Stroke, AcuteNCT06010940
Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients
A study testing Dietary supplement and Physical therapy in people with Stroke, Acute and Dysphagia, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients Read more about this study
- Who is it for?
- Ages 49 to 65 years
- Conditions the study is for
- Stroke, Acute, Dysphagia, Pneumonia
- What is being tested?
- Dietary supplement and Physical therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2020to 30 Nov 2023
- 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 49 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were diagnosed of stroke dysphagia by a neurologist.
- Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16).
- Patients' age ranged from 49 to 65 years old.
- Patients had the ability to understand and follow instructions.
- Patients were able to sit in upright position.
Who cannot join
- History of previous stroke.
- History of any swallowing problem.
- History of any disease, head and neck surgery or tumor that causes swallowing dysfunction.
- Any lung disease or pneumonia on admission.
- Patients with cognitive deficits or disturbed conscious level.
- Patients on mechanical ventilator.
- Patients with sensory or global aphasia.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients
Read the detailed description
Seventy acute ischemic cerebrovascular stroke patients suffering from dysphagia were selected from the stroke unit in El-Kasr EL Ainy Hospital. Their ages ranged from 49 -65 years. Stroke dysphagia was diagnosed by a neurologist. Gugging swallowing screen and A2DS2 score was used to assess risk of developing pneumonia. Stroke associated pneumonia was diagnosed by: Recommended Diagnostic Criteria for Definite and Probable SAP in Patients Not Receiving Mechanical Ventilation Based on the CDC Criteria. The selected patients were randomly assigned into two equal groups control group (A) and study group (B). Control group (A) was treated by nasogastric tube and oral care. Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. Assessment was done before treatment, at the middle and at the end of treatment for each patient. Treatment was conducted for five sessions per week for one month.
- Conditions
- Stroke, Acute, Dysphagia, Pneumonia
- Being tested
- Dietary supplement, Physical therapy
- Medical subject headings
- Stroke, Deglutition Disorders, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
nasogastric tube and oral care
Physical therapyOther
Designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control group (A) was treated by nasogastric tube and oral care. Receives: Dietary Supplement: Dietary supplement |
| study group | Experimental | Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. Receives: Dietary Supplement: Dietary supplement; Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gugging swallowing screen test score
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
Measured: at baseline
The Gugging swallowing screen test score
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
Measured: At middle of intervention (after two weeks)
The Gugging swallowing screen test score
est used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
Measured: post intervention (after one month)
Secondary outcomes (3)
Incidence of participant with stroke associated pneumonia
Measuring number and percentage of participants with stroke associated pneumonia in each group
Measured: at baseline
Incidence of participant with stroke associated pneumonia
Measuring number and percentage of participants with stroke associated pneumonia in each group
Measured: At middle of intervention (after two weeks)
Incidence of participant with stroke associated pneumonia
Measuring number and percentage of participants with stroke associated pneumonia in each group
Measured: post intervention (after one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start11 Oct 2020
- Primary completion26 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed khalifa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010940
- Sponsor's protocol ID
- P.T.REC/012/002939
- Status last verified
- May 2024
- First submitted
- 17 Aug 2023
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
PubMed 34746431Lo YK, Fu TC, Chen CP, Yuan SS, Hsu CC. Involvement of swallowing therapy is associated with improved long-term survival in patients with post-stroke dysphagia. Eur J Phys Rehabil Med. 2019 Dec;55(6):728-734. doi: 10.23736/S1973-9087.19.05893-3.
PubMed 31958220
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06010940
- Acronym / sponsor ID
- P.T.REC/012/002939
- Conditions
- Stroke, Acute, Dysphagia, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Aug 2023 (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.
To investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients
Detailed description
Seventy acute ischemic cerebrovascular stroke patients suffering from dysphagia were selected from the stroke unit in El-Kasr EL Ainy Hospital. Their ages ranged from 49 -65 years. Stroke dysphagia was diagnosed by a neurologist. Gugging swallowing screen and A2DS2 score was used to assess risk of developing pneumonia. Stroke associated pneumonia was diagnosed by: Recommended Diagnostic Criteria for Definite and Probable SAP in Patients Not Receiving Mechanical Ventilation Based on the CDC Criteria. The selected patients were randomly assigned into two equal groups control group (A) and study group (B). Control group (A) was treated by nasogastric tube and oral care. Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. Assessment was done before treatment, at the middle and at the end of treatment for each patient. Treatment was conducted for five sessions per week for one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Dietary Supplement: Dietary supplementControl group (A) was treated by nasogastric tube and oral care. |
| study group | Experimental | Dietary Supplement: Dietary supplement, Other: Physical therapyStudy group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. |
Who may qualify
- Ages
- 49 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients were diagnosed of stroke dysphagia by a neurologist.
- Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16).
- Patients' age ranged from 49 to 65 years old.
- Patients had the ability to understand and follow instructions.
- Patients were able to sit in upright position.
Key exclusion criteria (7 listed)
- History of previous stroke.
- History of any swallowing problem.
- History of any disease, head and neck surgery or tumor that causes swallowing dysfunction.
- Any lung disease or pneumonia on admission.
- Patients with cognitive deficits or disturbed conscious level.
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 |
|---|---|---|
| Dietary supplementnasogastric tube and oral care | Dietary supplement | control group, study group |
| Physical therapyDesigned physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. | Other | study group |
Primary outcome
The Gugging swallowing screen test score
Time frame: at baseline
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
The Gugging swallowing screen test score
Time frame: At middle of intervention (after two weeks)
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
The Gugging swallowing screen test score
Time frame: post intervention (after one month)
est used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
3 secondary outcomes
Incidence of participant with stroke associated pneumonia
Time frame: at baseline
Incidence of participant with stroke associated pneumonia
Time frame: At middle of intervention (after two weeks)
Incidence of participant with stroke associated pneumonia
Time frame: post intervention (after one month)
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 7 May 2024.
- Background: PubMed 34746431Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
- Background: PubMed 31958220Lo YK, Fu TC, Chen CP, Yuan SS, Hsu CC. Involvement of swallowing therapy is associated with improved long-term survival in patients with post-stroke dysphagia. Eur J Phys Rehabil Med. 2019 Dec;55(6):728-734. doi: 10.23736/S1973-9087.19.05893-3.
- 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 Dietary supplement and Physical therapy in people with Stroke, Acute and Dysphagia, run by Cairo University at 1 site in Egypt.
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 7 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 7 May 2024. 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 Egypt. 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?
The Gugging swallowing screen test score (time frame: at baseline). 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?
On the ClinicalTrials.gov record for NCT06010940, which also lists 2 linked publications.
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 7 May 2024.