- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404631
Effect of Intermittent Pneumatic Compression on Ankle Joint Proprioception and Balance in Patients With Stroke
February 5, 2026 updated by: Heba Ashraf Sayed Abd El Hadi, Cairo University
This study aims to assess the effect of intermittent pneumatic compression on ankle joint proprioception and balance in patients with stroke.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Stroke is a leading cause of disability worldwide, often resulting in motor impairments that limit mobility, daily activities, social participation, and overall quality of life.
Although many stroke survivors regain independent ambulation, deficits in balance, posture, and gait commonly persist due to impaired voluntary motor control of the paretic lower limb.
Recovery of lower limb motor function is essential for walking, independence in activities of daily living, and social participation.
Proprioception, which provides sensory information about body position and movement, plays a critical role in motor control and functional performance.
Proprioceptive deficits are common after stroke and are more pronounced in the lower limb, contributing to impaired balance, gait disturbances, and increased fall risk.
Stroke rehabilitation aims to restore function through interventions that enhance sensory input, promote cortical plasticity, and improve motor recovery.
Therefore, this study aims to assess the effect of intermittent pneumatic compression on ankle joint proprioception and balance in patients with stroke.
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nagwa Ibrahim Rehab, PhD
Study Contact Backup
- Name: Heba Ashraf Sayed Abd El-Hadi, M.Sc
- Phone Number: +20 11 10635773
- Email: hebaashraf66677@yahoo.com
Study Locations
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Cairo, Egypt
- Ministry of health
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Contact:
- Heba Ashraf Sayed Abd El-Hadi
- Phone Number: +20 11 10635773
- Email: hebaashraf66677@yahoo.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The age of the patients will range from 50-65 years old.
- Patients with stroke duration of illness ranged from six months to 18 months.
- BMI (Body Mass Index) ranged from 20- 30 Kg/m2.
- The muscle tone of the affected lower limb muscles ranged from 1 to 2 grade according Modified Aschworth Scale.
- Patients who have moderate impaired balance.
- Patients who have impaired proprioception.
Exclusion Criteria:
- Patients with cardiovascular problems (open heart surgery or pacemaker).
- Patients with neurological diseases that affect lower limb function other than stroke (ex: Multiple sclerosis, Peripheral neuropathy, Parkinsonism…. etc.).
- Patients Suffered of Deep veins thrombosis (DVT).
- Patient with recurrent stroke.
- Patients with musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures or contractures of fixed deformity, leg length discrepancy after total hip replacement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Intermitted pneumatic pressure + Conventional physical therapy
Participants will receive the intermitted pneumatic pressure in addition to conventional physical therapy, 3 times per week for six weeks.
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Intermittent pneumatic compression will be applied with the patient positioned comfortably in a supported supine lying position on an appropriately sized treatment table.
The treated limb will be inspected for skin integrity, with any bandages removed, and a cotton gauze sleeve will be applied prior to placement of the compression sleeve.
The compression unit will be placed on a stable surface, checked for cleanliness and proper assembly, and securely connected to the limb.
Treatment parameters will be set at a pressure of 40 mmHg with an intermittent cycle of 90 seconds of inflation followed by 90 seconds of deflation.
Each treatment session will last 30 minutes.
Conventional physical therapy will be received in the form of range of motion exercises, strength exercise, stretching exercises, sit to stand, proprioception training and balance training, 3 times per week for 6 weeks.
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Active Comparator: Conventional physical therapy
Participants will receive conventional physical therapy only, 3 times per week for six weeks.
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Conventional physical therapy will be received in the form of range of motion exercises, strength exercise, stretching exercises, sit to stand, proprioception training and balance training, 3 times per week for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ankle proprioception
Time Frame: 6 weeks
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It will be assessed by measuring the absolute error between target and reproduced ankle angles using an isokinetic dynamometer.
Participants attempt to reproduce 10° and 20° of plantar flexion without visual feedback.
The absolute error represents the difference between the target and reproduced angles.
Smaller errors indicate better proprioceptive accuracy, while larger errors reflect impaired proprioception.
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6 weeks
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Mediolateral Stability Index (MLSI)
Time Frame: 6 weeks
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It reflects the individual's ability to control balance from side to side.
Measured on the Biodex Balance System, it quantifies mediolateral sway.
Higher MLSI values indicate increased instability, while lower values reflect better control.
It is particularly useful for assessing balance deficits in conditions like stroke, where lateral stability is often impaired, aiding in targeted rehabilitation strategies.
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6 weeks
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Anteroposterior Stability Index (APSI)
Time Frame: 6 weeks
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It measures front-to-back balance control using the Biodex Balance System.
It evaluates how well an individual stabilizes posture in the forward and backward directions.
Elevated APSI scores indicate greater postural sway and instability, while lower scores indicate better balance.
This index is critical in identifying anteroposterior balance deficits and guiding targeted rehabilitation.
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6 weeks
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Overall Stability Index (OSI)
Time Frame: 6 weeks
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is a composite measure reflecting balance control in all directions-mediolateral and anteroposterior.
Assessed via the Biodex Balance System, a higher OSI indicates greater overall body sway and instability.
Lower OSI values reflect better multi-directional balance.
This index is crucial in providing a global assessment of postural control and is used to monitor progress in balance rehabilitation.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Limits of Stability (LOS) score
Time Frame: 6 weeks
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LOS test evaluates patient's ability to intentionally shift center of gravity in eight directions (Forward, Backward, Right, Left, Forward-Right, Forward-Left, Backward-Right, Backward-Left) without losing balance.
Three trials per direction; averages calculated.
Lower scores indicate restricted stability limits common post-stroke, affecting functional mobility and fall risk.
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6 weeks
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The Berg Balance Scale (BBS)
Time Frame: 6 weeks
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It is a 14-item clinical test used to objectively measure balance ability during functional tasks.
Each task is scored from 0 (unable) to 4 (independent), with a total score out of 56.
Lower scores indicate higher fall risk.
It assesses static and dynamic balance in tasks like standing, turning, and reaching.
The BBS is widely used in stroke rehabilitation to evaluate balance improvements over time.
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6 weeks
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The Timed Up and Go (TUG) test
Time Frame: 6 weeks
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It measures functional mobility and fall risk.
Participants stand from a chair, walk 3 meters, turn, return, and sit.
The time in seconds is recorded.
A completion time of ≥12 seconds indicates increased fall risk.
The TUG is a simple, reliable test used in clinical settings to track progress in mobility and balance rehabilitation.
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mohammad Sadik Badway, PhD, Professor, Cairo university
- Study Director: Ebtessam Mohamed Fahmy, PhD, Professor, Cairo university
- Study Director: Nagwa Ibrahim Rehab, PhD, Assis. Professor, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 12, 2026
Primary Completion (Estimated)
August 12, 2026
Study Completion (Estimated)
August 12, 2026
Study Registration Dates
First Submitted
February 5, 2026
First Submitted That Met QC Criteria
February 5, 2026
First Posted (Actual)
February 11, 2026
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005794
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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