跳至主要内容
临床试验/NCT06210828
NCT06210828招募中不适用

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

Siriraj Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Timed Up and Go test

研究概览

简要总结

  • 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.

详细描述

  • 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Timed Up and Go test

时间窗: 1 year

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

次要结局

  • Five times chair stand(1 year)
  • Single leg stance(1 year)
  • Gait speed(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Intouch Amphaiphan

Intouch Amphaiphan, MD

Siriraj Hospital

研究点 (2)

Loading locations...

相似试验