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Clinical Trials/NCT04600050
NCT04600050
Unknown
N/A

Effect of Eccentric Contraction-based Resistance Exercise on Functional Recovery in Chronic Stroke Patients

Seoul National University Bundang Hospital1 site in 1 country40 target enrollmentAugust 11, 2020
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Seoul National University Bundang Hospital
Enrollment
40
Locations
1
Primary Endpoint
Isokinetic knee extensor strength
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to develop an evidence-based rehabilitation treatment method suitable for recovery and improvement of physical function in chronic stroke patients using an eccentric overload flywheel device. Participants are disabled with chronic stroke (ischemic and hemorrhagic cerebral hemorrhage) over 50 years of age, who can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher, and whose functional gait score is 3-5 points. The investigators will enroll 40 participants and randomly assign them to either the control (Con, n=20) or the exercise (Ex, n=20) group. The investigators will verify the effectiveness of the exercise program through the evaluation of changes in muscle and physical function before and after intervention in both groups.

Registry
clinicaltrials.gov
Start Date
August 11, 2020
End Date
January 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jae-Young Lim

Professor, Department of Rehabilitation Medicine

Seoul National University Bundang Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with disabilities 50 years of age or older who have been diagnosed with a stroke (ischemic and hemorrhagic cerebral hemorrhage) for at least one year
  • Patients can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher
  • Patients have a functional ambulation category (FAC) score of 3 to 5

Exclusion Criteria

  • Patients with brain lesions and quadriplegia excluding stroke
  • Patients with uncontrolled hypertension with limited exercise intervention
  • Patients diagnosed with angina
  • Patients with congestive heart failure (CHF)
  • Patients with upper/lower extremity fracture within 6 months

Outcomes

Primary Outcomes

Isokinetic knee extensor strength

Time Frame: Change from Baseline muscle function at 8 weeks of intervention.

Evaluation of change from baseline isokinetic knee extensor strength to 8 weeks after the initial assessment. Isokinetic knee extensor strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 60° per second.

Short physical performance battery (SPPB) scores

Time Frame: Change from Baseline physical function at 8 weeks of intervention.

Evaluation of change from baseline SPPB score to 8 weeks after the initial assessment. The SPPB is a group of measures that combine the results of the gait speed, timed chair stand and balance tests. For the static standing balance test, participants were asked to stand in side-by-side, semi-tandem and tandem positions, and maintain each position for 10 s. For the gait speed test, participants were asked to walk along a 4-m distance at their normal walking speed. For the repeated chair rise test, participants were asked to fold their arms across their chest and stand up from a sitting position five times consecutively as quickly as possible. Performance scores for each SPPB individual test and a summary score aggregating the individual tests were calculated as per standard SPPB protocol (range 0-12). The scores range from 0 (worst performance) to 12 (best performance).

Secondary Outcomes

  • Hand grip strength(Change from Baseline physical function at 8 weeks of intervention)
  • Isotonic knee power(Change from Baseline physical function at 8 weeks of intervention)
  • Isometric knee strength(Change from Baseline physical function at 8 weeks of intervention)
  • Timed up and go(Change from Baseline physical function at 8 weeks of intervention.)
  • Isokinetic knee extensor eccentric strength(Change from Baseline muscle function at 8 weeks of intervention.)

Study Sites (1)

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