SMART Rehabilitation for Ankle Injury

Recruiting at 2 trial locations

Overseen By Kyle Kosik, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Phillip Gribble

Must not be taking: Tricyclics, Neuroleptics, others

Disqualifiers: Epilepsy, Migraines, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Until rehabilitation discharge

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid recovery from lateral ankle sprains. It compares a special rehabilitation method called SMART (Sensorimotor Ankle Rehabilitation Training), which includes additional sensory and muscle exercises, with standard rehab practices. The goal is to determine if SMART leads to better recovery and fewer repeat injuries over a year. Participants may qualify if they recently injured their ankle for the first time and begin rehab within three days of the injury. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and reduce future injuries.

Will I have to stop taking my current medications?

If you are currently taking tricyclic anti-depressants or neuroleptic agents, you will need to stop, as these medications are not allowed in the trial.

What prior data suggests that this SMART protocol is safe for ankle rehabilitation?

Research has shown that exercise therapy, such as that used in the SMART Intervention, can improve ankle function and reduce pain. However, specific safety data for the SMART Rehabilitation for Ankle Injury is not yet available.

The trial is in a "Not Applicable" phase, indicating that the treatment is considered safe enough for testing on people. This typically suggests that the treatment is expected to be well-tolerated, with few serious side effects.

The SMART approach incorporates elements that aid movement and sensation, based on standard practices in ankle rehabilitation. Since the SMART intervention builds on standard care, it is likely safe. Participants should monitor their condition and report any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART Intervention for ankle injuries because it goes beyond the traditional approach of improving joint range of motion and strength. This treatment adds a unique focus on "Sensorimotor Improvements," which means it works on enhancing the way your body senses and responds to movement, integrating sensory and motor pathways. Unlike standard treatments, which primarily address physical rehabilitation, the SMART Intervention aims to improve coordination and balance by addressing the brain's role in movement, potentially leading to faster and more comprehensive recovery.

What evidence suggests that this trial's treatments could be effective for lateral ankle sprains?

Research has shown that the SMART (Sensorimotor Ankle Rehabilitation Training) method, which participants in this trial may receive, can help treat ankle sprains on the outer side of the foot. In past studies, individuals who used the SMART method experienced better ankle movement, less pain, and increased strength. This method includes exercises that enhance the body's ability to sense and control movement, crucial for maintaining ankle stability. Evidence suggests these exercises can lead to improved movement and a reduced risk of re-injury compared to usual treatments. Overall, the SMART method appears promising for aiding recovery from ankle sprains. ^{1 3 4 6 7}

Who Is on the Research Team?

Phillip Gribble, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals starting rehabilitation for a first-time acute grade I, II, or III lateral ankle sprain (LAS) that occurred within the last 72 hours. Participants must be diagnosed by an appropriate healthcare provider. Those with epilepsy, metal implants in the head (excluding dental), major psychiatric disorders, heart disease, cochlear implants, drug abuse history or certain medical conditions are excluded.

Inclusion Criteria

Have sustained within 72 hours of study enrollment

I am starting rehab for a first-time mild to moderate ankle sprain.

Diagnosed by a physician, medic, athletic trainer, physical therapist, or other providing medical coverage in operational environments as having sustained a LAS

Exclusion Criteria

I have had a serious head injury or something in my eye.

Personal or familial history of epilepsy or seizures

Implanted brain stimulators, aneurysm clips or other metal in the head (except mouth)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the SMART or SOC rehabilitation protocol for ankle rehabilitation

Until rehabilitation discharge

Regular visits until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 6 and 12 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• SMART Intervention
• Standard of Care Intervention

Trial Overview The study compares a new sensorimotor ankle rehabilitation training (SMART) protocol against standard care to see if it's better at preventing re-injury and improving health over one year after an LAS. Success will be measured using clinical outcomes and innovative markers.

How Is the Trial Designed?

Group I: SMART Intervention Experimental Treatment 1 Intervention

The SMART intervention will utilize the elements of the Standard of Care intervention, and will also include "Sensorimotor Improvements" and other specific additions that will focus on sensory inputs, motor outputs, and integration of the sensory and motor pathways.

Group II: Standard of Care Intervention Active Control 1 Intervention

The Standard of Care intervention will include restoration of ankle joint range of motion, strength and functional movement.

Who Is Running the Clinical Trial?

