NCT04148768

Brief Summary

Background: The Y balance test is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals. The test can be used to assess physical performance, but can also be used to screen deficits in dynamic postural control due to musculoskeletal injuries (e.g. chronic ankle instability), to identify athletes at greater risk for lower extremity injury, as well as during the rehabilitation of orthopedic injuries in healthy active adults Objective: To know the effect of 4 sessions of treatment by interferential therapy (IFT) 15-20 minutes, and SWD 15 min on the balance and dynamic postural component using Y balance test Methods: Subjects will be randomized into IFT and laser group (n=20 each). After the first session, the balance component will be measured pre-post-intervention. Outcome assessment: Y Balance tests score.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

November 30, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

October 29, 2019

Last Update Submit

February 8, 2021

Conditions

Keywords

Knee painosteoarthritis,patello-femoral pain,Anetrior cruciate repairBalanceDynamic and static balanceProprioception

Outcome Measures

Primary Outcomes (1)

  • Y balance test Score

    More condensed form of star excursion test. Used to evaluate dynamic balance

    Change is being evaluated from Baseline and at 4 week

Secondary Outcomes (1)

  • Visual analogue scale

    Change is being evaluated from Baseline and at 4 week

Study Arms (2)

Inferential therapy

ACTIVE COMPARATOR

Interferential therapy will be given using 4 electrode methods. The 'medium frequency' currents (medium frequency in electromedical terms is usually considered to be 1KHz-100KHz). These medium frequency currents, passed through the tissues simultaneously, where they are set up so that their paths cross \& they literally interfere with each other. This interaction gives rise to an interference current (or beat frequency) which has the characteristics of low-frequency stimulation. Pre-Post Y balance test will be used after 4 sessions to measure the improvement in balance in the population

Device: Inferential therapy

Shortwave diathermy

ACTIVE COMPARATOR

4 sessions of treatment will be given to the participants with SWD. Pre-post Y balance test will be used to measure balance in the population

Device: short wave diathermy

Interventions

Interferential therapy(IFT) utilises two of these medium frequency currents, passed through the tissues simultaneously, where they are set up so that their paths cross \& they literally interfere with each other - hence another term that has been used in the past but appears to be out of favour at the moment - Interference Current Therapy. This interaction gives rise to an interference current (or beat frequency) which has the characteristics of low-frequency stimulation.

Inferential therapy

SWD: Technical specification of Generator frequency: 27.12 MHz, ± 0.6% Output power: continuous High-Frequency max. 400 W, pulsed High-Frequency max. 1000 W (peak) Pulse duration: ca. 400 µs Pulse repetition frequency: 15-200 Hz adjustable in 10 steps Mains supply: 230-240 V / 50 Hz Mains voltage variation: approx. ± 10% Current consumption: approx. 6 Ampere (at 230 V)

Shortwave diathermy

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-specific Knee pain,
  • osteoarthritis,
  • chronic ACL and meniscus injury,
  • patellofemoral knee pain

You may not qualify if:

  • Recent major surgeries within 6 months,
  • Limb Length discrepancies, amputation,
  • any musculoskeletal or neurological limitation preventing evaluation,
  • vitamin deficiency (B12),
  • neuropathy,
  • cancer-related patients,
  • rheumatoid arthritis,
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khalid University

Abhā, 'Asir Region, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Chronic PainOsteoarthritis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • snehil dixit, PhD

    King Khalid University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

snehil dixit, PHD

CONTACT

snehil dixit, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of the treatment groups given to them.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention SWD \& IFT: 4 SESSIONS OF TREATMENT and measurement of balance
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor , Department of Medical Rehabilitation

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 4, 2019

Study Start

November 30, 2019

Primary Completion

April 27, 2021

Study Completion

June 15, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations