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Effect of Intermittent Pneumatic Compression on Ankle Joint Proprioception and Balance in Patients With Stroke

Effect of Intermittent Pneumatic Compression on Ankle Joint Proprioception and Balance in Patients With Stroke

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07404631
Enrollment
56
Registered
2026-02-11
Start date
2026-02-12
Completion date
2026-08-12
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

This study aims to assess the effect of intermittent pneumatic compression on ankle joint proprioception and balance in patients with stroke.

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.

Interventions

DEVICEIntermitted pneumatic pressure

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.

OTHERConventional physical therapy

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anteroposterior Stability Index (APSI)6 weeksIt 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.
Ankle proprioception6 weeksIt 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.
Mediolateral Stability Index (MLSI)6 weeksIt 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.
Overall Stability Index (OSI)6 weeksis 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.

Secondary

MeasureTime frameDescription
The Berg Balance Scale (BBS)6 weeksIt 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.
Limits of Stability (LOS) score6 weeksLOS 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.
The Timed Up and Go (TUG) test6 weeksIt 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.

Countries

Egypt

Contacts

STUDY_CHAIRMohammad Sadik Badway, PhD

Professor, Cairo University

STUDY_DIRECTOREbtessam Mohamed Fahmy, PhD

Professor, Cairo University

STUDY_DIRECTORNagwa Ibrahim Rehab, PhD

Assis. Professor, Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026