PosturalNCT05596110
TENS and Taping for Older People
A study testing TENS and KT in people with Postural and Defect, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- What is being tested?
- TENS and KT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 60 and 75 years old
- Able to ambulate independently and safely without using any walking aid
- Able to follow instructions
Who cannot join
- 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
Show all 10Show fewer
- A change in skin sensation
- Wound around the lower limb joints
- A recent injury that may affect test performance
- Allergy to adhesive tapes
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Being tested
- TENS and KT, TENS and sham taping, KT and sham TENS, Sham TENS and sham taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS and KTBehavioural
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.
TENS and sham tapingBehavioural
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.
KT and sham TENSBehavioural
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 TENS and sham tapingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TENS and KT | Experimental | 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. Receives: Behavioral: TENS and KT |
| TENS and sham taping | Sham comparator | 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. Receives: Behavioral: TENS and sham taping |
| KT and sham TENS | Sham comparator | 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. Receives: Behavioral: KT and sham TENS |
| Sham TENS and sham taping | Sham comparator | 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. Receives: Behavioral: Sham TENS and sham taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint active repositioning test error (using goniometry, in degree)
Lower limb joint proprioception test - Joint active repositioning error of the hip, knee and ankle joints of both lower limbs
Measured: Day 1 to Day 4
Secondary outcomes (4)
Center of pressure (COP) sway path length in static single-leg standing (using a force platform, in cm)
Static single-leg standing balance performance - COP sway path length in static single-leg standing
Measured: Day 1 to Day 4
Center of pressure (COP) sway velocity in static single-leg standing (using a force platform, in m/s)
Static single-leg standing balance performance - COP sway velocity in static single-leg standing
Measured: Day 1 to Day 4
Functional Reach Test score (using a cloth measuring tape, in cm)
Limits of stability balance performance - Functional Reach Test score
Measured: Day 1 to Day 4
Timed Up-and-Go Test completion time (using a stop watch, in s)
Functional balance performance - Timed Up-and-Go Test completion time
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PosturalStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley S.M. Fong, Chinese University of Hong Kong
- Investigators
- Shirley SM Fong, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596110
- Sponsor's protocol ID
- CU1
- Status last verified
- Nov 2022
- First submitted
- 15 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05596110
- Acronym / sponsor ID
- CU1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TENS and KT | Experimental | Behavioral: TENS and KTTENS 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 and sham taping | Sham comparator | Behavioral: TENS and sham tapingTENS 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. |
| KT and sham TENS | Sham comparator | Behavioral: KT and sham TENSKT 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. |
| Sham TENS and sham taping | Sham comparator | Behavioral: Sham TENS and sham tapingSham 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 60 and 75 years old
- Able to ambulate independently and safely without using any walking aid
- Able to follow instructions
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS and KTTENS 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. | Behavioural | TENS and KT |
| TENS and sham tapingTENS 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. | Behavioural | TENS and sham taping |
| KT and sham TENSKT (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. | Behavioural | KT and sham TENS |
| Sham TENS and sham tapingSham 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. | Behavioural | Sham TENS and sham taping |
Primary outcome
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
4 secondary outcomes
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
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
Functional Reach Test score (using a cloth measuring tape, in cm)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley SM Fong, PhD principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing TENS and KT in people with Postural and Defect, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley SM Fong, PhD (+852 97090337, smfong_2004@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint active repositioning test error (using goniometry, in degree) (time frame: Day 1 to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.