A feasibility study exploring a community walking programme using a metronome sound beat to improve stepping and daily activity following a stroke
| ISRCTN | ISRCTN10874601 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10874601 |
| Secondary identifying numbers | 37058 |
- Submission date
- 05/03/2018
- Registration date
- 12/03/2018
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A stroke occurs when the blood supply to part of the brain is cut off. People who survive a stroke are often left with long-term problems. The aims of this study are to confirm the acceptability of a home-based auditory rhythmical cueing (ARC) treatment to improve gait and physical activity after stroke, and to assess the feasibility of a larger study of the ARC treatment.
Who can participate?
Community-dwelling stroke survivors aged 18 and over with the ability to walk 10 metres with/without a stick indoors, who are not undertaking active physiotherapy, are able to comply with the intervention and have a gait-related impairment that would potentially benefit from the intervention
What does the study involve?
Participants are randomly allocated to one of two groups. In the intervention group participants undertake 18 ARC home and community treatment sessions over six weeks (3 x 30 minutes per week, 6 supervised by a study provider and 12 self-managed). During the treatment sessions a metronome is used to provide auditory rhythmic cueing during a series of balance and gait exercises which are gradually be progressed over the 6-week programme. Training handouts and videos are provided to support the self-management treatment sessions. Participants in the control group undertake the same duration balance and gait exercise treatment as the intervention group but without ARC. The acceptability of the study treatments and the feasibility of the study protocol are assessed (recruitment, retention, side effects, treatment delivery, outcome measures) to inform the design of a larger study.
What are the possible benefits and risks of participating?
The results of this study will help to plan for a larger study that will test whether the auditory rhythmic cueing programme is an effective treatment for stroke-related gait impairment, and whether this intervention provides good value for money. There are no risks anticipated.
Where is the study run from?
1. Northumbria Healthcare NHS Foundation Trust (UK)
2. Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
3. Durham and Darlington NHS Foundation Trust (UK)
4. Gateshead Health NHS Foundation Trust. Consent (UK)
When is the study starting and how long is it expected to run for?
July 2017 to June 2020
Who is funding the study?
Stroke Association (UK)
Who is the main contact?
Sarah Moore
Contact information
Scientific
Stroke Research Group
Newcastle University
3 – 4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
 ORCID ID |
0000-0003-3158-4750 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Acceptability and clinical trial feasibility evaluation of auditory rhythmical cueing to improve gait and physical activity in community dwelling stroke survivors |
| Study acronym | ACTIVATE V1 |
| Study objectives | Study aim: To confirm the acceptability of a home-based auditory rhythmical cueing (ARC) treatment to improve gait and physical activity after stroke and to assess the feasibility of a multi-centre, observer blind parallel group randomised controlled trial (RCT) of the ARC treatment. |
| Ethics approval(s) | London City and East Research Ethics Board, 22/01/2018, ref: 18/LO/0115 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Study design: Before and after study followed by a multi-centre observer blind, parallel group, pragmatic pilot randomised controlled trial. Study setting: Home and community settings in North East England. Study participants: Adult community dwelling stroke survivors with the ability to walk 10 metres with/without a stick indoors who are not undertaking active physiotherapy, are able to comply with the intervention and have a gait-related impairment that would potentially benefit from the intervention. 12 participants will be recruited to the before and after study (8 intervention and 4 controls) and 60 to the RCT. Study treatments to be used in the before and after study and RCT: Intervention treatment: Participants will undertake 18 ARC home and community treatment sessions over six weeks (3 x 30 minutes per week, 6 supervised by a study provider/12 self-managed. During the treatment sessions a metronome will be used to provide auditory rhythmic cueing during a series of balance and gait exercises which will gradually be progressed over the six week programme. Training handouts and videos will be provided to support the self-management treatment sessions. Control treatment: Participants in the control group will undertake the same duration balance and gait exercise treatment as the intervention group but without ARC. Study outcomes: The before and after study will confirm the acceptability of the study treatments. The RCT will then test the feasibility of the study protocol (recruitment, retention, adverse events, treatment delivery, outcome measures) and provide data to inform the design of a future multi-centre RCT. Study duration: 28 months. |
