Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

Sarcopenia Clinical Trial

Official title:

Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793362
• Other study ID #: HC16OIS0028
• Status: Completed
• Start date: May 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2019
• Source: Bucheon St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purposes of this study are

1. To explore effect of sarcopenia on recovery of post stroke hemiplegia

2. To explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function

3. To quantify and qualify post stroke loss of muscle mass

4. To validity the use of echointensity and elastography in evaluation of sarcopenia.

By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke complications that is closely related to worth functional outcome, thereby emphasizing the importance of evaluation of sarcopenia as well as its prevention.

Description:

Sarcopenia occurs frequently among old population. The changes can rather occur earlier after trauma or generalized illness. However, the nature of these sarcopenia is different from that of geriatric population. Post stroke sarcopenia is underestimated however reduction in the motor uni number begins within 4 hours post stroke and after 3 weeks, sarcopenia can be seen in both hemiplegia and normal side. This muscular weakness can hinder functional recovery process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 30, 2018
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria for stroke patients

• First ever subacute stroke patients whose lesions were confirmed in brain imaging (MRI/CT)

• Patients who did not have difficulty in premorbid ambulation or activities of daily living.

• Patients who can follow 1 step obey

• Patients who can perform hand function test

• Patients whose laboratory tests, neurologic, cognitive, and dysphagia evaluations are completed within 1 month from the onset date.

• Patients who admitted/transferred into our department for at least 4 weeks, following conventional rehabilitation protocols.

• Patients with at least 2 of MRS(Modified Ranking Score) and FAC(Functional ambulation category) scores.

Exclusion Criteria: for stroke patients

• Patients who do not meet the above listed criteria

• Patients with double hemiplegia

• Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.

• Patients with joint contracture who are difficult to perform sonographic evaluation.

• Traumatic brain injury patients.

Inclusion Criteria for normal subjects

• Subjects who can walk independent without any difficult

• Subjects without history of CNS or PNS lesion

• MRS(Modified ranking scale) <=2

• FAC(functional ambulation category) >=2

Exclusion Criteria for normal subjects

• Patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (Example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, AIDS, malignancy, pregnancy, amputation, or operation.

Related Conditions & MeSH terms

• Sarcopenia

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St. Mary's Hospital	Bucheon-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Bucheon St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in K-MBI score from initial evaluation to the final evaluation		8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Secondary	Change in Berg balance scale from initial evaluation to the final evaluation		8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Secondary	Change in Fatigue scale from initial evaluation to the final evaluation		8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Secondary	Change in Motricity index from initial evaluation to the final evaluation		8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Secondary	Change in Functional Oral Intake Scale (FOIS) from initial evaluation to the final evaluation		8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Secondary	Change in MMSE from initial evaluation to the final evaluation		8 weeks, 12 weeks, 16 weeks from the first onset of the stroke