Functional Electrical Stimulation in Chronic Ankle Instability (ESCAIP)
Primary Purpose
Joint Instability, Ankle Sprains, Sport Injury
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)
Sponsored by
About this trial
This is an interventional treatment trial for Joint Instability focused on measuring Chronic ankle instability, Rehabilitation, Neuromuscular control, Gait, Electrical stimulation
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.
Sites / Locations
- Ariel UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAI subjects
Arm Description
Subjects in this group will receive eight 20-minutes gait training sessions with functional electrical stimulation.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04314960
Brief Title
Functional Electrical Stimulation in Chronic Ankle Instability
Acronym
ESCAIP
Official Title
Immediate and Long-term Effects of Gait Training With Functional Electrical Stimulation in Subjects With Chronic Ankle Instability
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shmuel Springer
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability, Ankle Sprains, Sport Injury
Keywords
Chronic ankle instability, Rehabilitation, Neuromuscular control, Gait, Electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAI subjects
Arm Type
Experimental
Arm Description
Subjects in this group will receive eight 20-minutes gait training sessions with functional electrical stimulation.
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immediate change in ankle inversion angle during heel strike
Description
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.
Time Frame
immediately after the intervention
Title
Change in ankle inversion angle during heel strike at 4 weeks
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
Title
Immediate change in peroneal muscle electromyography
Description
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.
Time Frame
immediately after the intervention
Title
Change in peroneal muscle electromyography at 4 weeks
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
Secondary Outcome Measure Information:
Title
Change in Star excursion balance test (SEBT) score
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
Title
Time to stabilization (TTS)
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
Title
Peroneal reaction time (PRT)
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
Other Pre-specified Outcome Measures:
Title
Foot and Ankle Ability Measure (FAAM) - questionnaire
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
Title
Cumberland Ankle Instability Tool (CAIT) - questionnaire
Description
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.
Time Frame
through intervention completion, approximately at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Gottlieb, MSc
Phone
+972542022767
Email
urigott@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Springer, PhD
Organizational Affiliation
Ariel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ariel University
City
Ariel
ZIP/Postal Code
40700
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uri Gottlieb
Phone
0542022767
Email
urigott@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not decided yet, but optional to share all data after concealing subject's identifying details.
Learn more about this trial
Functional Electrical Stimulation in Chronic Ankle Instability
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