Role of Sensory Deficits on Sensorimotor Control in Athletes With Chronic Ankle Instability

NCT06118879 | Recruiting

• 1 other identifier: NYCU112052AF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Chronic ankle instability (CAI), characterized by instances of repetitive sprains and giving way, is a common chronic dysfunction among athletes. Despite well documented evidence showing impaired peripheral sensory and both central and peripheral motor control, little was known regarding how CAI affects somatosensory cortical activation. Traditionally, management of CAI mostly focused on restoration of motor deficits, with less emphasis on sensory pathway deficits. Only few sensory targeted intervention methods including joint mobilization and massage, have been described. However, methods such as joint mobilization provide not only sensory stimulation but also mechanical alignment correction. In addition, these studies showed functional improvement without exploring mechanisms. Therefore we would like to apply for a three year study grant to firstly investigate the effect of CAI on peripheral and central somatosensation and neuromuscular performance; and secondly to examine the immediate effect of sensory-level electrical stimulation on neurophysiological variables and neuromuscular performance; and lastly to determine the short-term effect of intervention (sensory stimulation with exercise, sham stimulation with exercise, and exercise alone) in athletes with CAI. Research design and methods: This is a cross-sectional exploratory and randomized controlled study. For the first year, we plan to recruit 45 young athletes (20-40 years old) with CAI and 15 matched controls to compare the somatosensory evoked potentials (SEPs), corticomuscular coherence (CMC), α- band event-related desynchronization (ERD), proprioception, two point discrimination threshold of the plantar surfaces, muscle activation and reaching distances of the Y balance test. Activity in the sensorimotor cortex will be recorded using a 64-chanel EEG (SAGA 32/64+ for EEG). Muscle activation is measured using an 8-channel electromyography (EMG) system (Noraxon myo METRICS Portable Lab, Noraxon U.S.A.). For the second year, the 45 young adults with CAI will be randomized into the sensory stimulation (TENS) group, the sham stimulation group, or the control group. The TENS group will receive 40 minutes of sensory electrical stimulation, and the sham group will receive 30 seconds of sensory stimulation at the beginning and end of the treatment. The control group will rest for 40 minutes. The assessment items are identical to those in the first year, and will be carried out before and immediately after the intervention. For the third year, the 45 young adults with CAI will be randomized into the exercise with sensory stimulation (EX-TENS) group, exercise with sham stimulation (EX-ss) group, or exercise alone (EX) group. Participants will receive five sessions of intervention (30 minutes neuromuscular training with or without 40 min stimulation) within two weeks and the assessment will be carried out before and after the intervention. Data analysis: Comparisons of all continuous variables are performed using oneway analysis of variance (ANOVA), and repeated measures ANOVA. The significance level is set at 0.05. Significance. Results of this study provide a better understanding for central somatosensory control mechanisms for chronic ankle instability, and help clinicians and trainers to choose the most appropriate training strategy for people with unstable ankles. We plan to present our work in 3-4 international conferences, and publish 2-3 papers in SCI journals in 5 years.

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

• Cortical activation

  somatosesory evoked potentials and corticomuscular coherence

  5 minutes

Secondary Outcomes (3)

• Proprioception

  10 minutes

• Two-point discrimination

  10 minutes

• Range of motion

  5 minutes

Study Arms (3)

Sensory level stimulation with exercise

EXPERIMENTAL

Device: Transcutaneous electrical stimulation

Sham stimulation with exercise

SHAM COMPARATOR

Device: Transcutaneous electrical stimulation

Exercsie alone

ACTIVE COMPARATOR

Device: Transcutaneous electrical stimulation

Interventions

Transcutaneous electrical stimulation DEVICE

sensory level stimulation, one-leg standing and Y-balance training

Also known as: Neuromuscular training exercise

Exercsie alone; Sensory level stimulation with exercise; Sham stimulation with exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between 18 and 40 years old
• having at least one ankle sprain experience in the past year with sequelae; or having repeated ankle sprain experience in the past year,
• having a "soft foot" sensation within three months
• score ≤ 27 on the Cumberland Ankle Instability Tool (CAIT)

