Body Composition of People After a Stroke

NCT03722602 | Completed

• 1 other identifier: Stroke-BodyComposition
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study enabled assessment of changes in body mass composition, metabolic syndrome and lipid profile in patients after stroke, following rehabilitation in hospital.

Conditions

Rehabilitation; Stroke; Body Composition

Keywords

stroke; BMI; body composition; functional scales

Outcome Measures

Primary Outcomes (1)

• Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.

  Assessment of body composition (bioelectrical impedancy analysis - Tanita 780) Change from Baseline body composition at 5 weeks between baseline, after the end of protocol treatment, and 12 weeks after the end of the protocol treatment.

  at baseline, immediately after treatment completion, and 12 weeks after treatment completion

Secondary Outcomes (15)

• Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.

  at baseline, immediately after treatment completion, and 12 weeks after treatment completion

• Balance was assessed using Berg Balance Scale (BBS)

  at baseline, immediately after treatment completion, and 12 weeks after treatment completion

• Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.

  at baseline, immediately after treatment completion, and 12 weeks after treatment completion

• Assessment of paretic limb function was assessed using the Brunnström scale.

  at baseline, immediately after treatment completion, and 12 weeks after treatment completion

• Assessment of symmetry index for lower limb weight distribution

  at baseline, immediately after treatment completion, and 12 weeks after treatment completion

Study Arms (1)

Rehabilitation group

EXPERIMENTAL

Patients with stroke receiving standard inpatient rehabilitation for five weeks

Other: Standard rehabilitation after stroke

Interventions

Standard rehabilitation after stroke OTHER

The program of the rehabilitation was designed specifically for each patient. It was prepared to match the patient's functional status and the defined goals. The subjects participated in exercise five days per week, for five weeks. During their stay at the Clinic, the patients took part in morning exercise and received individual practice, based on neuro-developmental treatment (Bobath concept), and proprioceptive neuromuscular facilitation (PNF) method, addressing the impaired motor abilities; if it was needed they also performed exercise based on equipment using biological feedback: Balance Trainer (static and dynamic parapodium) and Pablo system designed for upper limb training.

Rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke experienced.
• Ability to stand without assistance.
• Ability to walk without aid.
• No impairments in higher mental functions
• Patient's informed, voluntary consent to participate in the study.

You may not qualify if:

• Lack of patient's consent to participate in the study
• Lack of ability to stand without assistance.
• Ischemic lesion located in the cerebellum and brain stem.
• Metal, electronic implants.
• Epilepsy.
• Pregnancy.
• Menstruation, in females.
• Limb injuries incurred following stroke onset, prior to the exam.

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-205, Poland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Justyna Leszczak, PhD

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: October 29, 2018
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

PL (1)