Functional Electrical Stimulation in Chronic Ankle Instability (ESCAIP)

Immediate and Long-term Effects of Gait Training With Functional Electrical Stimulation in Subjects With Chronic Ankle Instability

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.

Study Overview

• Status: Unknown
• Conditions: Joint Instability; Sport Injury; Ankle Sprains
• Intervention / Treatment: Device: Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ariel, Israel, 40700
    • Recruiting
    • Ariel University
    • Contact: Uri Gottlieb; Phone Number: 0542022767; Email: urigott@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A history of at least one significant ankle sprain:

   1. At least 12 months prior to participating in the study
   2. Was characterized by inflammatory symptoms (i.e. pain and swelling)
   3. Caused at least one day of decreased physical activity
2. 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.
3. 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.
4. Being able to bear full weight on the injured lower extremity with no more than mild discomfort.
5. Scoring<24 in the Cumberland Ankle Instability Tool (CAIT)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAI subjects; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Star excursion balance test (SEBT) score	The SEBT has been previously described as a postural control test that can differ between subjects with CAI and healthy controls. The test is performed with the subjects standing barefoot in the middle of a grid formed by eight tape measures extending out at 45° from each other. While the subject is balancing on one leg that is placed in the middle of the grid, the other leg has to reach as far as possible in each direction. The reached distance in centimeters is recorded, with the greater distance representing better postural stability. An average scores is calculated and normalized to the length of the subject's leg in centimeters.	through intervention completion, approximately at 4 weeks
Time to stabilization (TTS)	TTS is the time required to normalize ground reaction forces (GRF) after following a jump-landing. To measure TTS, subjects will be required to perform a single-leg drop-jump from a 40-cm box onto a force plate (Kistler, Switzerland) and keep balancing on a single leg for 20 seconds. GRF recordings will be analyzed to determine TTS in seconds in the ML and AP planes, as was previously described. Shorter duration demonstrates better postural stability. Subjects will be allowed at least 3 practice trials, following by 5 successful jumps landings. A rest period of 30 seconds will be allowed between jumps. If a subject will not be able to stabilize for at least 20 seconds, the trial will be repeated. Lower values indicate better postural control.	through intervention completion, approximately at 4 weeks
Peroneal reaction time (PRT)	PRT is the time duration between and ankle inversion perturbation and beginning of peroneal muscle activation which is recognized using EMG. Subjects will stand on an inversion stimulator. In an unknown time, a sudden inversion perturbation will occur. Time measurement between perturbation time and muscle activation time is measured in seconds. Lower values indicate better postural control.	through intervention completion, approximately at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot and Ankle Ability Measure (FAAM) - questionnaire	A self-reported functional outcome measure utilized to track subjective changes in perceived pain and ankle function Score ranges between 0-100. Higher scores represent higher levels of function, with score of 100 represents no disability.	through intervention completion, approximately at 4 weeks
Cumberland Ankle Instability Tool (CAIT) - questionnaire	A self-reported outcome measure designated for people with chronic ankle instability. Will also serve as an inclusion criteria. Score ranges between 0-30, with lower scores indicate less ankle instability.	through intervention completion, approximately at 4 weeks

Collaborators and Investigators

• Sponsor: Shmuel Springer
• Investigators: Principal Investigator: Shmuel Springer, PhD, Ariel University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait; Electrical stimulation; Chronic ankle instability; Neuromuscular control
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Ankle Injuries; Joint Instability; Athletic Injuries
• Other Study ID Numbers: AU-HEA-SS-20200308a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not decided yet, but optional to share all data after concealing subject's identifying details.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes