Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

Completed

• Conditions: Sarcopenia

• Registration Number: NCT02793362
• Lead Sponsor: Bucheon St. Mary's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Primary Completion: 2017-05-30
• Study Completion: 2018-12-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-01
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Fatigue scale from initial evaluation to the final evaluation	8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in Motricity index from initial evaluation to the final evaluation	8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
Change in MMSE from initial evaluation to the final evaluation	8 weeks, 12 weeks, 16 weeks from the first onset of the stroke
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
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

Trial Locations

Locations (1)

Bucheon St. Mary's Hospital; 🇰🇷 Bucheon-si, Gyeonggi-do, Korea, Republic of