A Study of the Effects of External Stimulations on Postural Stability

Not Applicable

Completed

• Conditions: Postural Stability
• Interventions: Device: Modular Interactive Tiles System, MITS

• Registration Number: NCT04141384
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

In view of the long-term exercise, you can maintain your health and strengthen your physical strength. It can also improve your body's balance and help maintain your body's coordination so that you can reduce the chance of falls.

Therefore, in the face of aging, stroke rehabilitation or balance of power caused by balance of power decline, sports injuries or falls related issues, this study will focus on "balance ability" to explore a range of impacts and relationships.

Detailed Description

Considering the standardization comparison in the study, this study will collect data on the balance of young people under different external stimuli, and hope to understand the balance control ability by objectively collecting the physiological signals of the Center of Pressure (COP).

The change, and the use of the Berg scale as a benchmark for the assessment of balance ability, and then return to the issue of balance ability training.

Therefore, this study divides the experiment into two major stages. The first stage will focus on healthy young people, and explore how external stimuli affect balance, and then assist balance ability training to find the most appropriate adjustment of body posture control.

The second phase explores the appropriate exercise training for stroke patients, such as the use of Modular Interactive Tiles System (MITS) training, to track the effectiveness of external stimulus impact balance training.

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2014-12-31
• Study Completion: 2015-07-31
• Status Verified: 2019-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Last Update Submitted: 2019-10-27
• Study First Posted: 2019-10-28
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Stage1 Subjects were included in the condition of adults with good health and no mobility disorder. They will be considered by healthy young people over the age of 20.

It is estimated that 12 males and 12 females will be called.

• Stage2 Forty patients with a stroke of more than six months have been admitted.

Subjects were included as follows:

1. stroke for more than 6 months;
2. current stable condition;
3. able to walk independently for more than 5 meters, and if necessary, use auxiliary equipment;
4. before and after the two feet Stand in a straight line for more than 10 seconds;
5. can understand spoken instructions.

Exclusion Criteria

• Stage1

  1. unable to stand with the feet and the walker;
  2. pregnant;
  3. within six months will affect the walking or standing surgery (such as limbs, spine or brain surgery);
  4. other Physical and mental state is not suitable.

• Stage2

  1. unable to stand and walk with both feet;
  2. suffering from diabetes or other diseases combined with peripheral neuropathy, causing a poor sense of body or a neurological disease affecting lower limb movement and sensory function;
  3. suffering from hemophilia Patients with diseases, other blood-related diseases or severe peripheral vascular diseases;
  4. those who are pregnant;
  5. those who have been affected by walking or standing within six months (such as limb, spine or brain surgery);
  6. Other physical and mental states are not suitable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General rehabilitation+Modular Interactive Tiles System, MITS	Modular Interactive Tiles System, MITS	Subjects were randomly assigned to the experimental or control group after completing the Berg scale test before the experiment. In the experimental group, external stimulation (MITS) was added, and the training time was 65 minutes. Before the start of the experiment and after the training every 4 weeks, each group must carry out the Berg scale and balance assessment.

Primary Outcome Measures

Name	Time	Method
Center of pressure, COP	50minute	The experiment will collect the COP signals of the participants in different situations through the force plate, and judge the external stimuli to influence the balance by measuring the results.