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Clinical Trials/NCT06012396
NCT06012396
Recruiting
N/A

Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients

Pusan National University Yangsan Hospital1 site in 1 country126 target enrollmentMarch 6, 2023
ConditionsStrokeExercise

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Pusan National University Yangsan Hospital
Enrollment
126
Locations
1
Primary Endpoint
6WMT
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

A lot of physical and social effects of exercise programs and daily physical education have already been proven for stroke patients after discharge. However, stroke patients have shown a passive attitude in participating in physical education or exercise programs for life, and the local community lacked appropriate guidelines or experience in guiding exercise and physical education for stroke patients, so they had a burden on instructing exercise. In this study, an appropriate complex exercise program was established for patients after discharge through analysis of domestic and foreign research data to provide an environment and opportunity to exercise in the community, and based on the results, stroke patients actively exercise in the community in the future. The goal is to provide a basis for doing so.

Registry
clinicaltrials.gov
Start Date
March 6, 2023
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sung-Hwa Ko

Professor

Pusan National University Yangsan Hospital

Eligibility Criteria

Inclusion Criteria

  • Stroke patients aged 30 years or older residing in the community
  • Those who can walk independently and have a score of 3 or higher in the Functional Ambulation Category (FAC)
  • The daily life dependence of the stroke patient is a person who can perform simple tasks necessary for daily life, Those who scored 2 points or less on the Modified Rankin Scale (mRS)
  • Subjects with no or mild stiffness of the affected upper and lower limbs, with a score of 1 or less on the Modified Ashworth Scale (MAS)
  • All 3 major joints of the affected upper and lower limbs (Manual Muscle Test (MMT)) are 3 points (F grade) or higher ruler

Exclusion Criteria

  • With moderate or severe cognitive dysfunction, Korean-Mini Mental state test (Korean-Mini Mental state test) Those who scored less than 18 points in the Examination (K-MMSE)
  • A person with a moderate or higher fall risk and less than 41 points on the Berg Balance Scale (BBS)
  • Those who have difficulty understanding the intervention exercise program or expressing symptoms due to severe language impairment
  • Those who cannot apply this intervention exercise program due to serious cardiovascular disease
  • Those who have musculoskeletal disorders that make it impossible to exercise
  • Those who are judged unsuitable for this study under the judgment of a specialist in rehabilitation medicine due to other diseases

Outcomes

Primary Outcomes

6WMT

Time Frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians

Secondary Outcomes

  • MRS(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • FAC(visit 1, visit 23)
  • BBS(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • GDS(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • sit to stand(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • TUG(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • Grip Strength(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • Body composition(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • EQ-5D(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • flexibility test(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • MMT(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • Physical activity(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))
  • coordination test(Baseline and Follow-up evaluation (through study completion, an average of 6 weeks))

Study Sites (1)

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