Accidental FallsPhase 2NCT02819011
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
A Phase 2 study testing MBB AFO in people with Accidental Falls and Fall Due to Loss of Equilibrium, run by Bijan Najafi, PhD at 1 site in United States.
Trial summary
The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Fall Due to Loss of Equilibrium, High Risk of Falls Due to Mobility Limitation
- What is being tested?
- MBB AFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 4 Apr 2019
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or older
- High concerns or high risk of fall
- Ambulatory
Who cannot join
- Presence of an active wound infection on either of the foot and ankle
- Use of medication or a medical condition that may have unstable (fluctuate over time) or temporary (less than one month) impact on gait and balance
- Acute fractures on the foot
- Participant of an interventional study within the last 30 days
- Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m (~six feet) without assistance
- Major foot amputation
- Unable or unwilling to participate in all procedures
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults.
Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events
Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage
- Conditions
- Accidental Falls, Fall Due to Loss of Equilibrium, High Risk of Falls Due to Mobility Limitation, Diabetes, Arthritis, Cancer
- Being tested
- MBB AFO, Control
- Keywords
- Ankle Foot Orthoses, falls, Fall Prevention, Frailty, Concern for falls, Footwear, Mobility
- Medical subject headings
- Diabetes Mellitus, Arthritis, Neoplasms, Peripheral Arterial Disease, Parkinson Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBB AFODevice
Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO
ControlOther
Subjects will be provided with a pair of New Balance 813 shoes
| Study group | Role | What they receive |
|---|---|---|
| MBB AFO Group | Experimental | This group will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO for the duration of the study. Receives: Device: MBB AFO |
| No MBB AFO Group | Active comparator | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Sway Change From Baseline to 6 Months
Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Measured: baseline to 6 months
Ankle Sway Change From Baseline to 6 Months
Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Measured: baseline to 6 months
Center of Mass (COM) Sway Change Baseline to 6 Months
Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Measured: baseline to 6 months
Secondary outcomes (9)
Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))
The adherence of participants to the prescribed Ankle-Foot Orthosis (AFO) plus walking shoes was quantified using the response to a self-reported question ("How many hours per day did you wear the prescribed footwear?").
Measured: 6 months
Fall Incidents
Fall incidents during the study
Measured: Baseline, 12 months
Concern for Falling Change Form Baseline to 6 Months
Concern for falling is quantified by Falls Efficacy Scale - International (FES-I) questionnaire. Scores range from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). Higher score indicate worse performance.
Measured: Baseline, 6 months
Physical Activity Level
Physical activity level for 24 hours while wearing their own shoes compared to the walking shoes and compared to walking shoes plus Ankle-Foot Orthosis (AFO). To quantify physical activity, number of taken steps per day was monitored using a pendant wearable sensor called, PAMSys (Biosensics, MA, USA).
Measured: baseline to 6 months
Number of Participants With Adverse Events
Number of participants with adverse events reported during the study. Adverse events was inquired at 1 months, 3 months, 6 months, 12 months after the baseline, and summed at 12 months. If the participant has at least one adverse event reported in any assessed time frame, the participant will be categorized as the participant with adverse event.
Measured: assessed at 1, 3, 6, and 12 months, month 12 reported
Percentage of Participants Who Found the Device Useful and Easy to Use
The participants perceived usefulness of ease of use of wearing Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) based on questionnaires of A technology acceptance model (TAM). Perceived usefulness was assessed using two questions (i.e., "I feel more stable when standing," and "I feel more stable when walking"). Perceived ease of use was assessed using two questions (i.e., "Was easy to take on and off," and "Was comfortable to wear"). The Likert scale (6-point scale from 0-5) was used to quantify how much they disagreed with each statement, including "strongly disagree," "disagree," "somewhat disagree," "somewhat agree," "agree," and "strongly agree," respectively. In this paper, responses were only categorized as positive (3-5 points) or negative (0-2 points) attitudes towards the use of AFO plus walking shoes.
