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Clinical Trials/NCT05739422
NCT05739422CompletedNot Applicable

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

Institute of Technology, Sligo1 site in 1 country12 target enrollmentStarted: November 16, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Tinetti Balance and Gait Assessment (Tinetti et al, 1986)

Study Overview

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

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.

The proposed randomised controlled feasibility study will begin to address some of the afore mentioned gaps in the literature base and determine whether the intervention should be recommended for efficacy testing in line with the standards set for feasibility trials by Bowen et al, 2009. The aim of the study is to conduct a randomised controlled feasibility study to examine the feasibility and clinical outcomes on stroke survivors of a live, online, once weekly, six-week neuropilates exercise class when compared to two control groups. The first control group will be participating in a live, online, once weekly, supervised, six-week generalised exercise class. The second control group will be given a home exercise programme to carry out unsupervised.

Research Design and Methods:

Study Design The design of the trial is a single (assessor) blinded, randomised controlled feasibility study. Due to the nature of the intervention, neither the instructing therapist nor the participant can be blinded to group allocation. An independent assessor, who is blinded to the treatment assignment, will perform all clinical outcome assessments. Participants were asked not to discuss their allocation with their assessors on post assessment. Participants will undergo stratified random sampling, following an initial phone screening conversation. The sampling frame will be 20 - 25 potential participants. The age of the participants and functional status will be the strata considered during this randomisation process to ensure a representative sample in each group with factors that could influence outcome accounted for. In terms of functional ability, higher functionally independent participants will be considered to be those who can walk without an assistive device and lower functionally independent participants will be those who need an assistive device to walk. There will then be four strata from which random sampling will extract from; 1) Less than 65 years, lower functioning, 2) Greater than 65 years, lower functioning, 3) Less than 65 years, higher functioning, 4) Greater than 65 years, higher functioning. Participants from stratum 1 will be divided into intervention and control groups by the following method; all names will be placed into envelopes, shuffled and divided as evenly as possible into intervention and control groups by an independent researcher. This process will be repeated for the rest of the strata. This should result in an even, random spread from each stratum across all groups.

Study Setting:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessor will be blinded to treatment allocation

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged > 18 years
  • Diagnosis of chronic stroke (>6 months post stroke event [30]) and formal rehabilitation completed.
  • Able to transfer and mobilise > 10 metres independently with or without assistive device
  • Internet access in their homes: Wifi or access to someone with mobile data
  • Cognitive ability to understand the programme.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Tinetti Balance and Gait Assessment (Tinetti et al, 1986)

Time Frame: 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

Timed Up and Go Assessment (Podsiadlo and Richardson 1991)

Time Frame: 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.

The Activites Specific Balance Confidence Scale (Powell and Myers 1995)

Time Frame: 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 Outcomes

  • 5 Times Sit to Stand Test (Csuka and Mccarthy 1985)(Over a 6 week period, 2 - 3 minute assessment)
  • The Stroke Specific Quality of Life Scale (Williams et al, 1999)(Over a 6 week period. 20 minute assessment)
  • The Modified Ashworth Scale (Bohannon and Smith 1987)(Over a 6 week period, 20 minute assessment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kenneth Monaghan

Director Kenneth Monaghan

Institute of Technology, Sligo

Study Sites (1)

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