StrokeNCT04491279
Neuropilates Compared to General Exercise Classes in Chronic Stroke
A study testing Home 'General' exercise instructions., Home 'Neuropilates' exercise instructions. and Supervised Neuropilates Group Class in people with Stroke, run by Dr. John Bartlett at 1 site in Ireland.
Trial summary
This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Home 'General' exercise instructions., Home 'Neuropilates' exercise instructions. and Supervised Neuropilates Group Class
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 30 Oct 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 years
- Diagnosis of chronic stroke (>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed.
- Able to transfer (sit to stand and lateral transfers) independently with or without assistive device
- Access to transport to enable attendance at one class per week
- Cognitive ability to understand the programme.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study
This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. The study will be conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.
Read the detailed description
Pilates is an exercise form created by Joseph Pilates in the 1920s. It is a programme of mind-body exercise focusing on strength, core stability, flexibility, muscle control, posture and breathing. Neuropilates is the practice of clinical pilates in patients with a neurological condition. The exercise is ideally led by a clinician with experience and expertise in the area and uses postural, positional and equipment adaptations as necessary to suit the needs of the client. The benefits derived from pilates exercise of balanced strength with improved alignment, postural control and flexibility, could be favourable to post stroke patients who often have one-sided loss of strength and muscle length and subsequent adverse postural adaptations and abnormal movement patterns.
This study aims to investigate the effects of a 6-week neuropilates class in post stroke patients, when compared with a 6-week generalised exercise class. Participants will be assessed before and after partaking in either class in order to examine their gait, functional independence and spasticity. Participants will then be randomly assigned to either the 6-week neuropilates class or generalised exercise class. Participants will be 6 or more months post stroke and finished their formal rehabilitation. Participants should not be involved with any other rehabilitation therapies / hydrotherapy / gym services for the duration of the study. We will aim to recruit 30 participants to the study. The intervention group will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). The control group will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Both exercise classes will take place in the Physiotherapy Department in St. John's Hospital, Sligo, Ireland
- Conditions
- Stroke
- Being tested
- Home 'General' exercise instructions., Home 'Neuropilates' exercise instructions., Supervised Neuropilates Group Class, Supervised General Exercises Group Class
- Keywords
- Neuroplasticity, Neuropilates, Chronic Stroke, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home 'General' exercise instructions.Procedure or surgery
Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.
Home 'Neuropilates' exercise instructions.Procedure or surgery
Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.
Supervised Neuropilates Group ClassProcedure or surgery
Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor).
Supervised General Exercises Group ClassProcedure or surgery
Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility
| Study group | Role | What they receive |
|---|---|---|
| Neuropilates class. | Experimental | Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor).
Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate.
Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant.
Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants.
Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary. Receives: Procedure: Home 'Neuropilates' exercise instructions.; Procedure: Supervised Neuropilates Group Class |
| Generalised exercise class. | Active comparator | Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility.
Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class.
Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary. Receives: Procedure: Home 'General' exercise instructions.; Procedure: Supervised General Exercises Group Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Assessment Scale (Carr and Shepherd 1985).
A performance-based scale to assess everyday motor function in post stroke patients. Evaluation is based upon a task-orientated approach. The scale comprises 8 items corresponding to 8 areas of motor function. Patients perform each task 3 times and the best performance is recorded. Tasks include; Supine to side lying, Supine to sitting over the edge of a bed, Balanced sitting, Sitting to standing, Walking, Upper-arm function, Hand movements, Advanced hand activities.
General tonus of the affected side is also measured. All items (with the exception of the general tonus item) are assessed using a 7-point scale from 0 - 6. A score of 6 indicates optimal motor behaviour. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response. A score > 4 indicates persistent hypertonus and a score < 4 indicates various degrees of hypotonus. The maximum score possible is 48 points.
Measured: Over a 6 week period. (15 min testing time).
Secondary outcomes (5)
Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000).
Assesses functional mobility and can be used as a screening tool for detecting potential balance impairments and falls risk in older adults. During the test the subject must rise from a chair, walk 3 metres at a comfortable pace to a mark placed on the floor, turn around at the 3 metre mark, walk back to the starting point, and return to sitting in the chair. The test's score is the time it takes the subject takes to complete the test. The longer it takes the poorer the patient function.If a subject takes longer than 14 seconds to complete the test, they are considered to be at a high risk of falling.
