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Clinical Trials/NCT05187559
NCT05187559RecruitingNot Applicable

Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position During Standing and Walking for Patients With Stroke During the Second Stage of Rehabilitation

Lithuanian University of Health Sciences1 site in 1 country120 target enrollmentStarted: December 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
1
Primary Endpoint
Recovery Locus of Control Scale

Study Overview

Brief Summary

The aim of the biomedical research is to evaluate the changes of body position management during standing and walking for stroke patients, using innovative training methods during the rehabilitation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
44 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Experienced an ischemic stroke for the first time;
  • •Middle-aged (44-59) and elderly (60-74) by WHO classification;
  • •Muscle strength of the lower extremities according to the Oxford scale is 3-5 points;
  • •Do not have any neglect;
  • •Mini Mental State Examination >12 points.

Exclusion Criteria

  • •Experienced an ischemic stroke not for the first time;
  • •Had hip or knee replacement surgery's, which may affect gait;
  • •Muscle strength of the lower extremities according to the Oxford scale is 0-2 points;
  • •Have neglect;
  • •Mini Mental State Examination <12 points.

Arms & Interventions

First Group

Experimental

Neuromuscular exercise program with standard physiotherapy with no visual feedback.

Intervention: Standard physiotherapy (Other)

Second Group

Experimental

Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform

Intervention: Biodex Balance SD and Biodex Gait Trainer (Device)

Outcomes

Primary Outcomes

Recovery Locus of Control Scale

Time Frame: Baseline

This scale contains 9 statements that are designed to evaluate the internal and external beliefs regarding the traumatic events that the patient has experienced.

Muscle strength by Oxford scale

Time Frame: Baseline

Testing key muscles from the lower and upper extremities against the examiner's resistance and grading the patient's strength on a 0 (No contraction) to 5 (Movement against gravity with full resistance) scale.

Gait and Balance testing by Berg Scale

Time Frame: Baseline

The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk).

Timed Stand Up and Go Test

Time Frame: Baseline

subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. 314. The test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change over time.

Secondary Outcomes

  • Gait analysis with zebris FDM (score)(Baseline - before enrolling 4 week training program and after 4 week training)
  • Center of Pressure analysis during step cycles with zebris FDM (score)(Baseline - before enrolling 4 week training program and after 4 week training)
  • Limits of Stability Testing with Biodex SD (score)(Baseline - before enrolling 4 week training program and after 4 week training)
  • Stance analysis with zebris FDM (score)(Baseline - before enrolling 4 week training program and after 4 week training)
  • Risk of Fall Testing with Biodex SD (score)(Baseline - before enrolling 4 week training program and after the whole training)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Toma Steponkienė

PhD student, Lecturer

Lithuanian University of Health Sciences

Study Sites (1)

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