Measured: 6 months
Stride Velocity
stride velocity measured in single-task walking with normal speed
Measured: baseline, 6 months
Stride Time
stride time measured in single task walking with normal speed
Measured: baseline, 6 months
Stride Length
stride length measured in single-task walking with normal speed
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2018
- Study completion4 Apr 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bijan Najafi, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Orthotic Holdings, Inc.
- Responsible party
- Sponsor-investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819011
- Sponsor's protocol ID
- H-38050
- Status last verified
- Feb 2020
- First submitted
- 28 Jun 2016
- Last updated
- 27 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
Publications
Wang C, Goel R, Rahemi H, Zhang Q, Lepow B, Najafi B. Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial. Gerontology. 2019;65(3):299-307. doi: 10.1159/000494114. Epub 2018 Nov 30.
PubMed 30504728Wang C, Goel R, Zhang Q, Lepow B, Najafi B. Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1656-1661. doi: 10.1111/jgs.15929. Epub 2019 Apr 24.
PubMed 31018018
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
- ClinicalTrials.gov ID
- NCT02819011
- Acronym / sponsor ID
- H-38050
- Conditions
- Accidental Falls, Fall Due to Loss of Equilibrium, High Risk of Falls Due to Mobility Limitation, Diabetes, Arthritis, Cancer
- Keywords
- Ankle Foot Orthoses, falls, Fall Prevention, Frailty, Concern for falls, Footwear, Mobility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bijan Najafi, PhDUniversity, hospital or other
- Collaborators
- Orthotic Holdings, Inc.
- Study start
- May 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults.
Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events
Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBB AFO Group | Experimental | Device: MBB AFOThis group will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO for the duration of the study. |
| No MBB AFO Group | Active comparator | Other: ControlThis group will be provided with a pair of New Balance 813 shoes for the duration of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 or older
- High concerns or high risk of fall
- Ambulatory
Key exclusion criteria (7 listed)
- Presence of an active wound infection on either of the foot and ankle
- Use of medication or a medical condition that may have unstable (fluctuate over time) or temporary (less than one month) impact on gait and balance
- Acute fractures on the foot
- Participant of an interventional study within the last 30 days
- Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m (~six feet) without assistance
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 |
|---|---|---|
| MBB AFOSubjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO | Device | MBB AFO Group |
| ControlSubjects will be provided with a pair of New Balance 813 shoes | Other | No MBB AFO Group |
Primary outcome
Hip Sway Change From Baseline to 6 Months
Time frame: baseline to 6 months
Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Ankle Sway Change From Baseline to 6 Months
Time frame: baseline to 6 months
Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Center of Mass (COM) Sway Change Baseline to 6 Months
Time frame: baseline to 6 months
Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
9 secondary outcomes
Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))
Time frame: 6 months
Fall Incidents
Time frame: Baseline, 12 months
Concern for Falling Change Form Baseline to 6 Months
Time frame: Baseline, 6 months
Physical Activity Level
Time frame: baseline to 6 months
Number of Participants With Adverse Events
Time frame: assessed at 1, 3, 6, and 12 months, month 12 reported
Percentage of Participants Who Found the Device Useful and Easy to Use
Time frame: 6 months
Stride Velocity
Time frame: baseline, 6 months
Stride Time
Time frame: baseline, 6 months
Stride Length
Time frame: baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30504728Wang C, Goel R, Rahemi H, Zhang Q, Lepow B, Najafi B. Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial. Gerontology. 2019;65(3):299-307. doi: 10.1159/000494114. Epub 2018 Nov 30.
- Results publication: PubMed 31018018Wang C, Goel R, Zhang Q, Lepow B, Najafi B. Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1656-1661. doi: 10.1111/jgs.15929. Epub 2019 Apr 24.
- Individual participant dataSharing planned: Undecided. Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
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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 MBB AFO in people with Accidental Falls and Fall Due to Loss of Equilibrium, run by Bijan Najafi, PhD 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 3 inclusion and 7 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 27 Feb 2020. 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.
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?
Yes. Results are posted in the registry (first posted 27 Feb 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?
Hip Sway Change From Baseline to 6 Months (time frame: baseline to 6 months). 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?
On the ClinicalTrials.gov record for NCT02819011, which also lists 2 linked publications.
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 Feb 2020.