Functional Electrical Stimulation in Chronic Ankle Instability (ESCAIP)

Shmuel Springer

Status: Unknown

Conditions: Ankle Sprains; Sport Injury; Joint Instability

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04314960

AU-HEA-SS-20200308a

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

CAI subjects

Experimental group

Description:

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

Treatment:

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