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

Sponsor
Northumbria Healthcare NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04795115
Collaborator
(none)
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6.1
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Study Details

Study Description

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 Phase
  • Other: Auditory rhythmical cueing

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
12 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Feasibility and Acceptability of an Auditory Rhythmical Cueing Intervention Targeting Balance and Gait in Early Rehabilitation (ARCAS)
Actual Study Start Date :
Feb 4, 2019
Actual Primary Completion Date :
May 31, 2019
Actual Study Completion Date :
Aug 8, 2019

Outcome Measures

Primary Outcome Measures

  1. Participant questionnaire [3 weeks]

    To seek views of patients on the intervention programme

  2. Therapist questionnaire [3 weeks]

    To seek views from therapists on the intervention programme

Other Outcome Measures

  1. Functional Ambulatory category [3 weeks]

    Functional walking test that evaluates ambulation ability - score 0-5

  2. Trunk Impairment Scale [3 weeks]

    measures trunk control - Score 0-23

  3. Trunk ControlTest [3 weeks]

    To assess motor impairment - Score 0-100

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 North Tyneside General Hospital Newcastle Upon Tyne Tyne And Wear United Kingdom NE29 8NH

Sponsors and Collaborators

  • Northumbria Healthcare NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northumbria Healthcare NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04795115
Other Study ID Numbers:
  • 0031
First Posted:
Mar 12, 2021
Last Update Posted:
Mar 12, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 12, 2021