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Postural BalanceNCT06210828

Effectiveness of Telerehabilitation in Balance Training Program

A study testing Telerehabilitation in people with Postural Balance and Fall, run by Siriraj Hospital at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness of telerehabilitation for fall prevention. Participants are randomly assigned to telerehabilitation group or control group. Both the telerehabilitation and control groups will receive fall prevention education. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Postural Balance, Fall
What is being tested?
Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteThailand
Study dates
1 Nov 2023to 31 Mar 2025
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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Elderly aged ≥ 60 years walking independently with or without gait aid use
  • Had a history of falling at least 1 time within the past year.
  • Participants or their caregivers have an ability to use telemedicine (LINE video call), read and understand a brochure.

Who cannot join

  • Those who have unstable medical conditions influenced their gait and mobility such unstable cardiopulmonary problem, non-heal fracture and severe arthritis and a cognitive impairment limited learning ability to exercise will be excluded.

Trial locations and contacts

1 site in 1 country.

Thailand1 site, 1 recruiting
  • Faculty of medicine, Siriraj Hospital

    Bangkok Noi, Bangkok, 10700

    INTOUCH AMPHAIPHAN, +66863919784, aintouchamphaiphan@gmail.com

    Intouch Amphaiphan

    Recruiting

Other trials in Thailand

About this study

Official title: Effectiveness of Telerehabilitation in Balance Training Program Among Elderly at Risk of Falling, a Randomized Controlled Trial

  • The purpose of this study is to assess the effectiveness of telerehabilitation for fall prevention.
  • Participants are randomly assigned to telerehabilitation group or control group.
  • Both the telerehabilitation and control groups will receive fall prevention education.
  • In addition, both groups will receive a fall prevention exercise brochure that includes instructions on how to perform the exercises, the recommended repetition and number of sets.
  • The telerehabilitation group engages in two exercise sessions per week for a duration of 12 weeks at home. The session will be led by a physical therapist via telerehabilitation (LINE video call).
  • All participants are advised to perform exercise for a total 3 days/week and record in the log book.
  • Participants are evaluated for balancing abilities using tests including: Timed Up and Go test, Five times chair stand, Single leg stance, Gait speed, Number of fall at 3 month, 6 month, 1 year.
Read the detailed description
  • The investigators distribute invitation flyers for enrollment throughout Siriraj Hospital. Participants who comply with the eligibility criteria, can contact the researcher or outpatient clinic rehabilitation nurse to schedule an appointment.
  • When a patient is willing to participate in the research, the researcher will provide the consent form for the participant to sign.
  • After participants sign the informed consent, demographic data including age, sex, body weight, height, BMI, living status, educational status, functional status, gait aid use, underlying diseases, fall history, drug use, cognitive function and home environment. Baseline physical performance including Timed Up and Go test, five times chair stand, Single leg stance and gait speed are also recorded in case record form at outpatient clinic rehabilitation by an assessor who are blinded to group allocation.
  • Participants are randomly assigned to telerehabilitation groups or control group with a simple randomization with a ratio of 1:1. Generate random sequence lists by an investigator who is not involved in data collection or administering interventions. The sequence generation lists are then concealed by using opaque-sealed envelopes.

Both the telerehabilitation and control groups will receive fall prevention education from a doctor after participation and checking during visiting at the outpatient clinic (the first visit, and then at 3 months, 6 months, and 1 year).

  • In addition, both groups will receive a fall prevention exercise brochure that includes instructions on how to perform the exercises, the recommended repetition and number of sets.
  • The telerehabilitation group engages in two exercise sessions per week for a duration of 12 weeks at home. The session will be led by a physical therapist via two way communication telerehabilitation (LINE video call). The physical therapist will record each session participated.
  • Each session starts with a 10 minute warm-up, followed by 40 minutes of strengthening and balance training and ending with 10 minutes cool-down. The exercise program consists of two levels. After completing the first level for a month, participants will progress to the second level.
  • Level 1 involved various exercises included: strengthening exercise emphasizing standing hip abductors; standing hip extensors; standing knee extensor; heel rise and balance exercise including sit to stand; marching, triangle step, side way walks.
  • Level 2 increase in intensity of training by use an elastic band on the lower extremities during strengthening exercises. Additionally, to enhance the difficulty of balance training, reducing hand support are perform during balance exercise. The investigators will be recruiting 1-3 participants for a group of telerehabilitation.
  • All participants are advised to perform exercise for a total 3 days/week and record in the log book
  • Participants are evaluated for balancing abilities using tests including: Timed Up and Go test, Five times chair stand, Single leg stance, Gait speed, Number of fall at 3 month, 6 month, 1 year.
  • All of the tests are conducted sequentially at baseline, after 3 months, 6 months, 1 years by an assessor who are blinded to group allocation.
Being tested
Telerehabilitation, Control
Keywords
Physical Performance, Falling, Elderly, Telerehabilitation, Telerehab, Telemedicine, Exercise, Telehealth
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabilitationBehavioural

    Two weekly exercise sessions over a 12-week period at home via LINE Video call with physical therapist. Focusing on lower extremity strengthening and balance exercises. In addition to the guided sessions, participants are encouraged to perform self-directed exercises one day per week.

