NCT04795115

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

January 9, 2019

Last Update Submit

March 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Functional Ambulatory category

    3 weeks

  • Trunk Impairment Scale

    3 weeks

  • Trunk ControlTest

    3 weeks

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Tyneside General Hospital

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

March 12, 2021

Study Start

February 4, 2019

Primary Completion

May 31, 2019

Study Completion

August 8, 2019

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations