Online Neuropilates Classes in Chronic Stroke Patients: A Pilot Randomised Feasibility Study

Sponsor
Institute of Technology, Sligo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05739422
Collaborator
Sligo General Hospital (Other)
20
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3
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Neuropilates online exercise class
  • Procedure: Online generalised exercise class
  • Procedure: Unsupervised home exercise programme
N/A

Detailed Description

Stroke survivors often demonstrate balance and mobility deficits and low physical activity levels. They experience barriers to physical exercise including embarrassment, low self-efficacy and a shortage of tailored community exercise programmes. Access to physical activity programmes for stroke survivors could be improved by providing tailored, online programmes, although little is known about the safety and feasibility of online exercise classes for stroke survivors. One such programme of exercise which has received little attention in the literature is neuropilates. Neuropilates is the practice of a modified pilates programme in those with neurological conditions, is theorised to have beneficial effects on strength, balance and proprioception in stroke survivors. No randomised controlled trial has previously been conducted to investigate online, remotely supervised neuropilates exercise classes in the stroke survivors.

This single assessor blinded randomised control pilot feasibility trial will compare a 6-week online, remotely instructed neuropilates programme to a 6-week online, remotely instructed generalised exercise programme and a 6-week unsupervised generalised home exercise programme in chronic stroke patients. Twenty adults, at least 6 months post acute stroke, and finished their formal rehabilitation will be recruited to the study. Outcome measures will include balance, gait, tone and quality of life assessments and will be completed at baseline, on programme completion and 3 months post completion by a Physiotherapist blinded to the group allocation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilot randomised controlled feasibility trialPilot randomised controlled feasibility trial
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessor will be blinded to treatment allocation
Primary Purpose:
Treatment
Official Title:
An Investigation in Online Neuropilates Classes in Chronic Stroke Patients: A Pilot Randomised Feasibility Study'
Actual Study Start Date :
Nov 16, 2022
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Participants 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

Procedure: Neuropilates online exercise class
Online, remotely supervised neuropilates exercise class

Active Comparator: Control Group A

Participants 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.

Procedure: Online generalised exercise class
Online, remotely supervised generalised exercise class

Active Comparator: Control Group B

Participants 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.

Procedure: Unsupervised home exercise programme
Unsupervised, home based generalised exercise programme

Outcome Measures

Primary Outcome Measures

  1. Timed Up and Go Assessment (Podsiadlo and Richardson 1991) [Over a 6 week period, 2-3 minute assessment]

    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.

  2. Tinetti Balance and Gait Assessment (Tinetti et al, 1986) [Over a 6 week period, 15 minute assessment]

    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

  3. The Activites Specific Balance Confidence Scale (Powell and Myers 1995) [Over a 6 week period, 10 minute assessment]

    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.

Secondary Outcome Measures

  1. 5 Times Sit to Stand Test (Csuka and Mccarthy 1985) [Over a 6 week period, 2 - 3 minute assessment]

    The 5TSTS was chosen as a measure of lower limb strength and function. The participant will be instructed to stand and sit 5 times from a standard armchair as quickly as possible and their effort will be timed. An inability to perform 5 repetitions without assistance or use of the upper limb indicates failure of the test. A cut off score of greater than 15 seconds has predictability value in identifying recurrent fallers

  2. The Stroke Specific Quality of Life Scale (Williams et al, 1999) [Over a 6 week period. 20 minute assessment]

    The SSQOL was chosen to measure health-related quality of life. It is a self-reported scale containing 49 items in 12 domains: mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning.

  3. The Modified Ashworth Scale (Bohannon and Smith 1987) [Over a 6 week period, 20 minute assessment]

    The MAS was chosen as it is considered the primary clinical measure of muscle spasticity in patients with neurological conditions. The MAS was applied to the muscle groups of the upper and lower limbs in supine and side lying. The MAS is a scored on a 6-point scale with scores ranging from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Aged > 18 years

  2. Diagnosis of chronic stroke (>6 months post stroke event [30]) and formal rehabilitation completed.

  3. Able to transfer and mobilise > 10 metres independently with or without assistive device

  4. Internet access in their homes: Wifi or access to someone with mobile data

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atlantic Technological University Sligo Ireland

Sponsors and Collaborators

  • Institute of Technology, Sligo
  • Sligo General Hospital

Investigators

  • Study Director: Kenneth Monaghan, PhD, Research Supervisor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kenneth Monaghan, Director Kenneth Monaghan, Institute of Technology, Sligo
ClinicalTrials.gov Identifier:
NCT05739422
Other Study ID Numbers:
  • ONPRCT
First Posted:
Feb 22, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kenneth Monaghan, Director Kenneth Monaghan, Institute of Technology, Sligo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2023