Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Patients rehabilitated in Neurorabilitation Departmen of Lithuanian University of Health sciences hospital Kauno Kliniko in the second stage of rehabilitation;
- Stroke for the first time;
- 45-74 m. age;
- Able to go with aids;
- Voluntary consent to participate in the study.
Sites / Locations
- Lithuanian University of Health Sciences, Department of Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Intervention group (n=10) received differential learning based physiotherapy program: 3 times a week ordinary physiotherapy, 2 times a week differential learning based on physiotherapy, total 3 weeks
Control group (n=10) received ordinary physiotherapy program 5 times a week, total 3 weeks
Outcomes
Primary Outcome Measures
Torso control assessment scale
The torso control rating scale evaluates torso functions in a variety of locations, whether standing, sitting or performing a mobility assessment task. Each task was scored from 0 to 3 points: 0 - cannot perform task, 3 - can perfom task independently. Total test score is 36 and a higher total score meant a better trunk function.
Berg balance test
The Berg scale is used to assess a subject's static and dynamic balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. The maximum obtainable score is 56. 0 points -are awarded to answers portraying the lowest level of function while 4 points are awarded to the highest level of function.
Dynamic gait index is used to assess the likelihood of falling. A four-point ordinal scale, ranging from 0-3 points. Total maximum score is 24 points. 0 points indicates the lowest level of function and 3 points - the highest level of function.
Dynamic gait index assessed the gait model, provided information about the person's balance while walking
Secondary Outcome Measures
Full Information
NCT ID
NCT04985162
First Posted
July 26, 2021
Last Updated
August 9, 2021
Sponsor
Lithuanian University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04985162
Brief Title
Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Official Title
Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to assess the effect or ordinary and differential learning based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the second phase of rehabilitation
Detailed Description
Ischemic stroke is still the second most common cause of death and one of the leading causes of disability worldwide. Half of all individuals with ischemic stroke do not regain lost body functions until the end of life. Individuals with ischemic stroke are most likely to have impaired cognitive, sensory, and motor functions, but the greatest challenge for health care professionals is impaired motor skills caused by motor nerve cell damage. In order to minimize the degree of disability, it is important to respond quickly to a person's condition. Because it has been shown that lost functions can be taken over by adjacent, non-stroke-affected areas of the cerebral cortex, early rehabilitation is a key factor that can help prevent function limitation by acting in conjunction with spontaneous recovery of body function.
The aim of the study is to assess the effect or ordinary and differential learning based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the second phase of rehabilitation.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-KN(B)-263).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants were divided into intervention group and control group.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group (n=10) received differential learning based physiotherapy program: 3 times a week ordinary physiotherapy, 2 times a week differential learning based on physiotherapy, total 3 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group (n=10) received ordinary physiotherapy program 5 times a week, total 3 weeks
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
Differential learning based physiotherapy to improve torso control, balance and gait
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Ordinary physiotherapy program
Primary Outcome Measure Information:
Title
Torso control assessment scale
Description
The torso control rating scale evaluates torso functions in a variety of locations, whether standing, sitting or performing a mobility assessment task. Each task was scored from 0 to 3 points: 0 - cannot perform task, 3 - can perfom task independently. Total test score is 36 and a higher total score meant a better trunk function.
Time Frame
Baseline to 3 weeks
Title
Berg balance test
Description
The Berg scale is used to assess a subject's static and dynamic balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. The maximum obtainable score is 56. 0 points -are awarded to answers portraying the lowest level of function while 4 points are awarded to the highest level of function.
Time Frame
Baseline to 3 weeks
Title
Dynamic gait index is used to assess the likelihood of falling. A four-point ordinal scale, ranging from 0-3 points. Total maximum score is 24 points. 0 points indicates the lowest level of function and 3 points - the highest level of function.
Description
Dynamic gait index assessed the gait model, provided information about the person's balance while walking
Time Frame
Baseline to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients rehabilitated in Neurorabilitation Departmen of Lithuanian University of Health sciences hospital Kauno Kliniko in the second stage of rehabilitation;
Stroke for the first time;
45-74 m. age;
Able to go with aids;
Voluntary consent to participate in the study.
Facility Information:
Facility Name
Lithuanian University of Health Sciences, Department of Rehabilitation
City
Kaunas
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
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