NCT02817399

Brief Summary

The purpose of this study is to examine the short term effect of functional electrical stimulation treatment versus neuro-muscular electrical stimulation on gait quality for patient after anterior cruciate ligament reconstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 13, 2022

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

March 15, 2016

Last Update Submit

December 12, 2022

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

anterior cruciate ligament reconstructionFunctional Electrical stimulationGait analysisPhysical therapy

Outcome Measures

Primary Outcomes (1)

  • Percentages of single support at each leg

    The test will perform with the Optogait system (a device for the Gait Analysis). Single support phase within the gait cycle during which the body mass is carried by a single limb. This parameter calculated by percentage of stride (normally about 40%).

    One year

Secondary Outcomes (4)

  • strength symmetry

    One year

  • Gait speed

    One year

  • Step length

    One year

  • Quadriceps strength

    One year

Study Arms (2)

Neuro-muscular electrical stimulation

ACTIVE COMPARATOR

Active exercises \& Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting).

Device: Neuro-muscular electrical stimulationProcedure: Active exercises

Functional electrical stimulation

EXPERIMENTAL

Active exercises \& Functional electrical stimulation while walking.

Device: Functional electrical stimulationProcedure: Active exercises

Interventions

Functional electrical stimulationDEVICE

Electrical stimulation that cause muscle contraction while walking

Functional electrical stimulation
Neuro-muscular electrical stimulationDEVICE

Electrical stimulation that cause muscle contraction in a stationary position

Neuro-muscular electrical stimulation
Active exercisesPROCEDURE

Subjects will receive training exercise according to ACL reconstruction protocol

Functional electrical stimulationNeuro-muscular electrical stimulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Intended patients for ACL reconstruction procedure
  • Age 18-30
  • Committed for three sessions per week for 4 weeks

You may not qualify if:

  • Previous surgery at the same knee
  • Chronic knee swelling
  • Knee injury
  • History of recurrent ankle sprains, Achilles tendinopathy, or lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zrifin

Rishon LeZiyyon, Doar Tsvai, 03529, Israel

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Shmuel Springer, Ph.d

    Physiotherapy department, school of Health Sciences, Ariel University, ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

June 29, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

December 13, 2022

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)