StrokeNCT07404631
Effect of Intermittent Pneumatic Compression on Ankle Joint Proprioception and Balance in Patients With Stroke
A study testing Intermitted pneumatic pressure and Conventional physical therapy in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to assess the effect of intermittent pneumatic compression on ankle joint proprioception and balance in patients with stroke. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intermitted pneumatic pressure and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the effect of intermittent pneumatic compression on ankle joint proprioception and balance in patients with stroke.
Read the 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.
- Conditions
- Stroke
- Being tested
- Intermitted pneumatic pressure, Conventional physical therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermitted pneumatic pressureDevice
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (3)
Limits of Stability (LOS) score
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.
Measured: 6 weeks
The Berg Balance Scale (BBS)
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.
Measured: 6 weeks
The Timed Up and Go (TUG) test
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start12 Feb 2026
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ashraf Sayed Abd El Hadi, Cairo University
- Investigators
- Mohammad Sadik Badway, PhD, Study chair, Professor, Cairo UniversityEbtessam Mohamed Fahmy, PhD, Study director, Professor, Cairo UniversityNagwa Ibrahim Rehab, PhD, Study director, Assis. Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404631
- Sponsor's protocol ID
- P.T.REC/012/005794
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Pneumatic Compression on Ankle Joint Proprioception and Balance in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07404631
- Acronym / sponsor ID
- P.T.REC/012/005794
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermitted pneumatic pressure + Conventional physical therapy | Experimental | Device: Intermitted pneumatic pressure, Other: Conventional physical therapyParticipants will receive the intermitted pneumatic pressure in addition to conventional physical therapy, 3 times per week for six weeks. |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapyParticipants will receive conventional physical therapy only, 3 times per week for six weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermitted pneumatic pressureIntermittent 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. | Device | Intermitted pneumatic pressure + Conventional physical therapy |
| Conventional physical therapyConventional 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. | Other | Conventional physical therapy, Intermitted pneumatic pressure + Conventional physical therapy |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Limits of Stability (LOS) score
Time frame: 6 weeks
The Berg Balance Scale (BBS)
Time frame: 6 weeks
The Timed Up and Go (TUG) test
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Sadik Badway, PhD study chair
Professor, Cairo University
Ebtessam Mohamed Fahmy, PhD study director
Professor, Cairo University
Nagwa Ibrahim Rehab, PhD study director
Assis. Professor, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermitted pneumatic pressure and Conventional physical therapy in people with Stroke, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle proprioception (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.