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

NCT07404631 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005794
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Ankle proprioception

  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.

  6 weeks

• Mediolateral Stability Index (MLSI)

  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.

  6 weeks

• Anteroposterior Stability Index (APSI)

  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.

  6 weeks

• Overall Stability Index (OSI)

  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.

  6 weeks

Secondary Outcomes (3)

• Limits of Stability (LOS) score

  6 weeks

• The Berg Balance Scale (BBS)

  6 weeks

• The Timed Up and Go (TUG) test

  6 weeks

Study Arms (2)

Intermitted pneumatic pressure + Conventional physical therapy

EXPERIMENTAL

Participants will receive the intermitted pneumatic pressure in addition to conventional physical therapy, 3 times per week for six weeks.

Device: Intermitted pneumatic pressure; Other: Conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

Participants will receive conventional physical therapy only, 3 times per week for six weeks.

Other: Conventional physical therapy

Interventions

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.

Intermitted pneumatic pressure + Conventional physical therapy

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.

Conventional physical therapy; Intermitted pneumatic pressure + Conventional physical therapy

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ministry of Health

Cairo, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mohammad Sadik Badway, PhD

  Professor, Cairo University

  STUDY CHAIR

• Ebtessam Mohamed Fahmy, PhD

  Professor, Cairo University

  STUDY DIRECTOR

• Nagwa Ibrahim Rehab, PhD

  Assis. Professor, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Heba Ashraf Sayed Abd El-Hadi, M.Sc

CONTACT

+20 11 10635773; hebaashraf66677@yahoo.com

Nagwa Ibrahim Rehab, PhD

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

EG (1)