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RecruitingNCT06210828Updated Jan 23, 2024

Effectiveness of Telerehabilitation in Balance Training Program

An interventional study of Telerehabilitation and Control in Postural Balance and Fall, sponsored by Siriraj Hospital. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Siriraj Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.
  • 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.
02

Conditions studied

  • Postural Balance
  • Fall

Keywords

  • Physical Performance
  • Falling
  • Elderly
  • Telerehabilitation
  • Telerehab
  • Telemedicine
  • Exercise
  • Telehealth
03

In context

Lead sponsor

Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Telerehabilitation Group

    A 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.

    Behavioral: Telerehabilitation

  • Active comparator
    Control Group

    * 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.

    Behavioral: Control

Interventions

  • BehavioralTelerehabilitation

    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.

  • BehavioralControl

    Receive fall prevention exercise brochure

06

What researchers measure

Primary outcomes

  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

    Time frame: 1 year

Secondary outcomes

  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

    Time frame: 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

    Time frame: 1 year

  3. Gait speed

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine, Siriraj Hospital
    Bangkok Noi, Bangkok 10700, Thailand
    • INTOUCH AMPHAIPHAN · Contact · aintouchamphaiphan@gmail.com · +66863919784
    • Intouch Amphaiphan · Principal investigator
    • Poungkaew Thitisakulchai · Sub investigator
    • Vilai Kuptniratsaikul · Sub investigator
    • Thaniyaporn Claikhem · Sub investigator
    Recruiting
08

References and documents

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.
  • Kis O, Buch A, Stern N, Moran DS. Minimally supervised home-based resistance training and muscle function in older adults: A meta-analysis. Arch Gerontol Geriatr. 2019 Sep-Oct;84:103909. doi: 10.1016/j.archger.2019.103909. Epub 2019 Jul 8. PubMed 31301519 ↗
  • Ninlerd C, Dungkong S, Phuangphay G, Amornsupak C, Narkbunnam R. Effect of home-based rehabilitation exercise program for elderly patients with femoral neck fracture after bipolar hemiarthroplasty. Siriraj Med J. 2020; 72(4): 307-14

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06210828
Lead sponsor
Siriraj Hospital
Responsible party
Intouch Amphaiphan (Intouch Amphaiphan, MD, Siriraj Hospital) — Principal investigator
First posted
Jan 18, 2024
Start date
Nov 1, 2023
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jan 23, 2024

Study contacts

INTOUCH AMPHAIPHAN
Contact
aintouchamphaiphan@gmail.com
+66863919784
INTOUCH AMPHAIPHAN
principal investigator · Siriraj Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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