Functional Electrical Stimulation in Chronic Ankle Instability

NCT04314960 | Unknown FDA Device

• 1 other identifier: AU-HEA-SS-20200308a
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with chronic ankle instability (CAI) display neuromuscular deficits such as altered control of posture and gait when compared with healthy controls. These deficits may be attributed to muscle inhibition occurring after a surrounding joint structure has been damaged. Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may overcome inhibition, and which is coupled with a functional task such as gait. The current study aims to investigate the short and immediate effects of FES on gait parameters and postural control in subjects with CAI. Prior to intervention, treadmill gait will be evaluated using a motion analysis system, and postural control will be evaluated in a series of tests that measure balance, reaction time to ankle perturbation and stabilization ability after jump-landing. Then, a 20 minutes gait training with an FES device will be applied. Immediate effects of the training on gait parameters will be assessed. For medium-term effects evaluation, subjects will return for additional 7 training sessions (2 per week for 4 weeks), following by a complete measurements acquisition as prior to intervention. At six months follow-up, subjects will be contacted for collecting subjective outcomes.

Conditions

Joint Instability; Ankle Sprains; Sport Injury

Keywords

Chronic ankle instability; Rehabilitation; Neuromuscular control; Gait; Electrical stimulation

Outcome Measures

Primary Outcomes (4)

• Immediate change in ankle inversion angle during heel strike

  Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system. Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.

  immediately after the intervention

• Change in ankle inversion angle during heel strike at 4 weeks

  Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system. Change will be measured between pre-intervention and after completing the entire intervention.

  through intervention completion, approximately at 4 weeks

• Immediate change in peroneal muscle electromyography

  Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike. Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.

  immediately after the intervention

• Change in peroneal muscle electromyography at 4 weeks

  Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike. Change will be measured between pre-intervention and after completing the entire intervention.

  through intervention completion, approximately at 4 weeks

Secondary Outcomes (3)

• Change in Star excursion balance test (SEBT) score

  through intervention completion, approximately at 4 weeks

• Time to stabilization (TTS)

  through intervention completion, approximately at 4 weeks

• Peroneal reaction time (PRT)

  through intervention completion, approximately at 4 weeks

Other Outcomes (2)

• Foot and Ankle Ability Measure (FAAM) - questionnaire

  through intervention completion, approximately at 4 weeks

• Cumberland Ankle Instability Tool (CAIT) - questionnaire

  through intervention completion, approximately at 4 weeks

Study Arms (1)

CAI subjects

EXPERIMENTAL

Subjects in this group will receive eight 20-minutes gait training sessions with functional electrical stimulation.

Device: Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)

Interventions

Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA) DEVICE

Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may bypass spinal and supraspinal inhibition, and which is coupled with a functional task such as gait. Gait training will be conducted on a treadmill.

CAI subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A history of at least one significant ankle sprain:
• At least 12 months prior to participating in the study
• Was characterized by inflammatory symptoms (i.e. pain and swelling)
• Caused at least one day of decreased physical activity
• At least 3 months since the last acute ankle sprain that results in inflammatory symptoms and at least one interrupted day of desired physical activity.
• History of the previously injured ankle 'giving way' at least twice during the last 6 months, and/or 'feelings of instability' and/or recurrent sprain.
• Being able to bear full weight on the injured lower extremity with no more than mild discomfort.
• Scoring\<24 in the Cumberland Ankle Instability Tool (CAIT)

You may not qualify if:

• A history of previous surgeries to a musculoskeletal structure in either lower limb.
• A history of a fracture requiring re-alignment
• Any acute injury to a lower limb in the last 3 months.

Sponsors & Collaborators

• Shmuel Springer: lead

Study Sites (1)

Ariel University

Ariel, 40700, Israel

RECRUITING

MeSH Terms

Conditions

Joint Instability; Ankle Injuries

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• Shmuel Springer, PhD

  Ariel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uri Gottlieb, MSc

CONTACT

+972542022767; urigott@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Physiotherapy Department, Neuromuscular & Human Performance Laboratory

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 19, 2020
• Study Start: June 23, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)