NCT07293416

Brief Summary

This 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 8, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Balance, Chronic Stroke, Functional Independence, Neuropilates, Otago exercises.

Outcome Measures

Primary Outcomes (3)

  • The Postural Assessment Scale for Stroke (PASS)

    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).

    baseline, 4thweek, 8thweek

  • The Functional Independence Measure (FIM)

    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).

    baseline, 4thweek, 8thweek

  • Timed Up and Go (TUG)

    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.

    baseline, 4thweek , 8thweek

Study Arms (2)

Group A : Neuropilates

EXPERIMENTAL

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

Other: neuropilates

Group B : Otago Exercise Program

ACTIVE COMPARATOR

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

Other: otago exercises

Interventions

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

Group A : Neuropilates

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

Group B : Otago Exercise Program

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70 years
  • Both male and female
  • Chronic stroke, 6-18 months post-stroke
  • Stroke severity score \>6 on NIHSS
  • MMSE ≥24

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Al-Mahmood Physiotherapy Clinic

Faisalabad, Pakistan

Location

Faisal Hospital Faisalabad

Faisalabad, Pakistan

Location

Syeda Khatoon e Jannat Trust Hospital

Faisalabad, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 36775522BACKGROUND
  • 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.

    PMID: 33902646BACKGROUND

Study Officials

  • Binash Afzal

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zobia Tariq, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

December 1, 2025

Primary Completion

April 12, 2026

Study Completion

April 30, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations