Effectiveness of Telerehabilitation in Balance Training Program

January 21, 2024 updated by: Intouch Amphaiphan, Siriraj Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine, Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • Intouch Amphaiphan
        • Sub-Investigator:
          • Poungkaew Thitisakulchai
        • Sub-Investigator:
          • Vilai Kuptniratsaikul
        • Sub-Investigator:
          • Thaniyaporn Claikhem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
Receive fall prevention exercise brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go test
Time Frame: 1 year
time taken to rise from a chair, walk a 3-meter distance, turn around, walk back and sit down
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five times chair stand
Time Frame: 1 year
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
1 year
Single leg stance
Time Frame: 1 year
subjects will be asked to stand on one leg as long as possible. The time obtained will be recorded
1 year
Gait speed
Time Frame: 1 year
time taken to walk at comfortable speed over a distance of 10 meters
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: INTOUCH AMPHAIPHAN, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 339/2566(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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