The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients.

Stroke Clinical Trial

Official title:

The Influence of Therapy Enriched With the Erigo®Pro Table and Motor Imagery on the Body Balance of Patients After Stroke - a Randomized Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06276075
• Other study ID #: 10/KRN/2020
• Status: Completed
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: September 10, 2023

Study information

• Verified date: February 2024
• Source: Military Institute od Medicine National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke.

Description:

DESIGN: randomized observational study. SETTING: A hospital Rehabilitation Department. POPULATION: Sixty-six post-stroke patients mean, 64.85 ± 18.62 years. METHODS: 66 stroke patients were randomly assigned to three groups (22 people each) with different therapies (conventional, with the addition of Erigo®Pro and enriched with motor imagery). The therapy duration was two weeks. Patients underwent assessment before and after completion of therapy. The study used the Trunk Stability Test, Berg Balance Scale to assess balance, as well as the Riablo device to measure static balance. Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years to 85 Years

Eligibility

Inclusion Criteria:

1) patients 6-8 weeks post-stroke, 2) aged 38-85 years, mean, 3) males and females, 4) walking with or without assistance (modified Rankin scale = 3), 5) with slight neurological deficits (NIHSS =7). Exclusion Criteria: 1) stroke up to six weeks after the episode, 2) epilepsy, 3) no possibility to sit and stand, 4) persistent deficit of speech and cognitive functions, lack of attention, 5) visual disturbances, 6) depression, 7) high or very low blood pressure, dizziness, malaise.

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Conventional rehabilitation, the Erigo®Pro table, motor imagery
66 stroke patients were randomly assigned to three groups (22 people each) with different therapy (conventional, with the addition of Erigo®Pro and enriched with motor imagery). The therapy duration was two weeks. Patients underwent assessment before and after completion of therapy. The study used the Trunk Stability Test, Berg Balance Scale to assess balance, as well as the Riablo device to measure static balance. Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw	Masovian District

Sponsors (1)

Lead Sponsor	Collaborator
Anna Olczak

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Control Test	Assessment of trunk stability before and after therapy	two weeks
Primary	Berg Balance Scale	Assessment of body balance before and after therapy	two weeks
Primary	RiabloTM device	Assessment of static balance in the frontal plane before and after therapy	two weeks
Primary	RiabloTM device	Assessment of static balance in the sagittal plane before and after therapy	two weeks
Primary	Luna EMG	Assessment of the surface tension of the transverse abdominis muscle	two weeks
Primary	Luna EMG	Assessment of the surface tension of the multifidus muscle	two weeks