- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293416
Neuropilates and Otago Exercises on Balance, Posture and Functional Independence in Chronic Stroke
Comparative Effects of Neuropilates and Otago Exercises on Balance, Posture and Functional Independence in Individuals With Chronic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic stroke survivors often face profound challenges that considerably impact their balance, posture, and functional independence. These issues can compromise their ability to perform daily activities, reduce their quality of life, and lead to increased dependency on caregivers. Effective rehabilitation strategies are essential for improving these aspects of recovery. Neuropilates, a novel approach that merges the foundational principles of Pilates with targeted neurological rehabilitation techniques, has shown promise in enhancing physical and cognitive function. By focusing on core strength, flexibility, and body awareness, Neuropilates aims to facilitate motor learning and improve overall stability. This study is designed to compare the effectiveness of Neuropilates with Otago exercises-an evidence-based program specifically designed to enhance strength and balance in older adults-on key rehabilitation outcomes for individuals living with chronic stroke. The Otago program emphasizes lower limb strength and balance training, making it a relevant comparison for assessing improvements in functionality.
The randomized clinical trial will be conducted at various physical therapy clinics of Faisalabad over a six-month period, enrolling a total of 32 participants selected through non probability convenience sampling technique. Participants will be randomly assigned to one of two groups: those undergoing Neuropilates and those performing Otago exercises, with each group consisting of 16 individuals. Assessments will utilize the TUG (Timed Up and Go) to evaluate balance, the Postural Assessment Scale for Stroke Patients (PASS) for posture, and the Functional Independence Measure (FIM) for functional independence. Pre-intervention assessments will establish baseline measures, followed by evaluations at 4 weeks, and post-intervention to track progress. Data analysis will be conducted using SPSS 26 software, allowing for a comprehensive comparison of the interventions' effectiveness. The findings from this study will contribute valuable insights for clinicians and rehabilitation specialists, enhancing therapeutic strategies to support chronic stroke patients in regaining their independence.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zobia Tariq, MS-NMPT
- Phone Number: 03321751888
- Email: zobiatariqmul@gmail.com
Study Locations
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Faisalabad, Pakistan
- Al-Mahmood Physiotherapy Clinic
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Faisalabad, Pakistan
- Faisal Hospital Faisalabad
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Faisalabad, Pakistan
- Syeda Khatoon e Jannat Trust Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 40-70 years
- Both male and female
- Chronic stroke, 6-18 months post-stroke
- Stroke severity score >6 on NIHSS
- MMSE ≥24
Exclusion Criteria:
• Symptoms of global or receptive aphasia
- Other neurological disorders: tumors, anoxia, TBI, neurodegenerative diseases, ataxia.
- Significant cardiorespiratory conditions
- Currently receiving other complementary interventions
- Severe motor impairment preventing safe participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A : Neuropilates
This group will receive 50 minutes session of Neuropilates thrice a week for total of eight weeks which will include activation warm-up exercises for 10 minutes, main exercises for 30 minutes and cool-down exercises for 10 minutes
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50 minutes session of Neuropilates thrice a week for total of eight weeks which will include activation warm-up exercises for 10 minutes, main exercises for 30 minutes and cool-down exercises for 10 minutes
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Active Comparator: Group B : Otago Exercise Program
This group will receive 50 minutes each session of Otago exercise thrice a week for total of eight weeks which will include, muscle strengthening, balance training and 2x week 30 minutes walking session.
Depending on the individual's strength and mobility, the exercises will be progressed, by increasing the amount of repetitions or weight
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50 minutes each session of Otago exercise thrice a week for total of eight weeks which will include, muscle strengthening, balance training and 2x week 30 minutes walking session.
Depending on the individual's strength and mobility, the exercises will be progressed, by increasing the amount of repetitions or weight
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Postural Assessment Scale for Stroke (PASS)
Time Frame: baseline, 4thweek, 8thweek
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The Postural Assessment Scale for Stroke (PASS) is designed to evaluate postural control after stroke.
It consists of 12 four-level items assessing the ability to maintain or change positions in lying, sitting, and standing.
Scores range from 0 to 36, with 0-12 indicating poor, 13-24 moderate, and 25-36 good postural control.
The PASS has excellent inter-rater reliability (α = 0.88, range 0.64-1) and total score reliability (r = 0.99, p < 0.001).
Test-retest reliability in chronic stroke patients is also high (ICC = 0.84-0.97).
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baseline, 4thweek, 8thweek
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The Functional Independence Measure (FIM)
Time Frame: baseline, 4thweek, 8thweek
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The Functional Independence Measure (FIM) is used to assess the functional independence of individuals recovering from illness or disability.
It includes 18 items covering self-care, mobility, locomotion, communication, and social cognition.
Each item is rated on a 7-point scale (1 = total dependence to 7 = complete independence), giving a total score between 18 and 126.
Higher scores indicate greater independence.
The FIM demonstrates high inter-rater reliability (ICC = 0.86-0.88).
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baseline, 4thweek, 8thweek
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Timed Up and Go (TUG)
Time Frame: baseline, 4thweek , 8thweek
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The Timed Up and Go (TUG) test is a simple, quick, and reliable tool used to assess mobility, balance, and fall risk in individuals with neurological or musculoskeletal conditions.
It measures the time taken to stand up from a chair, walk three meters, turn, return, and sit down.
A cut-off time of 12 seconds or more indicates a high risk of falling.
The test is suitable for people with stroke, Parkinson's disease, multiple sclerosis, hip fracture, or joint replacement.
It requires only a chair, stopwatch, and three-meter mark and allows observation of gait, stability, and use of aids.
The test shows a sensitivity and specificity of about 87% for identifying fall risk in the elderly population.
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baseline, 4thweek , 8thweek
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Binash Afzal, Riphah International University
Publications and helpful links
General Publications
- Cronin E, Broderick P, Clark H, Monaghan K. What are the effects of pilates in the post stroke population? A systematic literature review & meta-analysis of randomised controlled trials. J Bodyw Mov Ther. 2023 Jan;33:223-232. doi: 10.1016/j.jbmt.2022.09.028. Epub 2022 Sep 29.
- Chen SC, Lin CH, Su SW, Chang YT, Lai CH. Feasibility and effect of interactive telerehabilitation on balance in individuals with chronic stroke: a pilot study. J Neuroeng Rehabil. 2021 Apr 26;18(1):71. doi: 10.1186/s12984-021-00866-8.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/S24C14G37016 Zobia Tariq
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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