TENS and Taping for Older People

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05596110

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postural Defect	Behavioral: TENS and KT Behavioral: TENS and sham taping Behavioral: KT and sham TENS Behavioral: Sham TENS and sham taping	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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.	Behavioral: TENS and KT 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.	Behavioral: TENS and sham taping 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.	Behavioral: KT and sham TENS 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.	Behavioral: 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 (i.e., crosses hip joint), quadriceps (i.e., crosses the knee joint), and gastrocnemius (i.e., crosses ankle joint) of the participants.

Outcome Measures

Primary Outcome Measures

Joint active repositioning test error (using goniometry, in degree) [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shirley S.M. Fong, Principal Investigator, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05596110

Other Study ID Numbers:

First Posted:

Oct 27, 2022

Last Update Posted:

Nov 7, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 7, 2022