- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06748378
Gait Parameters After Using the Tilt-table Exercise and Motor Imagery.
Analysis of Gait Parameters After Therapy Using the Tilt-table Exercise and Motor Imagery - a Randomized Observational Study on Stroke Patients.
Study Overview
Status
Conditions
Detailed Description
Sixty-six stroke patients were randomly assigned to three groups (conventional, with the addition of the Erigo®Pro table, and enriched with motor imagery). The Trunk Stability Test, walking speed, step symmetry, and lower limb load symmetry on the Riablo device, as well as the superficial tension of the transverse abdominis and multifidus muscles, were assessed before and after completing therapy.
Results: In each of the groups studied, the therapies used significantly improved the functional assessment of trunk stability (Trunk Control Test <0.001)). Additionally, after the intervention, the Erigo group showed a greater gait speed (p=0.003), while the Visualization group exhibited a higher level of tension in the multifidus (p=0.011) and transverse abdominal muscles (p=0.002).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Masovian District
-
Warsaw, Masovian District, Poland, 04-141
- Military Institute of Medicine National Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conventional rehabilitation
In conventional rehabilitation, patients performed daily physiotherapy, which included intensive preparatory training for standing and sitting positions, strengthening exercises, weight-bearing exercises, and balance and coordination exercises (from 40 to 60 minutes of therapy). Interventions: Procedure: Conventional rehabilitation, the Erigo®Pro table, motor imagery |
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, and the Riablo device to measure gate parameters.
Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.
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, and the Riablo device to measure the gate parameters.
Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.
|
|
Experimental: Erigo®Pro
Interventions: Effective therapy included 1 session on a tilting table at an angle of 42° for 20 minutes, 5 times a week (Monday to Friday) at a speed of 32 steps per minute, followed by a physiotherapy session for two weeks. Interventions: Procedure: Conventional rehabilitation, the Erigo®Pro table, motor imagery |
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, and the Riablo device to measure gate parameters.
Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.
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, and the Riablo device to measure the gate parameters.
Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.
|
|
Experimental: motor imagery (MI)
in addition to conventional physiotherapy, activity imagery during passive walking on the Erigo®Pro table was introduced. During the exercises on the table, the patients wore headphones that blocked out any external sounds, closed their eyes and their task was to imagine the sensation of their body moving (first-person imagination), differentiating the idea of walking in various real environments (park, forest, beach, snow, streets). in the city, walking at different speeds, going up and down stairs, running, etc.). Interventions: Procedure: Conventional rehabilitation, the Erigo®Pro table, motor imagery |
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, and the Riablo device to measure gate parameters.
Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.
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, and the Riablo device to measure the gate parameters.
Additionally, an evaluation of the superficial tension of the transverse abdominis and multifidus muscles was conducted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Control Test
Time Frame: two weeks
|
Assessment of trunk stability before and after therapy
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RiabloTM device
Time Frame: two weeks
|
Assessment of gate parameters before and after therapy
|
two weeks
|
|
Luna EMG
Time Frame: two weeks
|
Assessment of the surface tension of the transverse abdominis muscle and the tension of the multifidus muscle
|
two weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11/KRN/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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