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Completed

NCT Number: NCT04795115

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Tyneside General Hospital

Newcastle upon Tyne, Tyne and Wear, NE29 8NH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Auditory rhythmical cueing

Other

Auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 per week for 3 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northumbria Healthcare NHS Foundation Trust

Other

Registry information

Official study title

Feasibility and Acceptability of an Auditory Rhythmical Cueing Intervention Targeting Balance and Gait in Early Rehabilitation (ARCAS)

Acronym: ARCAS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2021
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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