Ischemic StrokeNCT04985162
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
A study testing Intervention group in people with Ischemic Stroke, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2020to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences, Department of Rehabilitation
Kaunas
About this study
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
Read the 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).
- Conditions
- Ischemic Stroke
- Being tested
- Intervention group, Control group
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Differential learning based physiotherapy to improve torso control, balance and gait
Control groupOther
Ordinary physiotherapy program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: Intervention group |
| Control | Active comparator | Control group (n=10) received ordinary physiotherapy program 5 times a week, total 3 weeks Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 weeks
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.
Measured: Baseline to 3 weeks
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
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Sep 2020
- Primary completion8 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Smilgiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985162
- Sponsor's protocol ID
- 002
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04985162
- Acronym / sponsor ID
- 002
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intervention groupIntervention 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 | Active comparator | Other: Control groupControl group (n=10) received ordinary physiotherapy program 5 times a week, total 3 weeks |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupDifferential learning based physiotherapy to improve torso control, balance and gait | Other | Intervention |
| Control groupOrdinary physiotherapy program | Other | Control |
Primary outcome
Torso control assessment scale
Time frame: Baseline to 3 weeks
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
Time frame: Baseline to 3 weeks
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.
Time frame: Baseline to 3 weeks
Dynamic gait index assessed the gait model, provided information about the person's balance while walking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Ischemic Stroke, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Torso control assessment scale (time frame: Baseline to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.