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Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injury

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

cryotherapy

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring muscle activation, ACL reconstruction, cryotherapy, TENS

Eligibility Criteria

20 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery.

Exclusion Criteria:

meniscus lesion, bony fracture and osteochondral lesions

Sites / Locations

National Taiwan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ice, rate of force development

Arm Description

to monitor the long term effect of cryotherapy in rate of force development.

Outcomes

Primary Outcome Measures

Muscle activation

To provide information of individual muscles for the correlation analyses, parameters of muscle activation, such as the integrated electromyography (EMG) normalized to the maximal M wave, are favored.

Secondary Outcome Measures

Full Information

NCT ID

NCT01273649

First Posted

January 6, 2011

Last Updated

May 27, 2014

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01273649

Brief Title

Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction

Official Title

Therapeutic Effects of Cryotherapy and Transcutaneous Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can effectively reduce the arthrogenic muscle inhibition caused by experimental swelling. Objective: To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in subjects with ACL reconstruction. Design: Prospective study. Subjects: Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery. Methods: Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and rate of force development are measure at presurgery, 3-month, 6-month after surgery. After surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes cryotherapy and exercise training with TENS. Data analysis: Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will be used to analysis data.

Detailed Description

Examination procedure: Skin preparation and EMG setting. Fill out knee joint function questionnaire. Warmup with a stationary bike. Single hop for distance. MVIC test and EMG recording. Endurance test. Record surface EMG of vastus lateralis, vastus medialis, biceps femoris and semitendinosus during maximal voluntary contraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injury

Keywords

muscle activation, ACL reconstruction, cryotherapy, TENS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ice, rate of force development

Arm Type

Experimental

Arm Description

to monitor the long term effect of cryotherapy in rate of force development.

Intervention Type

Device

Intervention Name(s)

cryotherapy

Intervention Description

cryotherapy is given with other physical training

Primary Outcome Measure Information:

Title

Muscle activation

Description

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery. Exclusion Criteria: meniscus lesion, bony fracture and osteochondral lesions

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

HK Wang, PhD

hkwang@ntu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HK Wang, PhD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

HK Wang, PhD

Phone

00886-02-33668134

hkwang@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction

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