Measured: Over a 6 week period. (1 min testing time).
Muscle Strength: Oxford Grading Scale.
Most commonly accepted method of evaluating muscle strength. It involves testing key muscles from the upper and lower limbs against resistance applied by the examiner. The subject's strength is graded on a 0 - 5 scale with 0 being no movement or muscle activity visible or palpable and 5 being full strength through full range against strong resistance. It can take a few minutes up to 20 minutes to test, depending on the experience level of the examiner, the ability of the subject and the number of muscle groups being tested.
Measured: Over a 6 week period. (5-20 min testing time).
Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987).
Measure muscle tone. During testing, the examiner extends the subject's limb from a position of maximal flexion to maximal extension until the first soft resistance is felt. Moving a client's limb through its full range of motion should be done within one second by counting "one thousand and one" Scores range from 0 to 4 where lower scores represent normal muscle tone and higher scores represent increased tone (spasticity) or increased resistance to passive movement. Again, time varies greatly depending on number of muscles being tested, examiner experience and patient ability, and can range from 5 minutes to 20 minutes.
Measured: Over a 6 week period. (5-20 min testing time).
Function: Functional Independence Measure (FIM), (Granger et al 1993).
The FIM is a valid, reliable, 18-item global measure of disability, which is responsive to functional change. The FIM assesses six areas of function (Self-care, Sphincter control, Transfers, Locomotion, Communication and Social cognition), which fall under two Domains (Motor and Cognitive). Each item on the FIM is scored on a 7-point Likert scale. The score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). The ratings are based on performance rather than capacity and can be acquired by observation, patient interview, telephone interview or medical records. The developers of the FIM recommend that the scoring be derived by consensus with a multi-disciplinary team. The final score can range from 18 - 126 points, where 18 represents complete dependence or total assistance and 126 represents complete independence.
Measured: Over a 6 week period. (30-45 min testing time).
London Handicap Scale (LHS), (Harwood et al 1994).
Generates a profile of handicaps on 6 different dimensions, including mobility, independence, occupation, social integration, orientation, and economic self-sufficiency. Each dimension has six levels arranged in order of increasing disadvantage with 1 being no disadvantage and 6 being most severe disadvantage. An overall handicap severity score is generated.
Measured: Over a 6 week period. (5 min testing time).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start30 Oct 2020
- Primary completion30 Apr 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. John Bartlett
- Sponsor type
- University, hospital or other
- Collaborators
- Sligo General Hospital, Institute of Technology, Sligo
- Responsible party
- Sponsor-investigator, Dr. John Bartlett, Institute of Technology, Sligo
- Investigators
- Eimear Cronin, MSc Res, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491279
- Sponsor's protocol ID
- ITSligo EC
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2020
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cronin E, Burns R, Lynch P, Hickey M, Monaghan K. Online neuropilates exercise classes for post stroke patients: A randomised feasibility study. J Bodyw Mov Ther. 2025 Oct;44:200-210. doi: 10.1016/j.jbmt.2025.05.067. Epub 2025 May 27.
PubMed 40954583Cronin E, Monaghan K. Online neuropilates classes in chronic stroke patients: Protocol for a randomised controlled feasibility study. Contemp Clin Trials Commun. 2023 Jan 20;32:101068. doi: 10.1016/j.conctc.2023.101068. eCollection 2023 Apr.
PubMed 36747990
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT04491279
- Acronym / sponsor ID
- ITSligo EC
- Conditions
- Stroke
- Keywords
- Neuroplasticity, Neuropilates, Chronic Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. John BartlettUniversity, hospital or other
- Collaborators
- Sligo General Hospital, Institute of Technology, Sligo
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. The study will be conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.
Detailed description
Pilates is an exercise form created by Joseph Pilates in the 1920s. It is a programme of mind-body exercise focusing on strength, core stability, flexibility, muscle control, posture and breathing. Neuropilates is the practice of clinical pilates in patients with a neurological condition. The exercise is ideally led by a clinician with experience and expertise in the area and uses postural, positional and equipment adaptations as necessary to suit the needs of the client. The benefits derived from pilates exercise of balanced strength with improved alignment, postural control and flexibility, could be favourable to post stroke patients who often have one-sided loss of strength and muscle length and subsequent adverse postural adaptations and abnormal movement patterns.
