Neuropilates Compared to General Exercise Classes in Chronic Stroke

NCT04491279 | Completed

• 1 other identifier: ITSligo EC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Neuroplasticity; Neuropilates; Chronic Stroke; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Over a 6 week period. (15 min testing time).

Secondary Outcomes (5)

• Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000).

  Over a 6 week period. (1 min testing time).

• Muscle Strength: Oxford Grading Scale.

  Over a 6 week period. (5-20 min testing time).

• Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987).

  Over a 6 week period. (5-20 min testing time).

• Function: Functional Independence Measure (FIM), (Granger et al 1993).

  Over a 6 week period. (30-45 min testing time).

• London Handicap Scale (LHS), (Harwood et al 1994).

  Over a 6 week period. (5 min testing time).

Study Arms (2)

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.

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.

Procedure: Home 'General' exercise instructions.; Procedure: Supervised General Exercises Group Class

Interventions

Home 'General' exercise instructions. PROCEDURE

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.

Generalised exercise class.

Home 'Neuropilates' exercise instructions. PROCEDURE

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.

Neuropilates class.

Supervised Neuropilates Group Class PROCEDURE

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).

Neuropilates class.

Supervised General Exercises Group Class PROCEDURE

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

Generalised exercise class.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Dr. John Bartlett: lead
• Sligo General Hospital: collaborator
• Institute of Technology, Sligo: collaborator

Study Sites (1)

Institute of Technology, Sligo

Sligo, Co Sligo, F91YW50, Ireland

Location

Related Publications (1)

• Cronin 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.

  PMID: 36747990 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eimear Cronin, MSc Res

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

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. They will evaluate participant's prior to neuropilates treatment commencing and after neuropilates 6 week treatment has been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research

Model Details: Pilot Randomised Controlled Trial

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: July 29, 2020
• Study Start: October 30, 2020
• Primary Completion: April 30, 2021
• Study Completion: January 31, 2022
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

IE (1)