Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors

NCT05187559 | Unknown

• 1 other identifier: RK-NRB-TS-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Ischemia; Stroke, Ischemic

Keywords

Brain Ischemia; Stroke; Balance; Gait; Physiotherapy; Physical Therapy; Visual Feedback

Outcome Measures

Primary Outcomes (4)

• Muscle strength by Oxford scale

  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.

  Baseline

• Gait and Balance testing by Berg Scale

  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).

  Baseline

• Timed Stand Up and Go Test

  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.

  Baseline

• Recovery Locus of Control Scale

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

  Baseline

Secondary Outcomes (27)

• Limits of Stability Testing with Biodex SD (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

• Stance analysis with zebris FDM (score)

  Baseline - before enrolling 4 week training program and after 4 week training

• Gait analysis with zebris FDM (score)

  Baseline - before enrolling 4 week training program and after 4 week training

• Gait analysis with zebris FDM (score)

  Baseline - before enrolling 4 week training program and after 4 week training

Study Arms (2)

First Group

EXPERIMENTAL

Neuromuscular exercise program with standard physiotherapy with no visual feedback.

Other: Standard physiotherapy

Second Group

EXPERIMENTAL

Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform

Device: Biodex Balance SD and Biodex Gait Trainer

Interventions

Standard physiotherapy OTHER

Neuromuscular exercise program with standard physiotherapy with no visual feedback

First Group

Biodex Balance SD and Biodex Gait Trainer DEVICE

Neuromuscular exercise program with physiotherapy with visual feedback using Biodex platform

Second Group

Eligibility Criteria

• Age: 44 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Toma Steponkienė

Kaunas, 47484, Lithuania

RECRUITING

MeSH Terms

Conditions

Brain Ischemia; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Eglė Lendraitienė, PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toma Steponkienė

CONTACT

+37068375252; toma.steponkiene@lsmu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Lecturer

Model Details: Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 12, 2022
• Study Start: December 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)