Stroke
Conditions
Keywords
Eccentric exercise, Stroke, Physical function, Muscle function
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.
Interventions
OTHERusual care and exercise education
Provide exercise training materials after the education of exercise and health to enable home-based exercise
OTHEREccentric exercise
Under the face-to-face supervisor, the eccentric exercise using a flywheel, and the self-directed home-based eccentric overload exercise using an elastic band are performed.
Sponsors
National Rehabilitation Center, Seoul, Korea
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isokinetic knee extensor strength | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Isometric knee strength | Change from Baseline physical function at 8 weeks of intervention | Evaluation of change from baseline isometric knee strength to 8 weeks after the initial assessment. Isometric knee strength was measured in Newton-meters (Nm) using a baltimore therapeutic equipment (BTE) Primus RS (BTE Tech., Hanover, MD, USA). The participants were asked to sit on the treatment chair and a standard stabilization strap was placed on the upper ankle. The knee was kept at 90 degree flexion, and the foot was positioned in dorsi-flexion. |
| Hand grip strength | Change from Baseline physical function at 8 weeks of intervention | Evaluation of change from baseline hand grip strength to 8 weeks after the initial assessment. Participants are tested while they were seated, their arms are against their sides, their elbows are flexed 90 degrees. Hand grip strength is measured in kilograms (kg) using a hand-grip dynamometer (Takei 5401, Tokyo, Japan). The maximum value from either hand is used for analysis. |
| Timed up and go | Change from Baseline physical function at 8 weeks of intervention. | Evaluation of change from baseline timed up and go to 8 weeks after the initial assessment. Participants sat on a chair and measured the time (second) that it took the participants to stand up, walk 3 m as quickly and safely as possible, turn around at a marked line on the floor, walk back, and sit down. |
| Isokinetic knee extensor eccentric strength | Change from Baseline muscle function at 8 weeks of intervention. | Evaluation of change from baseline isokinetic knee extensor eccentric strength to 8 weeks after the initial assessment. Isokinetic knee extensor eccentric strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 30° per second. |
| Isotonic knee power | Change from Baseline physical function at 8 weeks of intervention | Evaluation of change from baseline isotonic knee power to 8 weeks after the initial assessment. knee extension and flexion were performed as quickly as possible during a period of 10 seconds and is measured in watts. |
Countries
South Korea
Contacts
Primary ContactJae-Young Lim, M.D., Ph.D.
Backup ContactSeung-Lyul Oh, Ph.D.
Outcome results
None listed