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?

The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers.

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.

Is the SMART Rehabilitation for Ankle Injury generally safe for humans?

The research articles reviewed do not provide specific safety data for the SMART Rehabilitation for Ankle Injury or its related interventions. Further studies are needed to establish safety in humans. ^{1 2 3 4 5}

How is the SMART Rehabilitation treatment for ankle injury different from other treatments?

The SMART Rehabilitation treatment is unique because it focuses on sensorimotor training, which aims to improve the brain's ability to control ankle movements, potentially reducing the risk of chronic ankle instability. This approach contrasts with standard care, which may not specifically target the sensorimotor aspects of rehabilitation. ^{6 7 8 9 10}

What data supports the effectiveness of the SMART Rehabilitation treatment for ankle injury?

Research suggests that sensorimotor training, like the SMART treatment, can improve ankle joint function after an ankle sprain by enhancing control and stability. Similar strategies have shown benefits in patients with chronic ankle instability, indicating that targeting sensory input can help improve outcomes. ^{6 11 12 13 14}

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.

Implanted medication pumps, pacemakers or intracardiac lines

History of diagnosed major psychiatric disorder

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

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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 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]

Citations

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sensory-Targeted Ankle Rehabilitation Strategies for Chronic Ankle Instability. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Predicting the success of multimodal rehabilitation in chronic ankle instability based on patient-reported outcomes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted therapy on ankle rehabilitation--a systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Position versus force control: using the 2-DOF robotic ankle trainer to assess ankle's motor control. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A wireless sensory feedback system for real-time gait modification. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Kinetic Gait Analysis Using a Low-Cost Insole. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Monitoring of Patient Mobility for 18 Months Using Inertial Sensors following Traumatic Knee Injury: A Case Study. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Orthopedic rehabilitation using the "Rutgers ankle" interface. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Reviewing effectiveness of ankle assessment techniques for use in robot-assisted therapy. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of foot and ankle injuries. [2005]

13. England pubmed.ncbi.nlm.nih.gov

Robot-assisted ankle rehabilitation: a review. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Towards Optimal Platform-Based Robot Design for Ankle Rehabilitation: The State of the Art and Future Prospects. [2019]