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Completed

NCT Number: NCT05790369

Effects of Home-Based Ankle Training Program on The Muscle Strength, Balance and Gait Function in the Elderly

The occurrence of frequent falls influences the independence of the elderly's physical functions, and the factors related to falls include: weakness in the lower limbs, age, past injury experiences and so forth. Prolonged inactivity also increases the risk of falls, which is subsequently prone to bringing about other complications, which enhances the odds of falling again on the elderly.

In the literature, training methods for the lower limbs were for the most part of complex training, whereas only a few studied on the single part training. In locomotion, the ankle first touches the ground, needing strong ankle muscular strength to support the body. Nevertheless, previous studies rarely mentioned whether a single ankle muscular strength could reduce the risk of falls.

Traditionally, the training of ankle muscular strength practically utilizes elastic bands, and there are plenty of benefits confirmed in the literature. However, it is even harder to implement the operation in reality, especially in the elderly. To resolve this problem effectively, a new type of ankle training machine is added to this study. It can be adjusted to different levels of resistance, provide multi directional training, and allow the subjects to be trained in a sitting position achieving a stable state. In addition, this machine is easy to operate for the elderly.

The aims of this research are: (1) to propose two different types of ankle training methods and designed a 6 week training programs, (2) to explore whether the training programs can improve muscular strength, balance capacity and gait function and (3) compare the training effects between the two types of ankle training methods. In this study, 60 voluntary old citizens, aged over 65, will be recruited, and they will be randomly divided into: 30 members in the Elastic Band Training Group (EBTG) and 30 members in the New Ankle Training Machine Training Group (NAMTG). During the six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks; meanwhile, coaches can affirm whether the plan is executed properly, confirming the effectiveness of the home training. Through these two groups of home ankle training programs with different interventional approaches lasting six weeks, the objective of the intervention is to boost muscular strength, balance ability as well as gait ability, meanwhile to decline the risk of falls and to reduce high medical expenses and care labor costs.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 40402, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy elderly people over 65 years old have no exercise habits.
  • The ability to walk independently or without equipment is at least 10m.
  • Able to independently perform activities related to daily life, such as doing housework, walking, climbing stairs, etc.
  • Elderly people who have a history of minor stroke or upper limb surgery but have not affected the ankle movement can be included in the scope of the case.

Exclusion criteria

  • There is a musculoskeletal system disease, or the movement of the limbs is severely restricted.
  • If there is a history of lower limb surgery, which affects neurological symptoms and mobility, it is excluded.
  • Exclude specific diseases, such as stroke, spinal cord injury,etc., who have obvious sequelae of movement.
  • Participated in other programs including Muscular strength, Balance ability, Gait function training, etc. in the past 6 months

Treatment and study plan

Resistance training (New ankle machine training)

Behavioral

A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks.

Resistance training (Elastic band training )

Behavioral

A six week workout plan, the subjects receive on site or online guidance from professional coaches every two weeks.

Primary outcomes

  1. Muscle strength test

    Time frame: Change from Baseline (before the training) at the completion of 6 weeks training

    Sit-to-stand test, recoding by the time in seconds

  2. Postural stability test

    Time frame: Change from Baseline (before the training) at the completion of 6 weeks training

    One-leg standing with eye-open and eye-closed, recoding by the the center of pressure from a force plate

  3. Y- balance test

    Time frame: Change from Baseline (before the training) at the completion of 6 weeks training

    Recoding the distance in the anterior, posterio-medial and posterio-lateral in cm.

  4. Gait analysis

    Time frame: Change from Baseline (before the training) at the completion of 6 weeks training

    Recoding the joint angle in degrees by the IMU sensors.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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