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Completed

NCT Number: NCT02793362

Measurement of Sarcopenia at Post-stroke Rehabilitation Outcome

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon St. Mary's Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in K-MBI score from initial evaluation to the final evaluation

    Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

Secondary outcomes

  1. Change in Berg balance scale from initial evaluation to the final evaluation

    Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

  2. Change in Fatigue scale from initial evaluation to the final evaluation

    Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

  3. Change in Motricity index from initial evaluation to the final evaluation

    Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

  4. Change in Functional Oral Intake Scale (FOIS) from initial evaluation to the final evaluation

    Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

  5. Change in MMSE from initial evaluation to the final evaluation

    Time frame: 8 weeks, 12 weeks, 16 weeks from the first onset of the stroke

Sponsors and collaborators

Lead sponsor

Bucheon St. Mary's Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 8, 2016
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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