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Clinical Trials/NCT04314960
NCT04314960
Unknown
Not Applicable

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

Shmuel Springer1 site in 1 country22 target enrollmentJune 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint Instability
Sponsor
Shmuel Springer
Enrollment
22
Locations
1
Primary Endpoint
Immediate change in ankle inversion angle during heel strike
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2020
End Date
June 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Shmuel Springer

Chair, Physiotherapy Department, Neuromuscular & Human Performance Laboratory

Ariel University

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Immediate change in ankle inversion angle during heel strike

Time Frame: immediately after the intervention

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.

Change in peroneal muscle electromyography at 4 weeks

Time Frame: through intervention completion, approximately 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.

Immediate change in peroneal muscle electromyography

Time Frame: immediately after the intervention

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.

Change in ankle inversion angle during heel strike at 4 weeks

Time Frame: through intervention completion, approximately 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.

Secondary Outcomes

  • Change in Star excursion balance test (SEBT) score(through intervention completion, approximately at 4 weeks)
  • Peroneal reaction time (PRT)(through intervention completion, approximately at 4 weeks)
  • Time to stabilization (TTS)(through intervention completion, approximately at 4 weeks)

Study Sites (1)

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