This study aims to investigate the effects of a 6-week neuropilates class in post stroke patients, when compared with a 6-week generalised exercise class. Participants will be assessed before and after partaking in either class in order to examine their gait, functional independence and spasticity. Participants will then be randomly assigned to either the 6-week neuropilates class or generalised exercise class. Participants will be 6 or more months post stroke and finished their formal rehabilitation. Participants should not be involved with any other rehabilitation therapies / hydrotherapy / gym services for the duration of the study. We will aim to recruit 30 participants to the study. The intervention group will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). The control group will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Both exercise classes will take place in the Physiotherapy Department in St. John's Hospital, Sligo, Ireland
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Neuropilates class. | Experimental | Procedure: Home 'Neuropilates' exercise instructions., Procedure: Supervised Neuropilates Group ClassWill attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor). Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate. Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant. Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants. Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary. |
| Generalised exercise class. | Active comparator | Procedure: Home 'General' exercise instructions., Procedure: Supervised General Exercises Group ClassWill attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class. Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged > 18 years
- Diagnosis of chronic stroke (>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed.
- Able to transfer (sit to stand and lateral transfers) independently with or without assistive device
- Access to transport to enable attendance at one class per week
- Cognitive ability to understand the programme.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home 'General' exercise instructions.Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary. | Procedure or surgery | Generalised exercise class. |
| Home 'Neuropilates' exercise instructions.Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary. | Procedure or surgery | Neuropilates class. |
| Supervised Neuropilates Group ClassWill attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). | Procedure or surgery | Neuropilates class. |
| Supervised General Exercises Group ClassWill attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility | Procedure or surgery | Generalised exercise class. |
Primary outcome
Motor Assessment Scale (Carr and Shepherd 1985).
Time frame: Over a 6 week period. (15 min testing time).
A performance-based scale to assess everyday motor function in post stroke patients. Evaluation is based upon a task-orientated approach. The scale comprises 8 items corresponding to 8 areas of motor function. Patients perform each task 3 times and the best performance is recorded. Tasks include; Supine to side lying, Supine to sitting over the edge of a bed, Balanced sitting, Sitting to standing, Walking, Upper-arm function, Hand movements, Advanced hand activities. General tonus of the affected side is also measured. All items (with the exception of the general tonus item) are assessed using a 7-point scale from 0 - 6. A score of 6 indicates optimal motor behaviour. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response. A score > 4 indicates persistent hypertonus and a score < 4 indicates various degrees of hypotonus. The maximum score possible is 48 points.
5 secondary outcomes
Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000).
Time frame: Over a 6 week period. (1 min testing time).
Muscle Strength: Oxford Grading Scale.
Time frame: Over a 6 week period. (5-20 min testing time).
Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987).
Time frame: Over a 6 week period. (5-20 min testing time).
Function: Functional Independence Measure (FIM), (Granger et al 1993).
Time frame: Over a 6 week period. (30-45 min testing time).
London Handicap Scale (LHS), (Harwood et al 1994).
Time frame: Over a 6 week period. (5 min testing time).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 40954583Cronin E, Burns R, Lynch P, Hickey M, Monaghan K. Online neuropilates exercise classes for post stroke patients: A randomised feasibility study. J Bodyw Mov Ther. 2025 Oct;44:200-210. doi: 10.1016/j.jbmt.2025.05.067. Epub 2025 May 27.
- Derived from this study: PubMed 36747990Cronin E, Monaghan K. Online neuropilates classes in chronic stroke patients: Protocol for a randomised controlled feasibility study. Contemp Clin Trials Commun. 2023 Jan 20;32:101068. doi: 10.1016/j.conctc.2023.101068. eCollection 2023 Apr.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eimear Cronin, MSc Res principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home 'General' exercise instructions., Home 'Neuropilates' exercise instructions. and Supervised Neuropilates Group Class in people with Stroke, run by Dr. John Bartlett at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Assessment Scale (Carr and Shepherd 1985). (time frame: Over a 6 week period. (15 min testing time).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024; AzTrials last refreshed its copy on 2 Nov 2026.