TENS and Taping for Older People

November 2, 2022 updated by: Shirley S.M. Fong, The University of Hong Kong

Acute Effects of Transcutaneous Electrical Nerve Stimulation and Kinesio Taping on Lower Limb Joint Proprioception, Static Standing Balance, Limits of Stability and Functional Balance Performance in Community-dwelling Older Adults

Aim: To examine the acute effects of transcutaneous electrical nerve stimulation (TENS) and Kinesio Taping (KT) on lower limb joint proprioception, static standing balance, limits of stability and functional balance performance in community-dwelling older adults.

Design: A one-group experimental study with a repeated-measures design. Sample: 24+ community-dwelling older adults Interventions: TENS and KT, TENS and sham taping, KT and sham TENS, and sham TENS and sham taping (30 minutes each) Major outcomes: Outcomes will be evaluated during each of the intervention conditions. Lower limb joint active repositioning error will be evaluated using a joint position sense test; a force platform will be used to assess the single-leg standing body sway path length and velocity; a functional reach test will give a score that reflects the limits of stability of the participants; and the timed up-and-go test will be used to quantify functional balance performance of the participants.

Anticipated results and significance: It is predicted that both TENS and KT, when applied together, may best improve lower limb joint proprioception and facilitate all balance performances among the community-dwelling older adults. These interventions could be applied in clinical settings to improve joint proprioception and postural control of the elderly people.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Between 60 and 75 years old
  • Able to ambulate independently and safely without using any walking aid
  • Able to follow instructions

Exclusion criteria:

  • Known unstable medical condition (e.g., uncontrolled hypertension)
  • Known sensorimotor or neurological disorders (e.g., stroke and epilepsy)
  • Significant musculoskeletal disorder of the lower limbs (e.g., osteoarthritis of the knee)
  • Cognitive disorder
  • Presence of an implanted electrical device (e.g., cardiac pacemaker)
  • Cancer
  • A change in skin sensation
  • Wound around the lower limb joints
  • A recent injury that may affect test performance
  • Allergy to adhesive tapes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS and KT
TENS will be applied on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs. In addition, KT will be applied to major postural muscles including the bilateral gluteus medius, quadriceps, and gastrocnemius of the participants.
TENS will be delivered using three E704SD TIMER TENS devices (or similar) through pairs of electrodes placed on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs. In addition, KT (Kinesio Tex Gold) will be applied to major postural muscles including the bilateral gluteus medius (i.e., crosses hip joint), quadriceps (i.e., crosses the knee joint), and gastrocnemius (i.e., crosses ankle joint) of the participants.
Sham Comparator: TENS and sham taping
TENS will be applied on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs. In addition, sham tapes will be applied to major postural muscles including the bilateral gluteus medius, quadriceps, and gastrocnemius of the participants.
TENS will be delivered using three E704SD TIMER TENS devices (or similar) through pairs of electrodes placed on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs. In addition, sham tapes will be applied to major postural muscles including the bilateral gluteus medius (i.e., crosses hip joint), quadriceps (i.e., crosses the knee joint), and gastrocnemius (i.e., crosses ankle joint) of the participants.
Sham Comparator: KT and sham TENS
KT will be applied to major postural muscles including the bilateral gluteus medius, quadriceps, and gastrocnemius of the participants. In addition, sham TENS will be applied on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs.
KT (Kinesio Tex Gold) will be applied to major postural muscles including the bilateral gluteus medius (i.e., crosses hip joint), quadriceps (i.e., crosses the knee joint), and gastrocnemius (i.e., crosses ankle joint) of the participants. In addition, sham TENS will be applied on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs.
Sham Comparator: Sham TENS and sham taping
Sham TENS will be applied on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs. In addition, sham tapes will be applied to major postural muscles including the bilateral gluteus medius, quadriceps, and gastrocnemius of the participants.
Sham TENS will be applied on the medial and lateral joint lines of the knee and ankle joints and the anterior and posterior joint lines of the hip joint of both legs. In addition, sham tapes will be applied to major postural muscles including the bilateral gluteus medius (i.e., crosses hip joint), quadriceps (i.e., crosses the knee joint), and gastrocnemius (i.e., crosses ankle joint) of the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint active repositioning test error (using goniometry, in degree)
Time Frame: Day 1 to Day 4
Lower limb joint proprioception test - Joint active repositioning error of the hip, knee and ankle joints of both lower limbs
Day 1 to Day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center of pressure (COP) sway path length in static single-leg standing (using a force platform, in cm)
Time Frame: Day 1 to Day 4
Static single-leg standing balance performance - COP sway path length in static single-leg standing
Day 1 to Day 4
Center of pressure (COP) sway velocity in static single-leg standing (using a force platform, in m/s)
Time Frame: Day 1 to Day 4
Static single-leg standing balance performance - COP sway velocity in static single-leg standing
Day 1 to Day 4
Functional Reach Test score (using a cloth measuring tape, in cm)
Time Frame: Day 1 to Day 4
Limits of stability balance performance - Functional Reach Test score
Day 1 to Day 4
Timed Up-and-Go Test completion time (using a stop watch, in s)
Time Frame: Day 1 to Day 4
Functional balance performance - Timed Up-and-Go Test completion time
Day 1 to Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shirley SM Fong, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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