NCT02868840

Brief Summary

Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the integration and balance of mind and body using the fundamental principles of slow, smooth, and continuous movement control, and the transfer of body weight while maintaining an upright and relaxed posture. The present randomized clinical trial project aims to apply the suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to evaluate the effects on physical (balance), psychological, and cognitive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

July 27, 2016

Last Update Submit

September 11, 2017

Conditions

Stroke

Keywords

strokeTai jipostural balancecognition

Outcome Measures

Primary Outcomes (1)

  • balance

    postural stability test will be measured by standard computerized test

    3 months, 6 months

Secondary Outcomes (2)

  • activities of daily living

    3 months, 6 months

  • knee muscle strength

    3 months, 6 months

Other Outcomes (1)

  • cognition

    3 months, 6 months

Study Arms (2)

Tai Chi group

EXPERIMENTAL

Tai Chi exercise, twice a week, one hour per session. participated in Tai Chi either while seated or standing upon their comfort level.

Behavioral: Tai Chi exercise

Symptom management group

ACTIVE COMPARATOR

manage stroke symptom through phone and text message along with other rehabilitation therapy.

Behavioral: symptom management

Interventions

Tai Chi exerciseBEHAVIORAL

exercise twice a week each for one hour

Also known as: seated Tai Chi
Tai Chi group
symptom managementBEHAVIORAL

sending text message weekly to manage symptoms related to stroke

Also known as: message counselling
Symptom management group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed as stroke at least for 3 months upto 2 years
  • eligible to participate rehabilitation therapy referred by primary physician

You may not qualify if:

  • not able to understand questionnaires
  • not able to stand alone for balance test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Related Publications (2)

  • Chen BL, Guo JB, Liu MS, Li X, Zou J, Chen X, Zhang LL, Yue YS, Wang XQ. Effect of Traditional Chinese Exercise on Gait and Balance for Stroke: A Systematic Review and Meta-Analysis. PLoS One. 2015 Aug 20;10(8):e0135932. doi: 10.1371/journal.pone.0135932. eCollection 2015.

    PMID: 26291978BACKGROUND

  • Tao J, Rao T, Lin L, Liu W, Wu Z, Zheng G, Su Y, Huang J, Lin Z, Wu J, Fang Y, Chen L. Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial. BMC Complement Altern Med. 2015 Feb 25;15:31. doi: 10.1186/s12906-015-0555-1.

    PMID: 25888114BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Aquatic TherapyPalliative Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rhayun Song, PhD

    Chungnam National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 16, 2016

Study Start

January 1, 2016

Primary Completion

March 30, 2017

Study Completion

June 30, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)