  • ControlBehavioural

    Receive fall prevention exercise brochure

Study groups in NCT06210828
Study groupRoleWhat they receive
Telerehabilitation GroupExperimentalA telerehabilitation group participates in two weekly exercise sessions over a 12-week period at home. These sessions, led by a physical therapist through two-way communication, focus on lower extremity strengthening and balance exercises. In addition to the guided sessions, participants are encouraged to perform self-directed exercises one day per week.
Receives: Behavioral: Telerehabilitation
Control GroupActive comparator* Receive fall prevention exercise brochure that includes instructions on how to perform the exercises, the recommended repetition and number of sets. * Participants are suggested to perform self-directed exercises three day per week.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed Up and Go test

    time taken to rise from a chair, walk a 3-meter distance, turn around, walk back and sit down

    Measured: 1 year

Secondary outcomes (3)
  1. Five times chair stand

    subjects will be asked to rise from a standard height chair five times, as fast as possible and time-spent will be recorded, as the time from the initial seated position to the final seated position after completing five stands

    Measured: 1 year

  2. Single leg stance

    subjects will be asked to stand on one leg as long as possible. The time obtained will be recorded

    Measured: 1 year

  3. Gait speed

    time taken to walk at comfortable speed over a distance of 10 meters

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start1 Nov 2023
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06210828
Sponsor's protocol ID
339/2566(IRB3)
Status last verified
Jan 2024
First submitted
8 Jan 2024
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Clark RD, Lord SR, Webster IW. Clinical parameters associated with falls in an elderly population. Gerontology. 1993;39(2):117-23. doi: 10.1159/000213521.

    PubMed 8514201
  • Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.

    PubMed 27707740
  • Gardner MM, Buchner DM, Robertson MC, Campbell AJ. Practical implementation of an exercise-based falls prevention programme. Age Ageing. 2001 Jan;30(1):77-83. doi: 10.1093/ageing/30.1.77.

    PubMed 11322678
  • Kwak CJ, Kim YL, Lee SM. Effects of elastic-band resistance exercise on balance, mobility and gait function, flexibility and fall efficacy in elderly people. J Phys Ther Sci. 2016 Nov;28(11):3189-3196. doi: 10.1589/jpts.28.3189. Epub 2016 Nov 29.

    PubMed 27942147
  • Kuptniratsaikul V, Praditsuwan R, Assantachai P, Ploypetch T, Udompunturak S, Pooliam J. Effectiveness of simple balancing training program in elderly patients with history of frequent falls. Clin Interv Aging. 2011;6:111-7. doi: 10.2147/CIA.S17851. Epub 2011 May 6.

    PubMed 21594001
  • Zhuang J, Huang L, Wu Y, Zhang Y. The effectiveness of a combined exercise intervention on physical fitness factors related to falls in community-dwelling older adults. Clin Interv Aging. 2014;9:131-40. doi: 10.2147/CIA.S56682. Epub 2014 Jan 10.

    PubMed 24453483
  • Leslie S, Tan J, McRae PJ, O'leary SP, Adsett JA. The Effectiveness of Exercise Interventions Supported by Telerehabilitation For Recently Hospitalized Adult Medical Patients: A Systematic Review. Int J Telerehabil. 2021 Dec 16;13(2):e6356. doi: 10.5195/ijt.2021.6356. eCollection 2021.

    PubMed 35646230
  • Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.

    PubMed 30324099
  • Peretti A, Amenta F, Tayebati SK, Nittari G, Mahdi SS. Telerehabilitation: Review of the State-of-the-Art and Areas of Application. JMIR Rehabil Assist Technol. 2017 Jul 21;4(2):e7. doi: 10.2196/rehab.7511.

    PubMed 28733271
  • Bernocchi P, Giordano A, Pintavalle G, Galli T, Ballini Spoglia E, Baratti D, Scalvini S. Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):340-346. doi: 10.1016/j.jamda.2018.09.003. Epub 2018 Oct 23.

    PubMed 30366759
  • Ranaweera AD, Fonseka P, PattiyaArachchi A, Siribaddana SH. Incidence and risk factors of falls among the elderly in the District of Colombo. Ceylon Med J. 2013 Sep;58(3):100-6. doi: 10.4038/cmj.v58i3.5080.

    PubMed 24081169
  • Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.

    PubMed 24484314
  • Tiedemann A, Shimada H, Sherrington C, Murray S, Lord S. The comparative ability of eight functional mobility tests for predicting falls in community-dwelling older people. Age Ageing. 2008 Jul;37(4):430-5. doi: 10.1093/ageing/afn100. Epub 2008 May 16.

    PubMed 18487264
  • Chang CJ, Chang YS, Yang SW. Using single leg standing time to predict the fall risk in elderly. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:7456-8. doi: 10.1109/EMBC.2013.6611282.

    PubMed 24111469
  • Hong C. Gait Speed Cut-Off Point as a Predictor of Fall in Community-Dwelling Older Adults: Three-Year Prospective Finding from Living Profiles of Elderly People Surveys in Korea. KJFP 2016;6:105-110.

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation in people with Postural Balance and Fall, run by Siriraj Hospital at 1 site in Thailand.

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 1 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 INTOUCH AMPHAIPHAN (+66863919784, aintouchamphaiphan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go test (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06210828, which also lists 17 linked publications.

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 23 Jan 2024.

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