NCT06274463

Brief Summary

To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 4, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 4, 2024

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Trunk Impairment Scale

    Trunk impairment scale assessment for motor function of upper extremity in score. This evaluation consists of a total score of 23 points and consists of static sitting balance, dynamic sitting balance, and co-ordination. The higher the score, the better the upper extremity motor function.

    baseline, 5 weeks after intervention

  • Berg Balance Scale

    Berg balance scale assessment of balance function by score. It consists of a total of 14 items and is divided into three parts: sitting, standing, and posture change. The minimum score is 0 points, up to 4 points for discharge, and the total total score is 56 points. A higher score means higher balance ability and lower risk of falling.

    baseline, 5 weeks after intervention

Secondary Outcomes (3)

  • Joint angle

    baseline, 5 weeks after intervention

  • Joint moment

    baseline, 5 weeks after intervention

  • Joint power

    baseline, 5 weeks after intervention

Study Arms (1)

Brain disease

EXPERIMENTAL
Behavioral: Exercise therapy including a trunk stabilization exercise program

Interventions

All patients will undergo 30 sessions of exercise therapy, including a trunk stability exercise program, for 30 minutes per day, 5 days a week for 6 weeks

Brain disease

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 19 years old
  • Brain disease patients hospitalized in the rehabilitation medicine department of our hospital and receiving exercise therapy 5 times a week
  • Patients with a functional ambulatory category (FAC) score of 0-4
  • After receiving a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to follow the precautions.

You may not qualify if:

  • Those who have suffered prior to participating in the study
  • Those in good physical condition, such as unstable conditions in the state system, coordination system, problem system, and endocrine system, and those with cerebrovascular disease
  • Other cases of investigation without participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • MinYoung Kim, MD, PhD

    CHA Bundang Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MinYoung Kim, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 23, 2024

Study Start

February 21, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02