Limb SalvageNCT03107728
The IM ABLE Study: A Study of Warriors & Veterans Following Neuromusculoskeletal Injury of the Lower Limb
A study testing Advanced orthotic brace and Conventional orthotic brace in people with Limb Salvage and Braces, run by University of South Florida at 2 sites in United States.
Trial summary
The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Limb Salvage, Braces, Lower Extremity
- What is being tested?
- Advanced orthotic brace and Conventional orthotic brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2018to Sep 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower extremity injury of any etiology requiring use of an AFO
- Male or Female, of any ethnicity
- 18-65 yrs of age
- 100-275 lbs
- ≥ 1 yr. of orthotic experience
Who cannot join
- Body weight <100 or >275 lbs
- Does not speak English or Spanish
- Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Hanger, Inc
Houston, Texas, 77025
Shane Wurdeman, PhD, 402-290-8051, swurdeman@hanger.com
- Recruiting
New York VA
New York, New York, 10010
Jason Maikos, PhD, 212-686-7500 ext. 7482, jason.maikos@va.gov
About this study
Official title: The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb
The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.
Read the detailed description
There were approximately 20,000 extremity trauma cases associated with the wars in Iraq and Afghanistan. Many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. Many continue functioning with use of their orthosis while others may seek delayed amputation. It is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(LE) trauma. The IDEO (Intrepid Dynamic Exoskeletal Orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (HELET) and limb salvage surgeries primarily effecting the LE below the level of the knee joint. The IDEO represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. Problematically, few studies have reported outcomes associated with these devices. In the few studies available, sample sizes are small which greatly reduces generalizability of study findings. The purpose of the IM ABLE study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.
- Conditions
- Limb Salvage, Braces, Lower Extremity
- Being tested
- Advanced orthotic brace, Conventional orthotic brace
- Keywords
- orthotics, high-energy lower extremity trauma, physical therapy, bracing, functional performance, performance assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced orthotic braceDevice
Participants will use an advanced exoskeletal orthosis.
Conventional orthotic braceDevice
Participants will use the standard of care orthosis
| Study group | Role | What they receive |
|---|---|---|
| Advanced orthotic brace | Experimental | Not described Receives: Device: Advanced orthotic brace |
| Conventional orthotic brace | Active comparator | Not described Receives: Device: Conventional orthotic brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mobility
Mobility will be assessed with the Timed Up \& Go test. subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Patients are usually permitted to use a walking aid, but not to use physical assistance.
Measured: Mobility will be assessed at Week 2 and Week 4
Change in Ambulatory Function
The 2 Minute Walk Test will be used to assess ambulatory function
Measured: Ambulatory Function will be assessed at week 2 and week 4.
Secondary outcomes (3)
Perceived Function
Perceived Function will be assessed via the EQ-5D (EuroQol 5D), a five item ordinally scaled patient self-report.
Measured: At week 2 and week 4
Pain
Pain rating scale 0-10
Measured: At week 2 and week 4
Safety will be measured with the Activities Balance Confidence Scale
Safety will be measured with the Activities Balance Confidence Scale, a 16 item self-report measure of perceived balance confidence
Measured: At week 2 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start22 Feb 2018
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb SalvageStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, Hanger Clinic: Prosthetics & Orthotics
- Responsible party
- Principal investigator, Jason Highsmith, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107728
- Sponsor's protocol ID
- Pro00026645
- Other IDs
- W81XWH-16-1-0738
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb
- ClinicalTrials.gov ID
- NCT03107728
- Acronym / sponsor ID
- Pro00026645
- Conditions
- Limb Salvage, Braces, Lower Extremity
- Keywords
- orthotics, high-energy lower extremity trauma, physical therapy, bracing, functional performance, performance assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, Hanger Clinic: Prosthetics & Orthotics
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Apr 2017 (actual)
- 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 the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.
Detailed description
There were approximately 20,000 extremity trauma cases associated with the wars in Iraq and Afghanistan. Many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. Many continue functioning with use of their orthosis while others may seek delayed amputation. It is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(LE) trauma. The IDEO (Intrepid Dynamic Exoskeletal Orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (HELET) and limb salvage surgeries primarily effecting the LE below the level of the knee joint. The IDEO represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. Problematically, few studies have reported outcomes associated with these devices. In the few studies available, sample sizes are small which greatly reduces generalizability of study findings. The purpose of the IM ABLE study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced orthotic brace | Experimental | Device: Advanced orthotic brace |
| Conventional orthotic brace | Active comparator | Device: Conventional orthotic brace |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Lower extremity injury of any etiology requiring use of an AFO
- Male or Female, of any ethnicity
- 18-65 yrs of age
- 100-275 lbs
- ≥ 1 yr. of orthotic experience
Key exclusion criteria (3 listed)
- Body weight <100 or >275 lbs
- Does not speak English or Spanish
- Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)
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 |
|---|---|---|
| Advanced orthotic braceParticipants will use an advanced exoskeletal orthosis. | Device | Advanced orthotic brace |
| Conventional orthotic braceParticipants will use the standard of care orthosis | Device | Conventional orthotic brace |
Primary outcome
Change in Mobility
Time frame: Mobility will be assessed at Week 2 and Week 4
Mobility will be assessed with the Timed Up \& Go test. subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Patients are usually permitted to use a walking aid, but not to use physical assistance.
Change in Ambulatory Function
Time frame: Ambulatory Function will be assessed at week 2 and week 4.
The 2 Minute Walk Test will be used to assess ambulatory function
3 secondary outcomes
Perceived Function
Time frame: At week 2 and week 4
Pain
Time frame: At week 2 and week 4
Safety will be measured with the Activities Balance Confidence Scale
Time frame: At week 2 and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced orthotic brace and Conventional orthotic brace in people with Limb Salvage and Braces, run by University of South Florida at 2 sites 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 5 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mobility (time frame: Mobility will be assessed at Week 2 and Week 4). The study lists 2 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 20 Mar 2019; AzTrials last refreshed its copy on 2 Nov 2026.