Stroke, AcuteNCT04792619
The Effect of Scapular Exercises in Patients With Stroke
A study testing Bobath Approach and Isometric scapular exercises in people with Stroke, Acute, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
There is a paucity of research on the correlation between postural control and upper extremity function. Analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Bobath Approach and Isometric scapular exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2018to 31 Dec 2020
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as acute stroke, being able to sit without support, presence of hemiparesis, clinical stability
Who cannot join
- Shoulder joint dysfunction due to previous musculoskeletal disease, severe dementia, severe visual disturbances that could not be corrected with glasses, severe aphasia, scored ≥ 3 on the Modified Ashworth Scale and refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Scapular Exercises on Trunk Control in Patients With Stroke: A Double-blind Randomized Study
There is a paucity of research on the correlation between postural control and upper extremity function. Analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke.
The purpose of this study was to examine the effect of scapular exercises on the scapular stability and trunk control. We hypothesized that scapular exercises correct the scapular position and improve postural control. Hence the reaching out movement can be applied in a controlled and fluent manner at the end of the treatment.
- Conditions
- Stroke, Acute
- Being tested
- Bobath Approach, Isometric scapular exercises
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath ApproachOther
The patients in both groups were treated with the exercise program according to the Bobath concept was planned taking the functional needs of the survivors into account, including stretching and facilitation of latissimus dorsi muscle, facilitation of abdominal muscles, placing exercises, training of lumbar spine stabilizers, functional reach of shoulder in different directions. Five sessions of about an hour each were provided to the patients
Isometric scapular exercisesOther
Isometric scapular exercises were performed to the patients included to the study group in a sitting position and at 900 of the shoulder flexion and 900 of the shoulder abduction. The patients were exercised by a physiotherapist using isometric contraction in protraction and retraction by a physiotherapist. Isometric contractions lasted 5 seconds and each exercise was repeated 2x15 times. One minute rest period was given between sets
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Other: Bobath Approach |
| Study | Active comparator | Not described Receives: Other: Bobath Approach; Other: Isometric scapular exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapular mobility
Distance between medial border of scapula and columna vertebralis
Measured: 12 months
Trunk Impairment Scale
postural control ability of the trunk
Measured: 12 months
Trunk Control Test
Trunk Control
Measured: 12 months
Modified Barthel Index
evaluate the level of disability during daily life activities
Measured: 12 months
Reaching Performance Test
Reaching Performance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start3 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Duray, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792619
- Sponsor's protocol ID
- 60116787-020/81392
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scapular Exercises on Trunk Control in Patients With Stroke: A Double-blind Randomized Study
- ClinicalTrials.gov ID
- NCT04792619
- Acronym / sponsor ID
- 60116787-020/81392
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Mar 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.
There is a paucity of research on the correlation between postural control and upper extremity function. Analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke.
The purpose of this study was to examine the effect of scapular exercises on the scapular stability and trunk control. We hypothesized that scapular exercises correct the scapular position and improve postural control. Hence the reaching out movement can be applied in a controlled and fluent manner at the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Bobath Approach |
| Study | Active comparator | Other: Bobath Approach, Other: Isometric scapular exercises |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed as acute stroke, being able to sit without support, presence of hemiparesis, clinical stability
Key exclusion criteria (1 listed)
- Shoulder joint dysfunction due to previous musculoskeletal disease, severe dementia, severe visual disturbances that could not be corrected with glasses, severe aphasia, scored ≥ 3 on the Modified Ashworth Scale and refused to participate
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 |
|---|---|---|
| Bobath ApproachThe patients in both groups were treated with the exercise program according to the Bobath concept was planned taking the functional needs of the survivors into account, including stretching and facilitation of latissimus dorsi muscle, facilitation of abdominal muscles, placing exercises, training of lumbar spine stabilizers, functional reach of shoulder in different directions. Five sessions of about an hour each were provided to the patients | Other | Control, Study |
| Isometric scapular exercisesIsometric scapular exercises were performed to the patients included to the study group in a sitting position and at 900 of the shoulder flexion and 900 of the shoulder abduction. The patients were exercised by a physiotherapist using isometric contraction in protraction and retraction by a physiotherapist. Isometric contractions lasted 5 seconds and each exercise was repeated 2x15 times. One minute rest period was given between sets | Other | Study |
Primary outcome
Scapular mobility
Time frame: 12 months
Distance between medial border of scapula and columna vertebralis
Trunk Impairment Scale
Time frame: 12 months
postural control ability of the trunk
Trunk Control Test
Time frame: 12 months
Trunk Control
Modified Barthel Index
Time frame: 12 months
evaluate the level of disability during daily life activities
Reaching Performance Test
Time frame: 12 months
Reaching Performance
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 11 Mar 2021.
- Individual participant dataSharing planned: No
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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 Bobath Approach and Isometric scapular exercises in people with Stroke, Acute, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 11 Mar 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 Turkey (Türkiye). 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?
Scapular mobility (time frame: 12 months). The study lists 5 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 11 Mar 2021.