Online Neuropilates Classes in Chronic Stroke Patients: A Pilot Randomised Feasibility Study
An Investigation in Online Neuropilates Classes in Chronic Stroke Patients: A Pilot Randomised Feasibility Study'
1 other identifier
interventional
12
1 country
1
Brief Summary
This study is being undertaken as part of a PhD qualification at ATU Sligo by the principal researcher Eimear Cronin. It will investigate the feasibility, safety and efficacy of a 6 week, online, remotely supervised neuropilates programme in post stroke participants as compared to a 6 week, online, remotely supervised generalised exercise programme and a 6 week unsupervised home exercise programme
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Nov 2022
Shorter than P25 for not_applicable stroke
1 active site
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
Study Start
First participant enrolled
November 16, 2022
CompletedFirst Submitted
Initial submission to the registry
February 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2023
CompletedSeptember 29, 2023
September 1, 2023
6 months
February 12, 2023
September 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Timed Up and Go Assessment (Podsiadlo and Richardson 1991)
The TUG will be used as a measure of basic functional mobility. The participants will be instructed to stand from a standard arm chair, walk 3 metres to a specified line, turn, walk back and sit.
Over a 6 week period, 2-3 minute assessment
Tinetti Balance and Gait Assessment (Tinetti et al, 1986)
The Tinetti test was chosen as a measure of balance and gait. The test uses a 3-point ordinal scale of 0,1 and 2 points. Gait is scored out of 12 points and balance is scored out of 16 points, totalling 28 points. The lower the score, the higher the risk of falling
Over a 6 week period, 15 minute assessment
The Activites Specific Balance Confidence Scale (Powell and Myers 1995)
The ABC scale is a 16 item self-report measure in which patients rate their balance confidence for performing activities. Scoring is from 0 to 100 with 0 being no confidence and 100 being full confidence. It was chosen for the initial assessment to measure balance confidence, but also to guide the treating therapist in recommending whether or not the patient would need supervision during the exercise sessions.
Over a 6 week period, 10 minute assessment
Secondary Outcomes (3)
5 Times Sit to Stand Test (Csuka and Mccarthy 1985)
Over a 6 week period, 2 - 3 minute assessment
The Stroke Specific Quality of Life Scale (Williams et al, 1999)
Over a 6 week period. 20 minute assessment
The Modified Ashworth Scale (Bohannon and Smith 1987)
Over a 6 week period, 20 minute assessment
Study Arms (3)
Intervention
EXPERIMENTALParticipants in the intervention group will participate in a once weekly, 6 week online, remotely supervised neuropilates programme. Exercises will be taught by a chartered Physiotherapist who is also a pilates instructor with experience with stroke rehabilitation. Exercises will be aligned to the Australian Physiotherapy and Pilates Institute's (r) core teaching with modifications based on participant need and aligned to neurorehabilitation principles
Control Group A
ACTIVE COMPARATORParticipants in control group A will participate in a once weekly, 6 week, online, remotely supervised generalised exercise class. This class will be instructed by a chartered Physiotherapist and will consist of general strengthening and flexibility exercises for upper and lower limbs.
Control Group B
ACTIVE COMPARATORParticipants in control group B will be given a tailored, individualised home exercise programme to practice unsupervised at home over a 6 week period. They will receive a follow up phone call to discuss any issues they might be having and a training diary to log their exercise.
Interventions
Online, remotely supervised neuropilates exercise class
Online, remotely supervised generalised exercise class
Unsupervised, home based generalised exercise programme
Eligibility Criteria
You may qualify if:
- Aged \> 18 years
- Diagnosis of chronic stroke (\>6 months post stroke event \[30\]) and formal rehabilitation completed.
- Able to transfer and mobilise \> 10 metres independently with or without assistive device
- Internet access in their homes: Wifi or access to someone with mobile data
- Cognitive ability to understand the programme.
You may not qualify if:
- Involvement in other studies or rehabilitation programmes.
- Severe cognitive deficits or difficulty following instructions.
- Significant hearing difficulties.
- Significant visual deficit
- Uncontrolled pain or uncontrolled high blood pressure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Technology, Sligolead
- Sligo General Hospitalcollaborator
Study Sites (1)
Atlantic Technological University
Sligo, Ireland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kenneth Monaghan, PhD
Research Supervisor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessor will be blinded to treatment allocation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Kenneth Monaghan
Study Record Dates
First Submitted
February 12, 2023
First Posted
February 22, 2023
Study Start
November 16, 2022
Primary Completion
May 22, 2023
Study Completion
May 24, 2023
Last Updated
September 29, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be stored for a period of 5 years and then erased or shredded
- Access Criteria
- As data will be irrevocably annonymised, data will be shared with researchers conducting systematic literature reviews or cochrane reviews if required
As this is an RCT, the possibility exists that this data could be included in a future Cochrane review and thus, it is important to retain data. Retention of irrevocably anonymised and coded hard and electronic data by ATU Sligo for scientific purposes is done for assessment purposes for the obtainment of a PhD qualification by the principal researcher. Data will also be disseminated and published by peer-reviewed journals.