Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

NCT02793362 | Completed DMC

• 1 other identifier: HC16OIS0028
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are

1. 1.To explore effect of sarcopenia on recovery of post stroke hemiplegia
2. 2.To explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function
3. 3.To quantify and qualify post stroke loss of muscle mass
4. 4.To validity the use of echointensity and elastography in evaluation of sarcopenia.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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 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

• Change in MMSE from initial evaluation to the final evaluation

  8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

Study Arms (5)

Normal subjects without stroke

1. subjects who can walk independent without any difficult 2. subjects without history of CNS or PNS lesion 3. Modified ranking scale (MRS) \<=2 4. Functional ambulation category (FAC) \>=2

Post stroke patients with sarcopenia(by sarcopenia index)

Existence of sarcopenia will be determined by DEXA scan where sarcopenia index of male less than 7.40 kg/m2, that of female less than 5. 14 kg/m2 are considered as sarcopenia.

Post stroke patients without sarcopenia(by sarcopenia index)

patients who do not satisfy the value of DEXA scan where sarcopenia index of male less than 7.40 kg/m2, that of female less than 5. 14 kg/m2 are considered as sarcopenia.

Post stroke patients with sarcopenia(by lean body mass)

Existence of sarcopenia will be determined by DEXA scan where appendicular lean mass less than \<19.75 kg in men, and \<15.02 kg in women are considered sarcopenia.

Post stroke patients without sarcopenia(by lean body mass)

patienst who do not satisfy the value of DEXA scan where appendicular lean mass less than \<19.75 kg in men, and \<15.02 kg in women are considered sarcopenia.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruited subjects will be allocated into 3 different groups. 1. Normal subjects without stroke (30 healthy volunteers) 2. Post stroke patients with sarcopenia (40 first ever stroke patients who admitted to Bucheon St. Mary's Hospital) 3. Post stroke patients without sarcopenia (40 first ever stroke patients who admitted to Bucheon St. Mary's Hospital)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Bucheon St. Mary's Hospital: lead

Study Sites (1)

Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Geun-Young Park

  Bucheon St. Mary's Hospital

  STUDY DIRECTOR

• Yongmin Choi

  Bucheon St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Sun Im

  Bucheon St. Mary's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: December 30, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

KR (1)