| Intervention type | Other |
| Primary outcome measure | This study includes a before and after study and a pilot to assess the feasibility of a multicentre, randomised controlled trial of auditory rhythmic cueing to improve gait and physical activity after stroke. Both study designs do not require a primary outcome as only collecting descriptive and feasibility data are collected. The primary aim of this study is to establish the feasibility of a future randomised controlled trial; as such its aims are: 1. To confirm acceptability of study treatments (intervention and control) 2. To confirm treatment delivery in a subsequent pilot randomised controlled trial The trialists will also evaluate whether the following objectives have been met, prior to planning a future randomised controlled trial: 1. To seek views of participants and providers on the intervention and control treatments 2. To ensure appropriate fidelity of the delivery and enactment of treatments 3. To collate summary data on outcome measures and accelerometer data 4. To collate summary data on falls and adverse events pertaining to the treatments 5. To collate findings from the above to confirm acceptability of the treatments which will then be used in the pilot randomised controlled trial |
| Secondary outcome measures | Demographic and stroke characteristics, taken at baseline assessment only: 1. Stroke impairment measured using NIHSS 2. Disability measured using Modified Rankin Scale 3. Cognition measured using Montreal Cognitive Assessment 4. Depression measured using Physical Health Questionnaire 5. Fatigue measured using Fatigue Assessment Scale Gait, balance, physical activity and health outcome measures. completed at baseline, 6 week and 10 week assessments: 1. Ambulation ability measured using Functional Ambulation Category and Rivermead Mobility Assessment 2. Gait characteristics measured using 4 metre walk test x 5 and postural control 2 minute standing test (Stop watch and accelerometer measured) 3. Balance measured using Mini Balance Evaluation Systems Test and Activities-Specific Balance Confidence Scale 4. Ambulatory participation measured using Stroke Impact Scale 5. Physical activity measured using 7-day data recorded by accelerometry 6. Health outcome measured using the EuroQol 5 Dimension 3 Level EQ-5D-3L Further data collection on completion of study: 1. Participant self-report views of treatment 2. Treatment providers views of the treatment |
| Overall study start date | 01/07/2017 |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 72; UK Sample Size: 72 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Adults (≥ 18 years) 2. Diagnosed with any stroke subtype 3. Within 24 months of stroke onset 4. Able to mobilise independently >10 metres with/without stick indoors but presenting with a gait-related mobility impairment (e.g. gait asymmetry, reduced walking speed, reduced balance, reduced walking confidence based on clinical observation or patient subjective feedback) that would potentially benefit from this intervention 5. Community dwelling 6. Living within the community services catchment area of a participating study centre 7. Able to provide informed consent to participate in the study 8. Able to follow study treatment (i.e. does not have significant cognitive impairment or communication difficulties) |
| Key exclusion criteria | 1. Currently undertaking active physiotherapy 2. Unable to follow programme due to significant cognitive impairment or communication difficulties Marked expressive/receptive dysphasia 3. Diagnosis likely to interfere with adherence to treatment or predispose to falls e.g. uncorrected hearing problems, registered blind, severe visual/inattention problems as a result of stroke, upper limb impairment restricting use of cueing device and able to mobilise 10 metres but extremely slow gait speed limited intervention adherence 4. Other neurological or orthopaedic conditions affecting gait (e.g. Parkinson's Disease, Multiple Sclerosis, osteoarthritis, rheumatoid arthritis and back pain) and cardiopulmonary conditions limiting walking ability (e.g. chronic obstructive disorders, angina pectoris) and palliative treatment |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 28/02/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
North Shields
NE29 8NH
United Kingdom
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
King Street
Darlington
DL3 6JL
United Kingdom
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Ms Caroline Potts
Research and Development Department
Northumbria Healthcare NHS Trust
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
England
United Kingdom
"ROR" |
https://ror.org/01gfeyd95 |
|---|
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/05/2020 | 01/06/2020 | Yes | No |
| Results article | 12/11/2022 | 14/11/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
14/11/2022: Publication reference added.
01/06/2020: Publication reference added.
09/03/2020: The total final enrolment was added.
27/03/2019: The condition has been changed from "Specialty: Stroke, Primary sub-specialty: Rehabilitation; UKCRC code/ Disease: Stroke/ Cerebrovascular diseases" to "Stroke" following a request from the NIHR.
