Neurological Rehabilitation Clinical Trial
Official title:
Investigation of the Influence of the Body Composition of Neurological (Early) Rehabilitants as Well as Their Change in the Course of Rehabilitation and the Effect on Rehabilitation Success - a Pilot Study
NCT number | NCT04204655 |
Other study ID # | BIA-Studie |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 25, 2019 |
Est. completion date | May 1, 2024 |
An optimal nutritional supply is associated with better outcome and recovery. For investigating the influence of the nutritional status and body composition on the course of rehabilitation, bioelectrical impedance analyzes (BIA) should be carried out on neurological (early) rehabilitants during the rehabilitation process. Possible disturbances, suitable outcome valuesfor evaluation of the rehabilitation success (depending on the rehabilitation phase) as well as the required frequency of the BIA measurements in rehabilitation should be estimated with the help of this pilot study.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | May 1, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - neurological disease Exclusion Criteria: - electrical implant as cardiac pacemaker, medications pumps, defibrillators - pregnancy or breastfeeding period - take part on another study within the last 30 days - spasticity - amputation of limbs |
Country | Name | City | State |
---|---|---|---|
Germany | Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf | Hessisch Oldendorf | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
BDH-Klinik Hessisch Oldendorf |
Germany,
Elke G, Hartl WH, Kreymann KG, Adolph M, Felbinger TW, Graf T, de Heer G, Heller AR, Kampa U, Mayer K, Muhl E, Niemann B, Rumelin A, Steiner S, Stoppe C, Weimann A, Bischoff SC. [DGEM Guideline "Clinical Nutrition in Critical Care Medicine" - short versio — View Citation
Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776. — View Citation
Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin — View Citation
Schmidt SB, Boltzmann M, Krauss JK, Stangel M, Gutenbrunner C, Rollnik JD. Standardized nutritional supply versus individual nutritional assessment: Impact on weight changes, complications and functional outcome from neurological early rehabilitation. Cli — View Citation
Schmidt SB, Boltzmann M, Rollnik JD. Nutritional situation of enterally fed patients in neurological early rehabilitation and impact of nutritional status on functional outcome. Clin Nutr. 2020 Feb;39(2):425-432. doi: 10.1016/j.clnu.2019.02.011. Epub 2019 — View Citation
Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krahenbuhl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9 — View Citation
Stucki G, Cieza A, Geyh S, Battistella L, Lloyd J, Symmons D, Kostanjsek N, Schouten J. ICF Core Sets for rheumatoid arthritis. J Rehabil Med. 2004 Jul;(44 Suppl):87-93. doi: 10.1080/16501960410015470. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood Pressure | Blood pressure (mmHg) is measured before each BIA measurement. | 1 minute | |
Other | Pulse | Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement. | < 1 minute | |
Other | Saturation | Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement. | < 1 minute | |
Other | Body Height | Height is measured in a standing position with a measuring tape. In the case that the patient is not able to stand, the measurement is performed in a lying position. | 2 minutes | |
Other | Body weight | Weight (kg) is measured in the morning with clothes but without shoes. | 5 minutes | |
Other | Hip Circumference | Hip circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand). | 1 minute | |
Other | Waist Circumference | Waist circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand). | 1 minute | |
Other | Calf Circumference | Calf circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand). | 1 minute | |
Primary | Functional Status | The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation. | 3 minutes | |
Primary | Disabilities | An ICF-Assessment of 20 items is used for determination of disabilities of activities and body functions. The severity of each item is scored from zero ("no impairment") to four ("complete impairment") upon admission and at the end of rehabilitation. | 3 minutes | |
Primary | Muscle Strenght | The hand force is measured with a hand force dyometer three times on each hand upon admission and at the end of rehabilitation. | 3 minutes | |
Primary | Mobility | The mobility is assed by the Rivermead Mobility Index. | 4 minutes | |
Primary | Lenght Of Stay | duration of neurological rehabilitation (in days) | < 1 minute | |
Primary | Mortality | Number of deaths | < 1 minute | |
Primary | Discharge Level | Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital) | < 1 minute | |
Secondary | Bioelectrical Impedance | Bioelectrical Impedances for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. | 15 minutes | |
Secondary | Nutritional Risk Screening (NRS 2002) | Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002). | 5 minutes | |
Secondary | Mini Nutritional Assessment (MNA) | Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA). | 5 minutes |
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