Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02938416
Other study ID # CF12251
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date December 2024

Study information

Verified date November 2023
Source Taichung Veterans General Hospital
Contact Yuan-Yang Cheng, MD, PhD
Phone +886-4-23592525
Email rifampin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our participants will include 40 patients within one month of stroke, 43 patients who received total hip replacement or total knee replacement two to four weeks before. The participants will be randomly assigned to isokinetic, isotonic or isometric training groups. Outcome measures including isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma concentration of hsCRP, and the level of substance P in saliva will be collected at the beginning and 4 weeks after the training program. Statistical significant differences will be determined between the improvement of outcome measures of the isokinetic and the isotonic training groups.


Description:

Our participants will include 40 patients within one month of stroke, 43 patients who received total hip replacement or total knee replacement two to four weeks before. The participants will be randomly assigned to isokinetic, isotonic or isometric training groups. Outcome measures including isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma concentration of hsCRP, and the level of substance P in saliva will be collected at the beginning and 4 weeks after the training program. Statistical significant differences will be determined between the


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - within one month of acute stroke - receive total hip/knee replacement within two to four weeks before Exclusion Criteria: - cannot perform from sitting to standing - Body Mass Index > 30 - Lower limbs fracture history - Diabetic polyneuropathy - Cardiopulmonary diseases that impede exercise prescription - Impaired cognitive function - Infectious disease during the study period that may cause cytokine changes

Study Design


Intervention

Device:
Isokinetic strengthening exercise
Isokinetic strengthening exercise provides muscle training throughout the range of motion of a joint at a pre-set constant speed of angular velocity. It can be performed in an eccentric or concentric way in a controlled manner, and is evidenced to be an effective and safe training method in patients with anterior cruciate ligament reconstruction, burn injury, ankle instability, osteoarthritic knee, and chronic stroke in the past literatures.
Isotonic strengthening exercise
Isotonic strengthening exercise keeps the tension remained unchanged during the muscle's length changing. As the muscle's force changes via the length-tension relationship during a contraction, an isotonic contraction will keep force constant while velocity changes. There are two types of isotonic contractions: (1) concentric and (2) eccentric. In a concentric contraction, the muscle tension rises to meet the resistance, then remains the same as the muscle shortens. In eccentric, the muscle lengthens due to the resistance being greater than the force the muscle is producing.
Behavioral:
isometric strengthening exercise
home exercise education on isometric quadriceps strengthening on the day of out-patient appointment

Locations

Country Name City State
Taiwan Department of Physical Medicine and Rehabilitation Taichung City

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak torque Isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s 4 weeks
Secondary Timed Up and Go test stand up from a chair, walk for 3 meters and go back and sit down 4 weeks
Secondary Short Form 36 (SF-36) questionnaire Use the 36-item, patient-reported questionnaire to survey the self-perceived health status 4 weeks
Secondary Oxford Hip/Knee Score symptoms score during daily activities 4 weeks
Secondary The plasma concentration of hsCRP, and the level of substance P in saliva check by drawing blood and test 4 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A