An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study
Phase: NA
Conditions: Stroke
Sponsor: Dr. John Bartlett

 
 
 
Study Protocol 
 
Study Title: 
 
An investigation into neuropilates on motor function in chronic stroke: a pilot randomised 
feasibility study 
 
Document creation date: August 4th 2020 
 
NCT number [not yet assigned].  
 
Identifiers: [NCT ID not yet assigned]  
 
 

 
 Study Protocol 
 
 
Study Aim:  
 
To examine the effects of a 6 week “neuropilates” exercise class compared to a generalised 
exercise class on gait and functional outcome in chronic stroke patients. 
 
Study Objectives: 
 
1. To conduct a randomised controlled pilot feasibility study to examine the effects on gait and 
functional outcome in an intervention group participating in a once weekly supervised, 6-week 
neuropilates exercise class when compared to a control group participating in a once weekly 
supervised, 6-week generalised exercise class. All participants will also be given a version of 
their programme to exercise at home. 
2. To examine the feasibility of conducting a neuropilates class in this patient cohort 
3. To investigate any adverse effects of group neuropilates training in this population. 
4. To investigate the need for additional and supportive equipment to enable neuropilates group 
training in this client group. 
 
Study Design: 
 
The Design is an assessor blinded, randomised control pilot feasibility trial.  The independent 
assessor, who is blinded to the treatment assignment, will perform all the assessments.  After 
baseline measurements are obtained, the patients will be randomly assigned to the intervention 
or control group using computer generated block random numbers where gender and function 
will be considered. A statistician who will be blinded to the research protocol and not otherwise 
involved in the trial will conduct the random number programme. 
 
Setting: 
 
Assessments: Exercise Physiology Lab, IT Sligo. 
Exercise Classes: Physiotherapy Department, St. John’s Hospital, Ballytivnan, Sligo. 
 
Intervention: 
 
Experimental Group:  
The intervention group will attend a once-weekly 60-minute neuropilates exercise class for 6 
weeks facilitated by the principal investigator (a chartered physiotherapist who is also a 
pilates instructor). Participants will be asked to participate in exercises in a group setting 
targeted at improving their posture, core stability, flexibility, abdominal and pelvic strength 
and balance. These exercises will be pitched at a beginner level focused on the core elements 
of neuropilates and progressing week on week as appropriate.  
 
The exercise class will include 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. Exercises may be modified by the physiotherapist to suit the needs of 
the participant and supportive equipment may be used as necessary.  
 
It is hoped that there will be two classes running with 7 to 8 participants in each. The classes 
will be split based on their initial assessment into the higher functionally independent 
participants and the lower functionally independent participants. Examples of some typical 
pilates exercises for lower functioning patients would be; seated scapular setting exercises, 
seated thoracic mobility exercises, seated transversus abdominis activation with leg lifts, knee 
extension or hip abduction, simple standing balance exercises, supported squats and 
strengthening exercises with therabands in supported positions. For the more able patients 
who can get on and off a mat on the floor with ease, exercises may be more challenging, for 
example, clams, side leg lifts, exercises in “table top” position (supine, with one or both legs 
off the floor flexed at the knees and hips), exercises in 4 point kneeling, exercises in prone 
and more challenging standing balance and squatting exercises.  
 
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.  
 
 
Control Group 
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. 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.  
 
Outcome Assessments: 
 
Outcome Measures will be taken before and after the 6-week class / home exercise 
programme period and at 3 months follow up and will include: 
 
Primary:  
Gait analysis: Timed Up & Go Test (G Walk BTS bioengineering) 
Motor Assessment Scale for stroke (Carr and Shepherd 1985) 
 
Secondary:  
Strength: Oxford grading scale 
Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987) 
Function: Functional Independence Measure, FIM (Granger et al 1993) 
London Handicap Scale (Harwood et al 1994)