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

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.

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 Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Auditory rhythmical cueing

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE29 8NH
      • North Tyneside General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant questionnaire	To seek views of patients on the intervention programme	3 weeks
Therapist questionnaire	To seek views from therapists on the intervention programme	3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulatory category	Functional walking test that evaluates ambulation ability - score 0-5	3 weeks
Trunk Impairment Scale	measures trunk control - Score 0-23	3 weeks
Trunk ControlTest	To assess motor impairment - Score 0-100	3 weeks

Collaborators and Investigators

• Sponsor: Northumbria Healthcare NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No