You may not qualify if:

• having a history of lower extremity fracture or surgery, or a history of lower extremity trauma in the past three months
• having experiences of sprained ankles within the previous six weeks
• having pathological joint laxity (positive results on talar tilt test or drawer forward test

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 11221, Taiwan

RECRUITING

Related Publications (10)

• Kim KM, Ingersoll CD, Hertel J. Altered postural modulation of Hoffmann reflex in the soleus and fibularis longus associated with chronic ankle instability. J Electromyogr Kinesiol. 2012 Dec;22(6):997-1002. doi: 10.1016/j.jelekin.2012.06.002. Epub 2012 Jul 13.

  PMID: 22795679 BACKGROUND

• Kim KM, Kim JS, Cruz-Diaz D, Ryu S, Kang M, Taube W. Changes in Spinal and Corticospinal Excitability in Patients with Chronic Ankle Instability: A Systematic Review with Meta-Analysis. J Clin Med. 2019 Jul 16;8(7):1037. doi: 10.3390/jcm8071037.

  PMID: 31315231 BACKGROUND

• Suttmiller AMB, McCann RS. Neural excitability of lower extremity musculature in individuals with and without chronic ankle instability: A systematic review and meta-analysis. J Electromyogr Kinesiol. 2020 Aug;53:102436. doi: 10.1016/j.jelekin.2020.102436. Epub 2020 Jun 1.

  PMID: 32505988 BACKGROUND

• Wikstrom EA, McKeon PO. Predicting balance improvements following STARS treatments in chronic ankle instability participants. J Sci Med Sport. 2017 Apr;20(4):356-361. doi: 10.1016/j.jsams.2016.09.003. Epub 2016 Sep 20.

  PMID: 27840034 BACKGROUND

• Shih YF, Yu HT, Chen WY, Liao KK, Lin HC, Yang YR. The effect of additional joint mobilization on neuromuscular performance in individuals with functional ankle instability. Phys Ther Sport. 2018 Mar;30:22-28. doi: 10.1016/j.ptsp.2017.12.001. Epub 2017 Dec 20.

  PMID: 29310055 BACKGROUND

• McKeon PO, Wikstrom EA. Sensory-Targeted Ankle Rehabilitation Strategies for Chronic Ankle Instability. Med Sci Sports Exerc. 2016 May;48(5):776-84. doi: 10.1249/MSS.0000000000000859.

  PMID: 26717498 BACKGROUND

• Pan LH, Yang WW, Kao CL, Tsai MW, Wei SH, Fregni F, Chen VC, Chou LW. Effects of 8-week sensory electrical stimulation combined with motor training on EEG-EMG coherence and motor function in individuals with stroke. Sci Rep. 2018 Jun 15;8(1):9217. doi: 10.1038/s41598-018-27553-4.

  PMID: 29907780 BACKGROUND

• Kim KM, Croy T, Hertel J, Saliba S. Effects of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction on quadriceps strength, function, and patient-oriented outcomes: a systematic review. J Orthop Sports Phys Ther. 2010 Jul;40(7):383-91. doi: 10.2519/jospt.2010.3184.

  PMID: 20592480 BACKGROUND

• Xue X, Ma T, Li Q, Song Y, Hua Y. Chronic ankle instability is associated with proprioception deficits: A systematic review and meta-analysis. J Sport Health Sci. 2021 Mar;10(2):182-191. doi: 10.1016/j.jshs.2020.09.014. Epub 2020 Oct 2.

  PMID: 33017672 RESULT

• Needle AR, Lepley AS, Grooms DR. Central Nervous System Adaptation After Ligamentous Injury: a Summary of Theories, Evidence, and Clinical Interpretation. Sports Med. 2017 Jul;47(7):1271-1288. doi: 10.1007/s40279-016-0666-y.

  PMID: 28005191 RESULT

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

TW (1)