Reliability of Rehabilitative Ultrasound for the Quadriceps Muscle and Sarcopenia in Poststroke Patients

• Sponsor: Gaziosmanpasa Research and Education Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04042818
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia; Stroke, Complication; Quadriceps Muscle Atrophy; Hemiplegia; Ultrasonography; Hand Strength	Diagnostic Test: Rehabilitative Ultrasound

Detailed Description

Poststroke patients often suffer from muscle atrophy in quadriceps muscle. Quadriceps muscle is essential for independent standing or ambulation after stroke. Quadriceps muscle consists of four different muscles: rectus femoris, vastus intermedius, vastus lateralis and medialis. The present study search for reliability for rectus femoris and vastus intermedius muscle thickness and cross-sectional area using rehabilitative ultrasound imagining. Longitudinal and transverse ultrasound imagining of the muscle thickness will be performed on both rectus femoris and vastus intermedius muscles for both extremities. The procedures will be repeated by two experts at two separate times (7-10 days). For sarcopenia measurement grip strength and DEXA measurements of the patients will be calculated. Totally 68 patients will be included in the study.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 68 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Reliability of Rehabilitative Ultrasound Imaging for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
• Actual Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2019
• Anticipated Study Completion Date: Jan 30, 2020

Outcome Measures

Primary Outcome Measures

1. Thickness of Rectus Femoris Muscle [One week]

   Longitudinal and Transverse thickness of rectus femoris muscle

2. Thickness of vastus intermedius muscle [One week]

   Longitudinal and Transverse thickness of vastus intermedius muscle

3. Cross-sectional area of Rectus Femoris Muscle [One week]

   Cross-sectional area of Rectus Femoris Muscle

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Poststroke patients (>6 months)

Exclusion Criteria:

• < 6 months after stroke

• Multiple stroke

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpasa Taksim Training and Research Hospital	Istanbul		Turkey	34255

Sponsors and Collaborators

• Gaziosmanpasa Research and Education Hospital

Investigators

• Study Director: Ebru Y Yalçınkaya, M.D., Gaziosmanpasa Taksim Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Research and Education Hospital
• ClinicalTrials.gov Identifier: NCT04042818
• Other Study ID Numbers: GaziosmanpasaTREH7
• First Posted: Aug 2, 2019
• Last Update Posted: Aug 2, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Research and Education Hospital: Sarcopenia; Stroke; Quadriceps Muscle Atrophy; Hemiplegia; Ultrasonography; Hand Strength
• Additional relevant MeSH terms: Sarcopenia; Hemiplegia; Muscular Atrophy; Atrophy

Study Results

No Results Posted as of Aug 2, 2019