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NCT Number: NCT07404631

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

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

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermitted pneumatic pressure

Device

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

Other

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.

Primary outcomes

  1. Ankle proprioception

    Time frame: 6 weeks

    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.

  2. Mediolateral Stability Index (MLSI)

    Time frame: 6 weeks

    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.

  3. Anteroposterior Stability Index (APSI)

    Time frame: 6 weeks

    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.

  4. Overall Stability Index (OSI)

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Limits of Stability (LOS) score

    Time frame: 6 weeks

    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.

  2. The Berg Balance Scale (BBS)

    Time frame: 6 weeks

    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.

  3. The Timed Up and Go (TUG) test

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heba Ashraf Sayed Abd El-Hadi, M.Sc

CONTACT

[email protected]

+20 11 10635773

Nagwa Ibrahim Rehab, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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