A feasibility study exploring a community walking programme using a metronome sound beat to improve stepping and daily activity following a stroke

Conditions

Stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Shaw L, McCue P, Brown P, Buckley C, Del Din S, Francis R, Hunter H, Lambert A, Lord S, Price CIM, Rodgers H, Rochester L, Moore SA.

2022-11-122 citations

10.1186/s40814-022-01193-y

Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial.

McCue P, Del Din S, Hunter H, Lord S, Price CIM, Shaw L, Rodgers H, Rochester L, Moore SA.

2020-05-193 citations

10.1186/s40814-020-00605-1

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Outcome results

None listed