- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05596110
TENS and Taping for Older People
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
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shirley SM Fong, PhD
- Phone Number: +852 97090337
- Email: smfong_2004@yahoo.com.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Shirley SM Fong, PhD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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