Clinical trial NCT04795115: The ARCAS Study: Auditory Rhythmical Cueing for Gait in Acute Stroke
Official title: Feasibility and Acceptability of an Auditory Rhythmical Cueing Intervention Targeting Balance and Gait in Early Rehabilitation (ARCAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Northumbria Healthcare NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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


Eligibility 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).

Primary outcomes:
measure: Participant questionnaire
timeFrame: 3 weeks
measure: Therapist questionnaire
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
measure: Functional Ambulatory category
timeFrame: 3 weeks
measure: Trunk Impairment Scale
timeFrame: 3 weeks
measure: Trunk ControlTest
timeFrame: 3 weeks
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: North Tyneside General Hospital
state: Tyne And Wear
Study officials:
References: