Clinical trial NCT04491279: Neuropilates Compared to General Exercise Classes in Chronic Stroke
Official title: An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Neuroplasticity
Neuropilates
Chronic Stroke
Rehabilitation
Lead sponsor: Institute of Technology, Sligo
Sponsor class: OTHER
Collaborators: name: Sligo General Hospital
name: Institute of Technology, Sligo
First posted: 2020-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomised Controlled Trial
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

1. Aged \> 18 years
2. Diagnosis of chronic stroke (\>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed.
3. Able to transfer (sit to stand and lateral transfers) independently with or without assistive device
4. Access to transport to enable attendance at one class per week
5. Cognitive ability to understand the programme.

Exclusion Criteria:

1. Involvement in other studies or rehabilitation programmes.
2. Severe cognitive deficits or difficulty following instructions.
3. Significant hearing difficulties.
4. Significant visual deficit
5. Uncontrolled pain or uncontrolled high blood pressure

Primary outcomes:
measure: Motor Assessment Scale (Carr and Shepherd 1985).
timeFrame: Over a 6 week period. (15 min testing time).
Secondary outcomes:
measure: Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000).
timeFrame: Over a 6 week period. (1 min testing time).
measure: Muscle Strength: Oxford Grading Scale.
timeFrame: Over a 6 week period. (5-20 min testing time).
measure: Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987).
timeFrame: Over a 6 week period. (5-20 min testing time).
measure: Function: Functional Independence Measure (FIM), (Granger et al 1993).
timeFrame: Over a 6 week period. (30-45 min testing time).
measure: London Handicap Scale (LHS), (Harwood et al 1994).
timeFrame: Over a 6 week period. (5 min testing time).
Other outcomes:
Locations:
city: Sligo
country: Ireland
facility: Institute of Technology, Sligo
state: Co Sligo
Study officials:
affiliation: Study Principal Investigator
name: Eimear Cronin, MSc Res
role: PRINCIPAL_INVESTIGATOR
References: