StrokeARCASNCT04795115
The ARCAS Study: Auditory Rhythmical Cueing for Gait in Acute Stroke
An observational study of Stroke, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Difficulties with walking is a common and distressing problem following stroke and can lead to reduced independence. Research suggests that using an auditory cue, such as a regular beat or pulse, as part of rehabilitation can improve walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Auditory rhythmical cueing
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2019to 8 Aug 2019
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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
Study population: Adults within 2 days to 3 weeks following acute stroke with residual mobility problems. They must be able to sit unsupported, stand with assistance of 1- 2 people and be able to comply with the intervention programme.
Who may be able to join
- Adults (> 18 years) following acute stroke (any subtype) with residual mobility problems
- Within 2 days - 4 weeks post-stroke.
- Be able to sit unsupported and stand with assistance of 1 or 2 people
- Able to provide informed consent to participate in the study.
Who cannot join
- Unable to follow the intervention due to cognitive or language impairment.
- Other medical problems affecting walking and balance (e.g. Parkinson's Disease, severe osteoarthritis and cardiopulmonary conditions).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Tyneside General Hospital
Newcastle upon Tyne, Tyne and Wear, NE29 8NH
About this study
Official title: Feasibility and Acceptability of an Auditory Rhythmical Cueing Intervention Targeting Balance and Gait in Early Rehabilitation (ARCAS)
Difficulties with walking is a common and distressing problem following stroke and can lead to reduced independence. Research suggests that using an auditory cue, such as a regular beat or pulse, as part of rehabilitation can improve walking. It is also recommended that early rehabilitation following stroke delivers the bestoutcome for patients.
Study aim:To determine whether the use of auditory cueing in early stroke rehabilitation is feasible during a balance and gait therapy programme.
Read more
Study participants: Adults following acute stroke with walking problems. Participants must be able to sit unsupported and stand with assistance of 1 or 2 people. They will be recruited from the acute stroke unit at North Tyneside General Hospital 2 days to 4 weeks following stroke. A total of 12 participants will be recruited.
Study setting: Acute stroke unit - North Tyneside General Hospital and participants homes if they are discharged within the study period.
Intervention:Participants will receive auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 / week for 3 weeks within the physiotherapy gym on the stroke unit or at home if discharged within the intervention period. The 30 minutes will consist of balance exercises and walking practice using auditory cueing with a metronome.
Measures:1. What the participants and the therapists think of the intervention will be assessed by questionnaires. The questionnaires contain open and closed questions and have been developed specifically for this study.
2.The stroke survivors trunk control, balance and walking will be assessed before and after the intervention.
Study Duration: 12 months
Future Plans: This study will be used to inform a larger study testing if the intervention works and how much it costs
- Conditions
- Stroke
- Being tested
- Auditory rhythmical cueing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory rhythmical cueingOther
Auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 per week for 3 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant questionnaire
To seek views of patients on the intervention programme
Measured: 3 weeks
Therapist questionnaire
To seek views from therapists on the intervention programme
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start4 Feb 2019
- Primary completion31 May 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795115
- Sponsor's protocol ID
- 0031
- Acronym
- ARCAS
- Status last verified
- Mar 2021
- First submitted
- 9 Jan 2019
- Last updated
- 12 Mar 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 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Auditory Rhythmical Cueing Intervention Targeting Balance and Gait in Early Rehabilitation (ARCAS)
- ClinicalTrials.gov ID
- NCT04795115
- Acronym / sponsor ID
- ARCAS / 0031
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 12 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.
Difficulties with walking is a common and distressing problem following stroke and can lead to reduced independence. Research suggests that using an auditory cue, such as a regular beat or pulse, as part of rehabilitation can improve walking. It is also recommended that early rehabilitation following stroke delivers the bestoutcome for patients.
Study aim:To determine whether the use of auditory cueing in early stroke rehabilitation is feasible during a balance and gait therapy programme.
Study participants: Adults following acute stroke with walking problems. Participants must be able to sit unsupported and stand with assistance of 1 or 2 people. They will be recruited from the acute stroke unit at North Tyneside General Hospital 2 days to 4 weeks following stroke. A total of 12 participants will be recruited.
Study setting: Acute stroke unit - North Tyneside General Hospital and participants homes if they are discharged within the study period.
Intervention:Participants will receive auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 / week for 3 weeks within the physiotherapy gym on the stroke unit or at home if discharged within the intervention period. The 30 minutes will consist of balance exercises and walking practice using auditory cueing with a metronome.
Measures:1. What the participants and the therapists think of the intervention will be assessed by questionnaires. The questionnaires contain open and closed questions and have been developed specifically for this study.
2.The stroke survivors trunk control, balance and walking will be assessed before and after the intervention.
Study Duration: 12 months
Future Plans: This study will be used to inform a larger study testing if the intervention works and how much it costs
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults within 2 days to 3 weeks following acute stroke with residual mobility problems. They must be able to sit unsupported, stand with assistance of 1- 2 people and be able to comply with the intervention programme.
Key inclusion criteria (4 listed)
- Adults (> 18 years) following acute stroke (any subtype) with residual mobility problems
- Within 2 days - 4 weeks post-stroke.
- Be able to sit unsupported and stand with assistance of 1 or 2 people
- Able to provide informed consent to participate in the study.
Key exclusion criteria (2 listed)
- Unable to follow the intervention due to cognitive or language impairment.
- Other medical problems affecting walking and balance (e.g. Parkinson's Disease, severe osteoarthritis and cardiopulmonary conditions).
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 |
|---|---|---|
| Auditory rhythmical cueingAuditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 per week for 3 weeks. | Other | – |
Primary outcome
Participant questionnaire
Time frame: 3 weeks
To seek views of patients on the intervention programme
Therapist questionnaire
Time frame: 3 weeks
To seek views from therapists on the intervention programme
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 12 Mar 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?
An observational study of Stroke, run by Northumbria Healthcare NHS Foundation Trust 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 4 inclusion and 2 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 12 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 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?
Participant questionnaire (time frame: 3 weeks). The study lists 2 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 12 Mar 2021.