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The ARCAS Study: Auditory Rhythmical Cueing for Gait in Acute Stroke (ARCAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795115
Recruitment Status : Completed
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Northumbria Healthcare NHS Foundation Trust

Study Description
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Brief 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. 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


Condition or disease Intervention/treatment
Stroke Other: Auditory rhythmical cueing

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 12 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 3 Weeks
Official Title: Feasibility and Acceptability of an Auditory Rhythmical Cueing Intervention Targeting Balance and Gait in Early Rehabilitation (ARCAS)
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : August 8, 2019
Groups and Cohorts
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Intervention Details:
  • Other: Auditory rhythmical cueing
    Auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 per week for 3 weeks.

Outcome Measures
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Primary Outcome Measures :
  1. Participant questionnaire [ Time Frame: 3 weeks ]
    To seek views of patients on the intervention programme

  2. Therapist questionnaire [ Time Frame: 3 weeks ]
    To seek views from therapists on the intervention programme


Other Outcome Measures:
  1. Functional Ambulatory category [ Time Frame: 3 weeks ]
    Functional walking test that evaluates ambulation ability - score 0-5

  2. Trunk Impairment Scale [ Time Frame: 3 weeks ]
    measures trunk control - Score 0-23

  3. Trunk ControlTest [ Time Frame: 3 weeks ]
    To assess motor impairment - Score 0-100


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795115


Locations
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United Kingdom
North Tyneside General Hospital
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE29 8NH
Sponsors and Collaborators
Northumbria Healthcare NHS Foundation Trust
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Northumbria Healthcare NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04795115    
Other Study ID Numbers: 0031
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases