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Self-management intervention for mobility for people with stroke

Feasibility of a self-management intervention for improving mobility for patients following stroke in the community

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15728885
Enrollment
90
Registered
2021-09-30
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation of mobility for people in subacute stage post-stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

The participants will be randomly allocated to treatment or control groups by an administrator using a computer-generated randomisation chart. The treatment group will receive the self-management inte

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals will be eligible to participate in the study if they: 1. Are adults (18 years to 99 years) 2. Have had a diagnosis of a first stroke 3. Are within the first 3 months post-discharge from the hospital. This will be extended to participants who have had a stroke within the past 6 months 4. With Functional Ambulation Category (FAC) 2. This means that the person is at least able to walk with a maximum of one person assistance, with or without a gait aid (Mehrholz et al., 2007) 5. Have cognitive capacity that allows them to communicate and consent to participate in the study. The Montreal Cognition assessment (MoCA) (Cumming et al., 2013) and the FAC will be used for screening. Moreover, clinicians will be involved in determining patient’s ability to participate prior to approaching any participant about this study 6. Can understand English. However, the feasibility of including participants who speak Punjabi or Urdu will be explored using translated information sheets and interpreters when possible using family members who speak English 7. Have access to a suitable device that can launch the ZOOM Programme

Exclusion criteria

Exclusion criteria: Patients will be excluded if they: 1. Are unable to participate or unable to give consent to participate in the programme due to marked cognitive impairment 2. Suffer from severe cardiopulmonary diseases or severe arthritis or have other major co-morbidities, which might be a risk for community walking 3. Have severe aphasia 4. Have severe spasticity or fatigue post stroke

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate: the number of participants who consent to participate in the study by 6 months 2. Retention rate: the number of participants who consent to participate who remain in the study until the end of follow up at 6 months 3. Evaluation of the randomisation and blinding process and ability to reduce contamination using descriptive analysis of the process at the end of data collection period (12 months) 4. Eligibility criteria evaluated using the number of participants eligible for each criterion measured at the end of the recruitment period (6 months) 5. Participants’ adherence to the intervention and follow up (the number of days the participants did their exercise and recorded in diary) measured every 2 weeks in a phone call with the researcher and at 6 months 6. Fidelity and acceptability of the new intervention: the lived experiences and perspectives of participants about the intervention collected using focus groups at 6 months (3 months from the end of the intervention period 7. Feasibility of the self-management and performance outcome measures (the validity of selected initial outcomes) measured using descriptive analysis at the end of the study (12 months)

Secondary

MeasureTime frame
1. Self-efficacy assessed using the stroke self-efficacy questionnaire at baseline, 3 months (end of intervention) and 6 months (follow up) 2. Goal achievement measured using the Goal Attainment Scale (GAS) every 2 weeks in a phone call with the researcher 3. Functional mobility measured using the Functional Gait Assessment (FGA) at baseline, 3 months (end of intervention) and 6 months (follow up) 4. Balance, mobility, and walking ability measured using the Timed Up and Go (TUG) at baseline, 3 months (end of intervention) and 6 months (follow up) 5. Walking endurance measured using the 6 Minutes Walking Test (6MWT) at baseline, 3 months (end of intervention) and 6 months (follow up) 6. Maximum walking speed measured using the 10-meter Walking Test (10-mWT) at baseline, 3 months (end of intervention) and 6 months (follow up) 7. Walking distance measured using a pedometer, collected every two weeks in a phone call with the researcher 8. Cognitive status measured using the Montreal Cognitive Assessment (MoCA) at baseline, 3 months (end of intervention) and 6 months (follow up) 9. General health status measured using the General Health Questionnaire-12 at baseline, 3 months (end of intervention) and 6 months (follow up)

Countries

England, United Kingdom, Wales

Contacts

Public ContactAhmad Sahely
axs1638@student.bham.ac.uk+44 7564 179 129

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026