NCT04141384

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

October 24, 2019

Last Update Submit

October 27, 2019

Conditions

Keywords

Modular Interactive Tiles System, MITSStroke

Outcome Measures

Primary Outcomes (1)

  • Center of pressure, COP

    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.

    50minute

Study Arms (2)

General rehabilitation+Modular Interactive Tiles System, MITS

OTHER

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.

Device: Modular Interactive Tiles System, MITS

General rehabilitation

NO INTERVENTION

Subjects were randomly assigned to the experimental or control group after completing the Berg scale test before the experiment.In the control group, each training time was 45 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.

Interventions

The modular robotic brick system was developed by Danish scholar Prof. Henrik Hautop Lund in collaboration with the University of Siena in Italy to develop a new tool. The system uses the design principles of different levels of daily life activities, combined with the way of cognitive games, Lego toys can combine different game concepts, with a set of individual or multi-person activity programs with hands or feet, provide a set Modular floor tiles for stroke patients and the elderly.

General rehabilitation+Modular Interactive Tiles System, MITS

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Stage1
  • unable to stand with the feet and the walker;
  • pregnant;
  • within six months will affect the walking or standing surgery (such as limbs, spine or brain surgery);
  • other Physical and mental state is not suitable.
  • Stage2
  • unable to stand and walk with both feet;
  • 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;
  • suffering from hemophilia Patients with diseases, other blood-related diseases or severe peripheral vascular diseases;
  • those who are pregnant;
  • those who have been affected by walking or standing within six months (such as limb, spine or brain surgery);
  • Other physical and mental states are not suitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Stage 1-NO intervention Stage 2-To explore the possibility of enhancing the balance of stroke patients by stimulating the modular robotic brick system. Control group-General rehabilitation Study group-General rehabilitation+Modular Interactive Tiles System(MITS)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

May 1, 2014

Primary Completion

December 31, 2014

Study Completion

July 31, 2015

Last Updated

October 29, 2019

Record last verified: 2019-10