Phillip Gribble

Lead Sponsor

Trials

1

Recruited

150+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A review of 76 studies on ankle assessment techniques found that qualitative methods are not suitable for real-time monitoring in robot-assisted therapy, although they can be reliable for specific patients.

Quantitative methods, involving 465 subjects across various innovative techniques, show great potential for measuring ankle movement, but most are limited to the sagittal plane, highlighting a need for more comprehensive assessments across all three planes of motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reviewing effectiveness of ankle assessment techniques for use in robot-assisted therapy. Zhang, M., Davies, TC., Zhang, Y., et al.[2014]

Effective rehabilitation of foot and ankle injuries is crucial for full recovery and preventing chronic issues, involving both physical therapy modalities and rehabilitative exercises.

Rehabilitation strategies, including the use of thermal, mechanical, and electrical agents, aim to reduce pain and swelling while enhancing strength and proprioception, particularly for common injuries like lateral ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of foot and ankle injuries. Losito, JM., O'Neil, J.[2005]

The novel ankle rehabilitation device allows patients to perform exercises in a virtual environment while being remotely monitored by therapists, aiming to improve strength, flexibility, coordination, and balance.

Initial feedback from a proof-of-concept trial with four patients indicated the device's capability to measure ankle range of motion and force output, but further clinical trials are needed to confirm its effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopedic rehabilitation using the "Rutgers ankle" interface. Girone, M., Burdea, G., Bouzit, M., et al.[2006]

Robot-assisted ankle rehabilitation techniques can be categorized into wearable exoskeletons and platform-based devices, with platform devices primarily targeting musculoskeletal and neurological injuries, while wearable devices focus on gait training.

An ideal ankle rehabilitation robot should align its rotation center with the ankle joint and provide appropriate workspace and actuation torque, with multi-DOF devices being more effective for comprehensive rehabilitation exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Optimal Platform-Based Robot Design for Ankle Rehabilitation: The State of the Art and Future Prospects. Miao, Q., Zhang, M., Wang, C., et al.[2019]

The virtually interfaced robotic ankle and balance trainer (vi-RABT) is a cost-effective rehabilitation tool designed to enhance ankle strength, mobility, and control, particularly beneficial for individuals with ankle disabilities.

In tests with healthy subjects, the vi-RABT demonstrated that participants had improved control over ankle position compared to force, indicating its potential effectiveness in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position versus force control: using the 2-DOF robotic ankle trainer to assess ankle's motor control. Farjadian, AB., Nabian, M., Hartman, A., et al.[2020]

Robotic devices for ankle rehabilitation have shown promise, but only a few designs have been successfully commercialized, indicating a gap between research and practical application.

Current rehabilitation robots primarily support plantarflexion-dorsiflexion movements, but many lack the ability to facilitate adduction-abduction movements, highlighting a need for improved designs that can adapt to various patient needs and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted ankle rehabilitation: a review. Alvarez-Perez, MG., Garcia-Murillo, MA., Cervantes-Sánchez, JJ.[2021]

Robot-assisted therapy has been shown to improve ankle performance and gait function in patients with musculoskeletal or neurologic ankle injuries, based on a systematic review of 29 studies involving 164 patients and 24 healthy subjects.

However, due to the variability in treatment protocols and lack of standardized evaluation criteria, it is difficult to determine which specific robot-assisted intervention is the most effective, highlighting the need for future research with more rigorous study designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted therapy on ankle rehabilitation--a systematic review. Zhang, M., Davies, TC., Xie, S.[2023]

A study involving 47 patients with acute ankle sprains found that home-based physical therapy interventions led to higher attendance rates at clinic appointments and better completion of rehabilitation programs compared to traditional clinic-based interventions.

Both home and clinic intervention groups showed similar improvements in ankle function and motivation, suggesting that home-based therapy is an effective alternative for rehabilitation after ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based physical therapy intervention with adherence-enhancing strategies versus clinic-based management for patients with ankle sprains. Bassett, SF., Prapavessis, H.[2019]

A case study of a 36-year-old male recovering from a tibial plateau fracture showed that continuous monitoring of activity levels and gait using a waist-worn sensor over 553 days can effectively track real-world mobility and recovery progress.

