A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients

Effects of Customized Trunk Stabilization Exercise Program to Patients With Brain Disease on Trunk Stability and Satisfaction With the Program

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Diseases
• Intervention / Treatment: Behavioral: Exercise therapy including a trunk stabilization exercise program

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MinYoung Kim, MD, PhD; Phone Number: 82-31-780-6281; Email: kmin@cha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults over 19 years old
2. Brain disease patients hospitalized in the rehabilitation medicine department of our hospital and receiving exercise therapy 5 times a week
3. Patients with a functional ambulatory category (FAC) score of 0-4
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.

Exclusion Criteria:

1. Those who have suffered prior to participating in the study
2. 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
3. Other cases of investigation without participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain disease	Behavioral: Exercise therapy including a trunk stabilization exercise program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint angle	Motion analysis is a process of measuring and evaluating kinematic parameters of joint angle(degree) of each joint through Qualisys motion analysis system.	baseline, 5 weeks after intervention
Joint moment	Evaluating kinetic parameters of joint moment (Nm/kg) of each joint through Qualisys motion analysis system.	baseline, 5 weeks after intervention
Joint power	Evaluating kinetic parameters of joint power(Nm/s*Kg) of each joint through Qualisys motion analysis system.	baseline, 5 weeks after intervention

Collaborators and Investigators

• Sponsor: Bundang CHA Hospital
• Investigators: Principal Investigator: MinYoung Kim, MD, PhD, CHA Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 21, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: 2023-11-035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No