimental then Conventional brace resistance |
Primary outcome
Self-selected Walking Velocity
Time frame: 8 weeks
walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
Step Length Symmetry
Time frame: 8 weeks
step length symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step length on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, meters to meters).
Step Time Symmetry
Time frame: 8 weeks
step time symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step time on more involved or affected side compared to the less involved or affected (i.e. the "normal") side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, seconds to seconds).
4 secondary outcomes
Joint Kinematics
Time frame: 8 weeks
Joint Kinetics
Time frame: 8 weeks
Activity (Step Count)
Time frame: 8 weeks
Subject Opinions
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mukul Talaty, PhD principal investigator
Albert Einstein (MossRehab)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADR™ brace resistance and Conventional brace resistance (using hard stops) in people with Walking Aided by a Leg Brace in Stroke Subjects, run by Albert Einstein Healthcare Network at 1 site in United States.
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 6 inclusion and 5 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 4 Oct 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-selected Walking Velocity (time frame: 8 weeks). 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 4 Oct 2021.