Stroke, AcuteNCT03499574
Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke
A study testing Dysphagia therapy using surface EMG as biofeedback in people with Stroke, Acute and Dysphagia, Oropharyngeal, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Dysphagia, Oropharyngeal
- What is being tested?
- Dysphagia therapy using surface EMG as biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2018to 31 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis stroke, new dysphagia, medically stable, adequate trunk strength for videofluoroscopy.
Who cannot join
- Severe cognitive impairment, previous dysphagia, previous neurological condition, severe visual impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke
This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. The results will inform future dosing and efficacy studies.
- Conditions
- Stroke, Acute, Dysphagia, Oropharyngeal
- Being tested
- Dysphagia therapy using surface EMG as biofeedback, Usual Care
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysphagia therapy using surface EMG as biofeedbackBehavioural
Also called Biofeedback
10 x 45 minute sessions over 14 days
Usual CareBehavioural
Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback group | Experimental | Dysphagia therapy using surface EMG as biofeedback - 10 x 45 minute sessions of swallow strength and skill training using surface electromyography as biofeedback tool. This group will also receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education. Receives: Behavioral: Dysphagia therapy using surface EMG as biofeedback; Behavioral: Usual Care |
| Control group | Other | This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Count of number of participants can be recruited
Measured: 2 weeks
Number of participants completing the treatment
Count of number of participants completing the treatment
Measured: 2 weeks
Average number of sessions completed
Average number of sessions completed across participants.
Measured: 2 weeks
Secondary outcomes (10)
Change in Swallow function - severity
Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe.
Measured: Pre and post 3 week intervention intervention and at 90 days
Change in Swallow function - intake
Functional Oral Intake Scale - 7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.
Measured: Pre and post 3 week intervention intervention and at 90 days
Change in Swallow physiology - PAS
Videofluoroscopy assessment to measure swallow safety with regards to penetration/aspiration using the Penetration Aspiration Scale (PAS). 8 point scale. The higher the number the increase in penetration/aspiration.
Measured: Pre and post 2 week intervention
Change in swallow physiology - timing
Videofluoroscopy assessment to measure timing of swallow physiology
Measured: Pre and post 2 week intervention
Quality of life
Dysphagia Handicap Index
Measured: Pre and post 2 week intervention and at 90 days
Change in Clinical outcomes - disability
Disability - using the Modified Rankin scale. Scale from 0-6 with higher numbers signifying increased disability
Measured: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - stroke severity
Stroke severity - NIHSS. Scale from 0-42. Increased number means increase in stroke severity.
Measured: Pre and post 2 week intervention
Change in Clinical outcomes - tube status
Feeding tube status
Measured: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - mortality
Mortality
Measured: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - pneumonia
Presence of pneumonia
Measured: Pre and post 2 week intervention and at 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start26 Jan 2018
- Primary completion31 Mar 2020
- Study completion31 May 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
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Timothy England, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499574
- Sponsor's protocol ID
- 17028
- Status last verified
- Oct 2020
- First submitted
- 29 Nov 2017
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT03499574
- Acronym / sponsor ID
- 17028
- Conditions
- Stroke, Acute, Dysphagia, Oropharyngeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 17 Apr 2018 (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.
This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. The results will inform future dosing and efficacy studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Biofeedback group | Experimental | Behavioral: Dysphagia therapy using surface EMG as biofeedback, Behavioral: Usual CareDysphagia therapy using surface EMG as biofeedback - 10 x 45 minute sessions of swallow strength and skill training using surface electromyography as biofeedback tool. This group will also receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education. |
| Control group | Other | Behavioral: Usual CareThis group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New diagnosis stroke, new dysphagia, medically stable, adequate trunk strength for videofluoroscopy.
Key exclusion criteria (1 listed)
- Severe cognitive impairment, previous dysphagia, previous neurological condition, severe visual impairment
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 |
|---|---|---|
| Dysphagia therapy using surface EMG as biofeedbackAlso: Biofeedback10 x 45 minute sessions over 14 days | Behavioural | Biofeedback group |
| Usual CareUsual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary. | Behavioural | Biofeedback group, Control group |
Primary outcome
Number of participants recruited
Time frame: 2 weeks
Count of number of participants can be recruited
Number of participants completing the treatment
Time frame: 2 weeks
Count of number of participants completing the treatment
Average number of sessions completed
Time frame: 2 weeks
Average number of sessions completed across participants.
10 secondary outcomes
Change in Swallow function - severity
Time frame: Pre and post 3 week intervention intervention and at 90 days
Change in Swallow function - intake
Time frame: Pre and post 3 week intervention intervention and at 90 days
Change in Swallow physiology - PAS
Time frame: Pre and post 2 week intervention
Change in swallow physiology - timing
Time frame: Pre and post 2 week intervention
Quality of life
Time frame: Pre and post 2 week intervention and at 90 days
Change in Clinical outcomes - disability
Time frame: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - stroke severity
Time frame: Pre and post 2 week intervention
Change in Clinical outcomes - tube status
Time frame: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - mortality
Time frame: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - pneumonia
Time frame: Pre and post 2 week intervention and at 90 days.
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 29 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
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.
Timothy England, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dysphagia therapy using surface EMG as biofeedback in people with Stroke, Acute and Dysphagia, Oropharyngeal, run by University of Nottingham at 1 site in United Kingdom.
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 29 Oct 2020. 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 United Kingdom. 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?
Number of participants recruited (time frame: 2 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 29 Oct 2020.