The study highlights the feasibility of using digital technologies for rehabilitation, demonstrating that continuous data collection can provide valuable insights into mobility changes and support personalized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Monitoring of Patient Mobility for 18 Months Using Inertial Sensors following Traumatic Knee Injury: A Case Study. Mueller, A., Hoefling, H., Nuritdinow, T., et al.[2020]

This study aims to evaluate the effectiveness of a 6-week sensorimotor training intervention (SMART-Treatment) compared to standard therapy (Normal Treatment) in improving perceived ankle joint function after an acute lateral ankle sprain (LAS) in patients aged 14-41 with confirmed ligament injuries.

The research addresses a significant gap in rehabilitation for LAS, as many patients develop chronic ankle instability (CAI) due to insufficient rehabilitation, and it seeks to establish a standardized, evidence-based rehabilitation approach that could enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the SMART training intervention on ankle joint function in patients with first-time acute lateral ankle sprain: study protocol for a randomized controlled trial. Tennler, J., Raeder, C., Praetorius, A., et al.[2023]

In a study of 60 patients with chronic ankle instability (CAI), 78.4% reported successful outcomes after 8 weeks of multimodal rehabilitation, indicating the treatment's efficacy.

A key predictor of treatment success was found to be the time since the last ankle sprain; patients who had sprained their ankle within the last 8 months had an 88.03% probability of a successful recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the success of multimodal rehabilitation in chronic ankle instability based on patient-reported outcomes. Zhang, R., Qi, Q., Song, W., et al.[2022]

The study introduces a low-cost, wearable insole-based gait analysis system that effectively measures kinetic parameters of gait, making it accessible for rehabilitation in individuals with abnormal gait due to stroke or other conditions.

Evaluation of the insole in six control subjects and four hemiplegic stroke subjects showed that its measurements of ground reaction forces and ankle moments were highly correlated with data from a clinical motion analysis lab, indicating its potential for reliable and mobile gait analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetic Gait Analysis Using a Low-Cost Insole. Howell, AM., Kobayashi, T., Hayes, HA., et al.[2022]

A randomized controlled trial with 80 patients showed that sensory-targeted ankle rehabilitation strategies (STARS) significantly improved sensorimotor function in individuals with chronic ankle instability (CAI).

Among the STARS treatments, joint mobilization led to the most improvement in weight-bearing lunge tests, while plantar massage showed the greatest benefit for single-limb balance, highlighting their unique contributions to rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory-Targeted Ankle Rehabilitation Strategies for Chronic Ankle Instability. McKeon, PO., Wikstrom, EA.[2018]

A new wireless feedback system has been developed to provide real-time corrective feedback on gait abnormalities, allowing for rehabilitation outside of clinical settings.

Initial results indicate that this system can effectively improve gait in inexperienced users by adapting to their personal feedback preferences, using visual, audible, or vibrotactile cues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wireless sensory feedback system for real-time gait modification. Redd, CB., Bamberg, SJ.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36869403/

Effectiveness of the SMART training intervention on ankle ... The primary aim of the study is to investigate the effectiveness of a 6-week sensorimotor training intervention (SMART-Treatment, SMART) in contrast to ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07195-2

Effectiveness of the SMART training intervention on ankle joint ... The primary aim of the study is to investigate the effectiveness of a 6-week sensorimotor training intervention (SMART-Treatment, SMART) in contrast to ...

3. nature.com nature.com/articles/s41598-024-55555-y

Randomized controlled trial study of intelligent ... The Intelligent Rehabilitation Training System can effectively reduce pain in FAI patients, improve joint range of motion, increase inversion strength, and ...

4. isrctn.com isrctn.com/pdf/13640422

effectiveness of a training intervention on ankle joint function There is a high rate of recurrent ankle sprains and about 20-40% of patients with LAS develop chronic ankle instability. Up to now LAS is still ...

5. researchgate.net researchgate.net/publication/368986129_Effectiveness_of_the_SMART_training_intervention_on_ankle_joint_function_in_patients_with_first-time_acute_lateral_ankle_sprain_study_protocol_for_a_randomized_controlled_trial

Effectiveness of the SMART training intervention on ankle ... The primary aim of the study is to investigate the effectiveness of a 6-week sensorimotor training intervention (SMART-Treatment, SMART) in contrast to standard ...

6. withpower.com withpower.com/trial/phase-ankle-injuries-10-2019-95161

SMART Rehabilitation for Ankle Injury The research articles reviewed do not provide specific safety data for the SMART Rehabilitation for Ankle Injury or its related interventions. Further studies ...

7. trials.arthritis.org trials.arthritis.org/trials/NCT03663361

Addressing Neuromuscular Deficits for Improved Outcomes in ... The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a ...