An interventional study of Clinical Evaluation and Evaluation of Passive Ankle Stiffness in Diabetic Peripheral Neuropathy, sponsored by Florida Institute for Human and Machine Cognition. Recruiting at 1 site in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Florida Institute for Human and Machine Cognition · Not applicable, Interventional, and Basic science
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Among 3,022 studies in Diabetes Mellitus with a site in United States — 289 open to participants now, 390 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,022 studies in Diabetes Mellitus with a site in United States, this one is the 1,511th largest by planned enrollment of the 2,501 interventional ones that give a count, is one of 88 that started in 2024, is one of 1,417 with no phase, reaches primary completion later than 213 of the 382 other live ones, and was the 2,730th registered.
8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.
Browse Diabetes Mellitus studies →289 of the 3,022 studies in Diabetes Mellitus with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Wayne State University · Sites in United States
Ages 16–20
Mayo Clinic · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 650 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 45 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,022 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 262 · Phase 2 371 · Phase 3 340 · Phase 4 215
First in 1976; this study’s year is marked. 88 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 82 across the 2,501 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 990 (41%) have results posted.
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852 of 3,022 have an industry lead sponsor. The 10 most frequent:
Florida Institute for Human and Machine Cognition is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Florida Institute for Human and Machine Cognition has 2 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Add all 141 to your calendar (.ics) → With an account.
Among the 3,022 studies in Diabetes Mellitus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.
Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals with DM. Consequences of DPN include reduced sensation and feedback from the foot and lower limb and increased plantar pressures, predisposing patients to ulcers and lower extremity amputation. Individuals with DPN experience decreased quality of life compared with their healthy and non-neuropathic DM peers, and report problems with mobility, daily activities, pain, and discomfort. Additionally, people with DPN display reduced functional ambulation, step counts, and walking speed. Though increases in physical activity and functional capacity have been associated with improvements in quality of life, DPN poses a unique challenge in mitigating risk while pursuing traditional exercise and walking programs.
Traditional gait training programs used to improve walking function may increase ulceration risk, making these interventions unsuitable if not tailored for people with DPN. The goal of this study is to elucidate the underlying biomechanical mechanisms contributing to the inter-relationships between plantar pressure and propulsion in individuals with DPN, and to examine the safety and feasibility of using real-time biofeedback to modify plantar pressure and propulsion during gait.
The aims of this study are to evaluate (1) biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN; (2) biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN and age-similar controls; and (3) the acceptability, feasibility, safety, and preliminary effects of gait training in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow for the design of more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics.
Able-bodied participants will complete three experimental sessions and participants with DPN will complete a total of seven experimental sessions. Each session will be approximately 2-3 hours in duration.
Inclusion Criteria for All Participants:
Inclusion Criteria for Participants with DPN:
Exclusion Criteria for Healthy Able-Bodied Individuals:
Exclusion Criteria for All Participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
Other: Clinical Evaluation · Other: Evaluation of Passive Ankle Stiffness · Other: Gait Biomechanics · Other: Gait Biofeedback
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
Other: Clinical Evaluation · Other: Evaluation of Passive Ankle Stiffness · Other: Gait Biomechanics · Other: Gait Biofeedback · Other: Plantar Pressure Biofeedback Gait Training · Other: Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
Other: Clinical Evaluation · Other: Evaluation of Passive Ankle Stiffness · Other: Gait Biomechanics · Other: Gait Biofeedback · Other: Plantar Pressure Biofeedback Gait Training · Other: Propulsion Biofeedback Gait Training
A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function. Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.
Participants will be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. EMG activity will be recorded from lower limb muscles (gastrocnemius, soleus, tibialis anterior) during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness (i.e., active + passive) at a fixed activation. In three additional trials, the dynamometer will move the ankle joint through the same motion without active subject resistance and the same analytical procedures will derive passive ankle joint stiffness.
Three-dimensional gait analysis is performed as participants walk at a self-selected speed on an instrumented treadmill. Reflective markers are attached to lower extremity segments. Elastic bands are wrapped around the thighs, calves, and pelvis to which small, thermoplastic shells containing reflective markers are attached. Additional markers are taped to the participant's shoes and on the upper back, shoulder, hip, knee, and ankle joints with adhesive skin tape. Marker data is collected using a 7-camera motion analysis system (Vicon Inc., USA). Vicon motion analysis cameras will collect the location of the retroreflective markers in Vicon Nexus software.
Audio-visual biofeedback will be provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map will represent the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target will be provided using the heat map colors of red and target line on the bar graph. For propulsion biofeedback, a visual display with a marker will represent the current propulsion (peak AGRF) and a target provided to modulate propulsion. The plantar pressure and AGRF measurements from the participant's baseline walking trials will be used to determine customized biofeedback targets.
Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target.
Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.
Biomechanical plantar pressure
Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Biomechanical Propulsion
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Biomechanical modulation of ankle stiffness
Participants will walk for 3 minutes on a treadmill at their self-selected speed to enable stabilization of movement patterns, warmup, and preconditioning of lower extremity muscles prior to dynamometer tasks. Participants will then be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. Electromyography (EMG) activity will be recorded from lower limb muscles during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness at a fixed activation.
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Changes induced by biofeedback in plantar pressure
Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized. Regression analysis will be used to examine plantar pressure during gait by study group.
Time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Changes induced by biofeedback in propulsion
Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion. Regression analysis will be used to examine propulsion during gait by study group.
Time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Changes induced by biofeedback in biomechanics during gait
Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.
Time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Plan to share: Yes — Individual participant data that underlie published results will be made available for sharing with other researchers after de-identification.
Supporting information: Study protocol
Time frame: Data will be available beginning 12 months and ending 36 months following publication of the the findings from this study.
Access criteria: Data will be available to be shared with scientific and clinical collaborators, clinical and research communities, for individual participant data meta-analyses. Requests should be directed to nrendos@emory.edu and may be submitted up to 36 months following publication of this study. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Aug 2027, 32 months after the start.
Of 1,586 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 32 months is above that.
Counting every sponsor, half of 1,746 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Florida Institute for Human and Machine Cognition