Clinical trial NCT05187559: Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Ischemia
Stroke, Ischemic
Keywords: Brain Ischemia
Stroke
Balance
Gait
Physiotherapy
Physical Therapy
Visual Feedback
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 120
Sex: ALL
Minimum age (years): 44
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups, 60 patients per group. Patients will be randomly assigned to first of second study group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle strength by Oxford scale
timeFrame: Baseline
measure: Gait and Balance testing by Berg Scale
timeFrame: Baseline
measure: Timed Stand Up and Go Test
timeFrame: Baseline
measure: Recovery Locus of Control Scale
timeFrame: Baseline
Secondary outcomes:
measure: Limits of Stability Testing with Biodex SD (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Risk of Fall Testing with Biodex SD (score)
timeFrame: Baseline - before enrolling 4 week training program and after the whole training
measure: Stance analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Gait analysis with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
measure: Center of Pressure analysis during step cycles with zebris FDM (score)
timeFrame: Baseline - before enrolling 4 week training program and after 4 week training
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Toma Steponkienė
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Eglė Lendraitienė, PhD
role: PRINCIPAL_INVESTIGATOR
References: